Page last updated: 2024-11-04

hydromorphone

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Description

Hydromorphone: An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

hydromorphone : A morphinane alkaloid that is a hydrogenated ketone derivative of morphine. A semi-synthetic drug, it is a centrally acting pain medication of the opioid class. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID5284570
CHEMBL ID398707
CHEBI ID5790
SCHEMBL ID2255
MeSH IDM0006409

Synonyms (83)

Synonym
dilaudid
(5alpha)-3-hydroxy-17-methyl-4,5-epoxymorphinan-6-one
hydromorfona [spanish]
morphinan-6-one, 4,5-epoxy-3-hydroxy-17-methyl-, (5alpha)-
laudacon
einecs 207-383-5
hsdb 3341
dilaudid oros
hydromorphonum [inn-latin]
hydromorphone [inn:ban]
novolaudon
dihydromorfinon [czech]
palladone
idromorfone
hidromorfona [inn-spanish]
idromorfone [dcit]
nsc 19046
morphinan-6-one, 4,5-alpha-epoxy-3-hydroxy-17-methyl-
morphinan-6-one, 4,5alpha-epoxy-3-hydroxy-17-methyl-
dea no. 9150
nsc19046
dihydromorphinone
nsc-19046
dimo
morphinan-6-one,5-epoxy-3-hydroxy-17-methyl-, (5.alpha.)-
morphinan-6-one,5.alpha.-epoxy-3-hydroxy-17-methyl-
laudicon
hydromorphon
wln: t b6566 b6/co 4abbc r bx fv ho pn ght&&ttj jq p1
(-)-hydromorphone
morphinone, dihydro-
CHEBI:5790 ,
3-hydroxy-17-methyl-4,5alpha-epoxymorphinan-6-one
hydromorphonum
hydromorfona
dihydromorfinon
hidromorfona
C07042
466-99-9
hydromorphone
7,8-dihydromorphinone
4,5alpha-epoxy-3-hydroxy-17-methyl-6-morphinanone
DB00327
(-)-(5r)-4,5-epoxy-3-hydroxy-9alpha-methylmorphinan-6-one
dimorphone
4,5-epoxy-3-hydroxy-17-methylmorphinan-6-one
6-deoxy-7,8-dihydro-6-oxomorphine
bdbm50241341
jurnista
n02aa03
CHEMBL398707 ,
ids-nh-004
D08047
hydromorphone (inn)
q812464r06 ,
unii-q812464r06
gtpl7082
(4r,4ar,7ar,12bs)-9-hydroxy-3-methyl-1,2,4,4a,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one
hydromorphone [who-dd]
hydrocodone hydrogen tartrate 2.5-hydrate impurity k [ep impurity]
hydromorphone [inn]
hydromorphone [vandf]
hydromorphone [hsdb]
hydromorphone [mi]
SCHEMBL2255
DTXSID8023133 ,
(1s,5r,13r,17r)-10-hydroxy-4-methyl-12-oxa-4-azapentacyclo[9.6.1.0^{1,13}.0^{5,17}.0^{7,18}]octadeca-7(18),8,10-trien-14-one
hydromorphone 1.0 mg/ml in methanol
hydromorphone 0.1 mg/ml in methanol
Q303646
hydromorphone form i
(4r,4ar,7ar,12bs)-9-hydroxy-3-methyl-1,2,4,4a,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one]
hydromorphone form ii
(4r,4ar,7ar,12bs)-9-hydroxy-3-methyl-1,2,4,4a,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one
(1s,5r,13r,17r)-10-hydroxy-4-methyl-12-oxa-4-azapentacyclo[9.6.1.0?,??.0?,??.0?,??]octadeca-7,9,11(18)-trien-14-one
dtxcid603133
(5alpha)-4,5-epoxy-3-hydroxy-17-methylmorphinan-6-one
4,5alpha-epoxy-3-hydroxy-17-methylmorphinan-6-one
hydromorphonum (latin)
hydrocodone hydrogen tartrate 2.5-hydrate impurity k (ep impurity)
hydromorphonum (inn-latin)
hidromorfona (inn-spanish)
hydromorphone, 1mg/ml in methanol

Research Excerpts

Toxicity

Hydromorphone continues to be the first-line medication for postoperative patient-controlled analgesia (PCA) Pharmacokinetic studies have shown that H3G levels in patients with renal insufficiency are 4 times as high as those with normal renal function.

ExcerptReferenceRelevance
"Our findings suggest that SRH is as safe and effective as IRH in the treatment of cancer pain."( A randomized, double-blind, double-dummy, crossover trial comparing the safety and efficacy of oral sustained-release hydromorphone with immediate-release hydromorphone in patients with cancer pain. Canadian Palliative Care Clinical Trials Group.
Bruera, E; Mount, B; Scott, J; Sloan, P; Suarez-Almazor, M, 1996
)
0.29
" In this study, chronic supplementation of intrathecal opioids with bupivacaine was a safe method for providing continued management of chronic pain of cancer or noncancer origin."( Stability, compatibility, and safety of intrathecal bupivacaine administered chronically via an implantable delivery system.
Deer, TR; Elsberry, DD; Hildebrand, KR, 2001
)
0.31
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
" Adverse effects, pain reduction at 5 minutes and 2 hours postbaseline, and additional analgesics and antiemetics were tracked as secondary outcome measures."( Safety and efficacy of hydromorphone as an analgesic alternative to morphine in acute pain: a randomized clinical trial.
Bijur, PE; Chang, AK; Gallagher, EJ; Kenny, MK; Meyer, RH; Solorzano, C, 2006
)
0.33
" Adverse effects were similar in both groups, with the exception of pruritus, which did not occur in patients receiving hydromorphone (0% versus 6% [difference -6%; 95% confidence interval -11% to -1%])."( Safety and efficacy of hydromorphone as an analgesic alternative to morphine in acute pain: a randomized clinical trial.
Bijur, PE; Chang, AK; Gallagher, EJ; Kenny, MK; Meyer, RH; Solorzano, C, 2006
)
0.33
" Adverse events were mild to moderate in severity; the most common of these were constipation, nausea, headache, and somnolence."( Efficacy and safety evaluation of once-daily OROS hydromorphone in patients with chronic low back pain: a pilot open-label study (DO-127).
Khanna, S; Skowronski, R; Thipphawong, J; Tudor, IC; Wallace, M, 2007
)
0.34
" Adverse events were typical of those associated with opioid therapy."( Efficacy and safety evaluation of once-daily OROS hydromorphone in patients with chronic low back pain: a pilot open-label study (DO-127).
Khanna, S; Skowronski, R; Thipphawong, J; Tudor, IC; Wallace, M, 2007
)
0.34
"Despite "clinical lore" among health care providers that treatment with hydromorphone results in improved pain control and fewer adverse side effects, morphine continues to be the first-line medication for postoperative patient-controlled analgesia (PCA)."( The side effects of morphine and hydromorphone patient-controlled analgesia.
Diaz, G; Flood, P; Hong, D, 2008
)
0.35
"The side effect profile was not different between drugs."( The side effects of morphine and hydromorphone patient-controlled analgesia.
Diaz, G; Flood, P; Hong, D, 2008
)
0.35
" Secondary outcomes included numeric rating scale pain scores and adverse events."( Safety and efficacy of rapid titration using 1mg doses of intravenous hydromorphone in emergency department patients with acute severe pain: the "1+1" protocol.
Bijur, PE; Campbell, CM; Chang, AK; Gallagher, EJ; Murphy, MK, 2009
)
0.35
" There were no serious adverse events."( Safety and efficacy of rapid titration using 1mg doses of intravenous hydromorphone in emergency department patients with acute severe pain: the "1+1" protocol.
Bijur, PE; Campbell, CM; Chang, AK; Gallagher, EJ; Murphy, MK, 2009
)
0.35
"" Adverse effects, pain reduction at 10 minutes and 2 hours postbaseline, patient evaluations of satisfaction and pain relief at 30 minutes postbaseline, and use of additional analgesics and antiemetics were tracked as secondary outcomes."( Efficacy and safety profile of a single dose of hydromorphone compared with morphine in older adults with acute, severe pain: a prospective, randomized, double-blind clinical trial.
Baccelieri, A; Bijur, PE; Chang, AK; Gallagher, EJ, 2009
)
0.35
" The incidence of adverse effects from baseline to 30 minutes was not statistically different in the 2 groups."( Efficacy and safety profile of a single dose of hydromorphone compared with morphine in older adults with acute, severe pain: a prospective, randomized, double-blind clinical trial.
Baccelieri, A; Bijur, PE; Chang, AK; Gallagher, EJ, 2009
)
0.35
" The incidence of adverse effects was not statistically different."( Efficacy and safety profile of a single dose of hydromorphone compared with morphine in older adults with acute, severe pain: a prospective, randomized, double-blind clinical trial.
Baccelieri, A; Bijur, PE; Chang, AK; Gallagher, EJ, 2009
)
0.35
" The most frequently reported adverse events were nausea (n = 93, 24."( Long-term safety, tolerability, and efficacy of OROS hydromorphone in patients with chronic pain.
Khanna, S; Moulin, DE; Rauck, RL; Skowronski, R; Thipphawong, J; Tudor, IC; Wallace, M,
)
0.13
" Adverse events included gastrointestinal and central nervous system symptoms."( Open-label study on the long-term efficacy, safety, and impact on quality of life of OROS hydromorphone ER in patients with chronic low back pain.
Thipphawong, J; Wallace, M, 2010
)
0.36
"Pain (visual analogue scale, McGill pain questionnaire, brief pain inventory), patient-controlled analgesia use, adverse events."( Feasibility, safety, and effectiveness of transcranial direct current stimulation for decreasing post-ERCP pain: a randomized, sham-controlled, pilot study.
Beam, W; Borckardt, JJ; Frohman, H; George, MS; Madan, A; Reeves, ST; Romagnuolo, J, 2011
)
0.37
" The incidence of all adverse effects was similar in both groups."( Randomized clinical trial comparing the safety and efficacy of a hydromorphone titration protocol to usual care in the management of adult emergency department patients with acute severe pain.
Bijur, PE; Chang, AK; Gallagher, EJ, 2011
)
0.37
" Pharmacokinetic studies have shown that H3G levels in patients with renal insufficiency are 4 times as high as those with normal renal function; however, reports have been conflicting as to whether or not it is safe to use hydromorphone in renal insufficiency."( Adverse effects in hospice patients with chronic kidney disease receiving hydromorphone.
Paramanandam, G; Prommer, E; Schwenke, DC, 2011
)
0.37
"To provide family physicians with a practical clinical summary of the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain, developed by the National Opioid Use Guideline Group."( Canadian guideline for safe and effective use of opioids for chronic noncancer pain: clinical summary for family physicians. Part 1: general population.
Kahan, M; Mailis-Gagnon, A; Srivastava, A; Wilson, L, 2011
)
0.37
"5%) rated tolerability as "good" or "very good" at Week 52; few patients discontinued treatment because of an adverse event (1."( Sustained safety and efficacy of once-daily hydromorphone extended-release (OROS® hydromorphone ER) compared with twice-daily oxycodone controlled-release over 52 weeks in patients with moderate to severe chronic noncancer pain.
Binsfeld, H; Richarz, U; Sabatowski, R; Szczepanski, L; Waechter, S, 2013
)
0.39
" Descriptive statistics were used to analyze baseline and demographic characteristics, supplemental analgesic use, and incidence of adverse events (AEs)."( Safety and Tolerability of Once-Daily OROS(®) hydromorphone extended-release in opioid-tolerant adults with moderate-to-severe chronic cancer and noncancer pain: pooled analysis of 11 clinical studies.
Hale, ME; Kutch, M; Nalamachu, SR, 2012
)
0.38
" Serious adverse events occurred in 13."( Safety and Tolerability of Once-Daily OROS(®) hydromorphone extended-release in opioid-tolerant adults with moderate-to-severe chronic cancer and noncancer pain: pooled analysis of 11 clinical studies.
Hale, ME; Kutch, M; Nalamachu, SR, 2012
)
0.38
" Common adverse events, which occurred in 91."( Clinical effectiveness and safety of OROS® hydromorphone in break-through cancer pain treatment: a multicenter, prospective, open-label study in Korean patients.
Bae, SH; Cho, YY; Hyun, MS; Kim, JY; Kim, MK; Lee, KH; Lee, SA; Lee, WS; Park, KU; Ryoo, HM; Song, HS,
)
0.13
"The primary outcome measure was the occurrence of adverse events (AEs)."( Safety and tolerability of OROS® hydromorphone ER in adults with chronic noncancer and cancer pain: pooled analysis of 13 studies.
Hale, ME; Kutch, M; Nalamachu, S; Taylor, DR; Wallace, MS,
)
0.13
" Serious adverse events (SAEs) were reported by 10."( Safety and tolerability of OROS® hydromorphone ER in adults with chronic noncancer and cancer pain: pooled analysis of 13 studies.
Hale, ME; Kutch, M; Nalamachu, S; Taylor, DR; Wallace, MS,
)
0.13
" The most common treatment-related adverse events were dizziness, headache, and nausea (two patients each)."( Open-label study to evaluate the efficacy and safety of extended-release hydromorphone in patients with chronic neuropathic pain.
Bansal, R; Fasbinder, S; Nalamachu, S; Nalamasu, R; Ruck, D,
)
0.13
" Treatment-emergent adverse events were comparable between treatment groups."( Safety and efficacy of once-daily hydromorphone extended-release versus twice-daily oxycodone hydrochloride controlled-release in chinese patients with cancer pain: a phase 3, randomized, double-blind, multicenter study.
Han, J; Hou, Y; Richards, HM; Shen, W; Yu, L; Yu, S, 2014
)
0.4
" A trained and blinded observer documented adverse events from the time hydromorphone was administered until the time dogs were induced for surgery."( Effects of maropitant citrate or acepromazine on the incidence of adverse events associated with hydromorphone premedication in dogs.
Chiavaccini, L; Claude, AK; Dedeaux, A; Hinz, S,
)
0.13
" Secondary outcomes were pain scores from 24 to 72 h, intraoperative and postoperative opioid consumption, time to onset of bowel movement and side effect profiles."( Comparison of efficacy and safety of lateral-to-medial continuous transversus abdominis plane block with thoracic epidural analgesia in patients undergoing abdominal surgery: A randomised, open-label feasibility study.
Brookes, J; Das Adhikary, S; Ganapathy, S; Sondekoppam, RV; Subramanian, L; Terlecki, M, 2015
)
0.42
" We describe a prospective, double-blind, parallel group, placebo-controlled randomised controlled trial testing the hypothesis that a novel analgesic drug, VVZ -149, is safe and effective in improving pain compared with providing opioid analgesia alone among adults undergoing laparoscopic colorectal surgery."( Randomised, double-blind, parallel group, placebo-controlled study to evaluate the analgesic efficacy and safety of VVZ-149 injections for postoperative pain following laparoscopic colorectal surgery.
Bao, X; Chin, JW; Cho, S; Correll, DJ; Eng, K; Hamsher, CP; Ledley, J; Lee, DH; Maniam, R; Nedeljkovic, SS; Sorace, J; Tsui, B; Young, MJ; Zamor, N; Zeballos, JL; Zhang, Y, 2017
)
0.46
"To review the safety profile of injectable hydromorphone and diacetylmorphine and explore if adverse events (AEs) or serious adverse events (SAEs) were associated with dose and patterns of attendance."( Safety profile of injectable hydromorphone and diacetylmorphine for long-term severe opioid use disorder.
Anis, AH; Brissette, S; Guh, D; Harrison, S; Janmohamed, A; Jutha, S; Krausz, M; MacDonald, S; Marchand, K; Marsh, DC; Oviedo-Joekes, E; Schechter, MT; Zhang, DZ, 2017
)
0.46
" The secondary endpoints were the incidence of opioid-related adverse effects, recovery results and patient satisfaction after surgery."( Prospective investigation of intravenous patient-controlled analgesia with hydromorphone or sufentanil: impact on mood, opioid adverse effects, and recovery.
Cheng, L; Feng, Z; Li, H; Peng, Z; Wu, J; Xu, X; Yang, Y; Ye, S; Zhu, L, 2018
)
0.48
" Adverse events occurred in 83."( A randomized, double-blind, non-inferiority study of hydromorphone hydrochloride immediate-release tablets versus oxycodone hydrochloride immediate-release powder for cancer pain: efficacy and safety in Japanese cancer patients.
Aruga, E; Inoue, S; Saito, Y; Takahashi, H; Tsuneto, S; Uemori, M, 2018
)
0.48
" In this analysis, using the Medical Dictionary for Regulatory Activities coding system we report somnolence (ie, drowsiness, sleepiness, grogginess) and opioid overdose as adverse events."( Adverse Events During Treatment Induction With Injectable Diacetylmorphine and Hydromorphone for Opioid Use Disorder.
Anis, AH; Brissette, S; Guh, D; Harrison, S; MacDonald, S; Marsh, DC; Oviedo-Joekes, E; Palis, H; Schechter, MT,
)
0.13
" There were 34 related somnolence and adverse event (AE) overdoses (4."( Adverse Events During Treatment Induction With Injectable Diacetylmorphine and Hydromorphone for Opioid Use Disorder.
Anis, AH; Brissette, S; Guh, D; Harrison, S; MacDonald, S; Marsh, DC; Oviedo-Joekes, E; Palis, H; Schechter, MT,
)
0.13
"Opioid-induced respiratory depression (OIRD) and postoperative nausea and vomiting (PONV) are challenging, resource-intensive, and costly opioid-related adverse events (ORAEs)."( Opioid-related respiratory and gastrointestinal adverse events in patients with acute postoperative pain: prevalence, predictors, and burden.
Habib, AS; Iqbal, SU; Kugel, M; Liu, S; Morland, K; Oderda, GM; Senagore, AJ,
)
0.13
"To determine the frequency, severity and duration of adverse events including myoclonus, pain on injection, hypersalivation, regurgitation and apnoea after administration of midazolam or saline followed by etomidate in hydromorphone premedicated dogs."( Descriptive assessment of adverse events associated with midazolam-etomidate versus saline-etomidate in healthy hydromorphone premedicated dogs.
Calbay, R; da Cunha, AF; Hofmeister, EH; Jones, TL, 2021
)
0.62
" Further investigation is needed to determine if midazolam reduced the incidence of adverse events or improved the induction quality when combined with hydromorphone and etomidate."( Descriptive assessment of adverse events associated with midazolam-etomidate versus saline-etomidate in healthy hydromorphone premedicated dogs.
Calbay, R; da Cunha, AF; Hofmeister, EH; Jones, TL, 2021
)
0.62
"In response to the ongoing overdose crisis, some clinicians in Canada have started prescribing immediate release hydromorphone (IRH) as an alternative to the toxic unregulated drug supply."( Characterizing safer supply prescribing of immediate release hydromorphone for individuals with opioid use disorder across Ontario, Canada.
Antoniou, T; Bayoumi, AM; Campbell, T; Gomes, T; Kolla, G; Leece, P; McCormack, D; Srivastava, A; Strike, C; Young, S, 2022
)
0.72
" Adverse events included (a) overdose; (b) intoxication; and (c) diversion, selling, or sharing of medications or alcohol."( Evaluation of an emergency safe supply drugs and managed alcohol program in COVID-19 isolation hotel shelters for people experiencing homelessness.
Atkinson, J; Bonn, M; Brothers, TD; Fraser, J; Genge, L; Gillis, A; Gniewek, M; Hawker, L; Hayman, H; Jorna, P; Leaman, M; Lewer, D; Martell, D; O'Donnell, T; Rivers-Bowerman, H, 2022
)
0.72
"COVID-19 isolation hotel residents participating in an emergency safe supply and managed alcohol program experienced high rates of successful completion of 14 days isolation and low rates of adverse events."( Evaluation of an emergency safe supply drugs and managed alcohol program in COVID-19 isolation hotel shelters for people experiencing homelessness.
Atkinson, J; Bonn, M; Brothers, TD; Fraser, J; Genge, L; Gillis, A; Gniewek, M; Hawker, L; Hayman, H; Jorna, P; Leaman, M; Lewer, D; Martell, D; O'Donnell, T; Rivers-Bowerman, H, 2022
)
0.72
" We aimed to characterize injecting practices among real-world populations of persons who regularly inject buprenorphine, as well as associated adverse events reported in order to inform a possible future BUP iOAT intervention."( Patterns of use and adverse events reported among persons who regularly inject buprenorphine: a systematic review.
Bozinoff, N; Le Foll, B; Rubin-Kahana, DS; Tardelli, VS, 2022
)
0.72
" We searched MEDLINE, EMBASE, and PsycINFO from inception through July 2020 and used backwards citation screening to search for publications reporting on dose, frequency among persons who regularly inject the drug, or adverse events associated with intravenous use of buprenorphine."( Patterns of use and adverse events reported among persons who regularly inject buprenorphine: a systematic review.
Bozinoff, N; Le Foll, B; Rubin-Kahana, DS; Tardelli, VS, 2022
)
0.72
" Adverse events could be characterized as known side effects of opioids/buprenorphine or injection-related complications."( Patterns of use and adverse events reported among persons who regularly inject buprenorphine: a systematic review.
Bozinoff, N; Le Foll, B; Rubin-Kahana, DS; Tardelli, VS, 2022
)
0.72
" YPWUD participants highlighted a disjuncture between RMG prescriptions and the safe supply of unadulterated substances such as fentanyl, underscoring that having access to the latter is critical to reducing their reliance on street-based drug markets and overdose-related risks."( Risk mitigation guidance and safer supply prescribing among young people who use drugs in the context of COVID-19 and overdose emergencies.
Barker, B; Brar, R; Charlesworth, R; Fast, D; Giang, K; Mulholland, A; Pauly, B; Thulien, M, 2023
)
0.91
"Although opioids have been shown to be effective for cancer pain, opioid-induced adverse events (AEs) are common."( Prevalence of opioid-induced adverse events across opioids commonly used for analgesic treatment in Japan: a multicenter prospective longitudinal study.
Arakawa, S; Chiu, SW; Hiratsuka, Y; Hirayama, H; Inoue, A; Ishiki, H; Kosugi, K; Kubo, E; Matsuda, Y; Miyashita, M; Morita, T; Natsume, M; Nishijima, K; Ouchi, K; Sato, M; Satomi, E; Shigeno, T; Shimizu, M; Shimoda, M; Shimoi, T; Tagami, K; Yamaguchi, T; Yokomichi, N, 2023
)
0.91

Pharmacokinetics

Hydromorphone was administered postoperatively on the intensive care unit as target controlled infusion (TCI) or as conventional patient controlled analgesia (PCA)

ExcerptReferenceRelevance
" Our results indicate that hydromorphone pharmacokinetic parameters are linear across a fourfold range of doses that are usually employed clinically and that previously reported pharmacokinetic values for hydromorphone (based on radioimmunoassay measurements) deserve reconsideration."( Multiple-dose evaluation of intravenous hydromorphone pharmacokinetics in normal human subjects.
Coda, BA; Hill, HF; Schaffer, R; Tanaka, A, 1991
)
0.28
" Blood and CSF samples were assayed for morphine and hydromorphone concentration to determine blood and CSF pharmacokinetic profiles."( CSF and blood pharmacokinetics of hydromorphone and morphine following lumbar epidural administration.
Brodsky, JB; Brose, WG; Cousins, MJ; Mark, JBD; Tanelian, DL, 1991
)
0.28
"mL-1, P = NS, Cmax 17."( Steady-state pharmacokinetics of hydromorphone and hydromorphone-3-glucuronide in cancer patients after immediate and controlled-release hydromorphone.
Babul, N; Darke, AC; Dhaliwal, HS; Hagen, N; Harsanyi, Z; Thirlwell, MP, 1995
)
0.29
"0]; median and interquartile range) but was maintained significantly longer at greater than 50% of peak concentration (22."( Pharmacodynamics of orally administered sustained- release hydromorphone in humans.
Angst, MS; Drover, DR; Lötsch, J; Naidu, S; Ramaswamy, B; Stanski, DR; Wada, DR, 2001
)
0.31
" The present assay was applied to a pharmacokinetic study in rat after intraperitoneal administration of hydromorphone."( LC-MS-MS analysis of hydromorphone and hydromorphone metabolites with application to a pharmacokinetic study in the male Sprague-Dawley rat.
McErlane, KM; Ong, MC; Zheng, M, 2002
)
0.31
" Noncompartmental analysis was used to estimate pharmacokinetic variables."( Pharmacokinetics and bioavailability of single-dose intranasal hydromorphone hydrochloride in healthy volunteers.
Archer, SM; Coda, BA; Rudy, AC; Wermeling, DP, 2003
)
0.32
"This study describes the pharmacokinetics of intravenous hydromorphone in cats and the simultaneous measurement of antinociceptive pharmacodynamic effects using a thermal threshold testing system."( Pharmacokinetic and pharmacodynamic evaluation of intravenous hydromorphone in cats.
Kollias-Baker, C; Muir, WW; Robertson, SA; Sams, RA; Wegner, K, 2004
)
0.32
" This study examined the duration of action of BUP at microORs and correlations with pharmacokinetic and pharmacodynamic outcomes in 10 heroin-dependent volunteers."( Buprenorphine duration of action: mu-opioid receptor availability and pharmacokinetic and behavioral indices.
Bueller, J; Chang, Y; Greenwald, M; Johanson, CE; Kilbourn, M; Koeppe, R; Moody, DE; Zubieta, JK, 2007
)
0.34
"Together with our previous findings, it appears that microOR availability predicts changes in pharmacokinetic and pharmacodynamic measures and that about 50%-60% BUP occupancy is required for adequate withdrawal symptom suppression (in the absence of other opioids) and HYD blockade."( Buprenorphine duration of action: mu-opioid receptor availability and pharmacokinetic and behavioral indices.
Bueller, J; Chang, Y; Greenwald, M; Johanson, CE; Kilbourn, M; Koeppe, R; Moody, DE; Zubieta, JK, 2007
)
0.34
"The objective of this study was to compare the pharmacokinetic profile of a novel, once-daily, controlled-release formulation of hydromorphone (OROS hydromorphone) under fasting conditions with that immediately after a high-fat breakfast in healthy volunteers."( Pharmacokinetic profile of a 24-hour controlled-release OROS formulation of hydromorphone in the presence and absence of food.
Gupta, SK; Sathyan, G; Thipphawong, J; Xu, E, 2007
)
0.34
" Confidence intervals were within 80% to 125% for AUC0-t and AUC0-infinity but were slightly higher for Cmax (105."( Pharmacokinetic profile of a 24-hour controlled-release OROS formulation of hydromorphone in the presence and absence of food.
Gupta, SK; Sathyan, G; Thipphawong, J; Xu, E, 2007
)
0.34
" Plasma samples for pharmacokinetic analysis were collected pre-dose and at regular intervals up to 48 hours post-dose (72 hours for the 64-mg dose), and were assayed for hydromorphone concentration to determine peak plasma concentration (Cmax), time at which peak plasma concentration was observed (Tmax), terminal half-life (t1/2), and area under the concentration-time curve for zero to time t (AUC0-t) and zero to infinity (AUC0-infinity)."( Pharmacokinetic investigation of dose proportionality with a 24-hour controlled-release formulation of hydromorphone.
Gupta, SK; Sathyan, G; Thipphawong, J; Xu, E, 2007
)
0.34
" Median Tmax (12."( Pharmacokinetic investigation of dose proportionality with a 24-hour controlled-release formulation of hydromorphone.
Gupta, SK; Sathyan, G; Thipphawong, J; Xu, E, 2007
)
0.34
"The purpose of this study was to investigate the pharmacokinetic properties of a novel, once-daily, controlled-release formulation of hydromorphone (OROS hydromorphone) in the presence of alcohol."( Pharmacokinetic profile of a 24-hour controlled-release OROS formulation of hydromorphone in the presence of alcohol.
Sathyan, G; Sivakumar, K; Thipphawong, J, 2008
)
0.35
" Pharmacokinetic parameters were determined with computer software."( Pharmacokinetics of hydromorphone hydrochloride in healthy dogs.
Hogan, BK; Krugner-Higby, LA; KuKanich, B; Smith, LJ, 2008
)
0.35
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" Plasma hydromorphone only was measured by high pressure liquid chromatography (HPLC) with electrochemical detection and pharmacokinetic parameters calculated."( Pharmacokinetics and physiological effects of intravenous hydromorphone in conscious dogs.
Guedes, AG; Papich, MG; Rider, MA; Rude, EP, 2008
)
0.35
"To describe the pharmacokinetics of hydromorphone (HM) and its primary metabolite hydromorphone-3-glucuronide (H3G) both on and off dialysis in relation to the pharmacodynamic measurements of pain."( Pain management in chronic kidney disease: the pharmacokinetics and pharmacodynamics of hydromorphone and hydromorphone-3-glucuronide in hemodialysis patients.
Davison, SN; Mayo, PR,
)
0.13
"Information and comments on the pharmacokinetic processes associated with a new once-daily formulation of the potent opiod hydromorphone."( The pharmacokinetics of a long-acting OROS hydromorphone formulation.
Gröning, R; Richarz, U; Sathyan, G; Thipphawong, J; Turgeon, J, 2010
)
0.36
"This review presents an overview of data from several small pharmacokinetic studies to gain a better perspective on the pharmacokinetic properties of a new long-acting formulation of hydromorphone."( The pharmacokinetics of a long-acting OROS hydromorphone formulation.
Gröning, R; Richarz, U; Sathyan, G; Thipphawong, J; Turgeon, J, 2010
)
0.36
"The results of these studies indicate that LE-hydro has a pharmacokinetic and behavioral side effects profile consistent with an analgesic that could be tested for surgical use in animals."( Pharmacokinetics and behavioral effects of liposomal hydromorphone suitable for perioperative use in rhesus macaques.
Brown, C; Heath, TD; Krugner-Higby, L; KuKanich, B; Schmidt, B, 2011
)
0.37
" Tramadol is thought to have limited abuse potential compared to mu opioid agonists, but laboratory data indicate that it shares some of their pharmacodynamic effects."( Pharmacodynamic profile of tramadol in humans: influence of naltrexone pretreatment.
Craig, LB; Lofwall, MR; Nuzzo, PA; Siegel, AJ; Stoops, WW; Walsh, SL, 2012
)
0.38
"This study evaluated the effect of mu opioid receptor blockade with naltrexone on the pharmacodynamic action of tramadol in humans."( Pharmacodynamic profile of tramadol in humans: influence of naltrexone pretreatment.
Craig, LB; Lofwall, MR; Nuzzo, PA; Siegel, AJ; Stoops, WW; Walsh, SL, 2012
)
0.38
" Pharmacodynamic effects were measured before and for 7 h after initial drug administration."( Pharmacodynamic profile of tramadol in humans: influence of naltrexone pretreatment.
Craig, LB; Lofwall, MR; Nuzzo, PA; Siegel, AJ; Stoops, WW; Walsh, SL, 2012
)
0.38
" The mean hydrocodone CMAX was 11."( Pharmacokinetics of hydrocodone and hydromorphone after oral hydrocodone in healthy Greyhound dogs.
KuKanich, B; Spade, J, 2013
)
0.39
" Serum opioid concentrations were measured with HPLC-MS and pharmacokinetic parameters were calculated using commercial software and non-compartmental methods."( Pharmacokinetics of ammonium sulfate gradient loaded liposome-encapsulated oxymorphone and hydromorphone in healthy dogs.
Heath, TD; Krugner-Higby, LA; Kukanich, BK; Schmidt, BH; Smith, LJ, 2013
)
0.39
" Population pharmacokinetic parameters were estimated using nonlinear mixed-effects modeling."( Population pharmacokinetic modeling of hydromorphone in cardiac surgery patients during postoperative pain therapy.
Fechner, J; Fröhlich, K; Ihmsen, H; Jeleazcov, C; Krajinovic, L; Mell, J; Saari, TI; Schüttler, J, 2014
)
0.4
"The final pharmacokinetic model gave a robust representation of hydromorphone pharmacokinetics."( Population pharmacokinetic modeling of hydromorphone in cardiac surgery patients during postoperative pain therapy.
Fechner, J; Fröhlich, K; Ihmsen, H; Jeleazcov, C; Krajinovic, L; Mell, J; Saari, TI; Schüttler, J, 2014
)
0.4
" To determine whether ethnic differences affect the drug's pharmacokinetic (PK) profile, we evaluated the dose proportionality of OROS hydromorphone in healthy Taiwanese adults."( Dose proportionality and pharmacokinetics of extended-release (OROS®) hydromorphone: a phase 1, open-label, randomized, crossover study in healthy Taiwanese subjects.
Lu, CC; Richards, HM; Richarz, U; Vandenbossche, J, 2014
)
0.4
" Plasma hydromorphone concentrations were determined by means of liquid chromatography with mass spectrometry, and pharmacokinetic parameters were calculated with a noncompartmental model."( Pharmacokinetics of hydromorphone hydrochloride after intravenous and intramuscular administration of a single dose to American kestrels (Falco sparverius).
Drazenovich, TL; Guzman, DS; KuKanich, B; Olsen, GH; Paul-Murphy, JR, 2014
)
0.4
" After intravenous administration, the median clearance and terminal half-life were 37."( Pharmacokinetics of hydromorphone after intravenous and intramuscular administration in male rhesus macaques (Macaca mulatta).
Christe, KL; Kelly, KR; Pypendop, BH, 2014
)
0.4
" Blood samples were collected for pharmacokinetic analysis of study drugs and their metabolites over an 8-hour period beginning after the second dose of the study medication."( Pharmacokinetics of hydrocodone and tramadol administered for control of postoperative pain in dogs following tibial plateau leveling osteotomy.
Benitez, ME; KuKanich, B; McMurphy, R; Roush, JK, 2015
)
0.42
" The terminal half-life for hydrocodone was 15."( Pharmacokinetics of hydrocodone and tramadol administered for control of postoperative pain in dogs following tibial plateau leveling osteotomy.
Benitez, ME; KuKanich, B; McMurphy, R; Roush, JK, 2015
)
0.42
" This study examined the influence of the coadministration of paroxetine, a strong selective CYP2D6 inhibitor, on the pharmacokinetic properties of hydrocodone (and hydromorphone) in healthy adults."( Effects of paroxetine, a CYP2D6 inhibitor, on the pharmacokinetic properties of hydrocodone after coadministration with a single-entity, once-daily, extended-release hydrocodone tablet.
Cipriano, A; Friedman, K; Harris, SC; Kapil, RP; Michels, G; Mondal, SA; Shet, M, 2015
)
0.42
"Hydrocodone mean Cmax and t½ and median Tmax values were similar with paroxetine or placebo coadministration (16."( Effects of paroxetine, a CYP2D6 inhibitor, on the pharmacokinetic properties of hydrocodone after coadministration with a single-entity, once-daily, extended-release hydrocodone tablet.
Cipriano, A; Friedman, K; Harris, SC; Kapil, RP; Michels, G; Mondal, SA; Shet, M, 2015
)
0.42
"We recently developed a new population pharmacokinetic model for hydromorphone in patients including age and bodyweight as covariates."( External Validation of a Recently Developed Population Pharmacokinetic Model for Hydromorphone During Postoperative Pain Therapy.
Ihmsen, H; Jeleazcov, C; Rohde, D; Schüttler, J, 2017
)
0.46
" Hydromorphone was administered postoperatively on the intensive care unit as target controlled infusion (TCI) for patient controlled analgesia (TCI-PCA) using the new pharmacokinetic model, or as conventional patient controlled analgesia (PCA)."( External Validation of a Recently Developed Population Pharmacokinetic Model for Hydromorphone During Postoperative Pain Therapy.
Ihmsen, H; Jeleazcov, C; Rohde, D; Schüttler, J, 2017
)
0.46
" The mean values (95 % CI) of MDPE, MDAPE, wobble and divergence for the new pharmacokinetic model were 11."( External Validation of a Recently Developed Population Pharmacokinetic Model for Hydromorphone During Postoperative Pain Therapy.
Ihmsen, H; Jeleazcov, C; Rohde, D; Schüttler, J, 2017
)
0.46
"The new pharmacokinetic model of hydromorphone showed a good precision and a better performance than older models."( External Validation of a Recently Developed Population Pharmacokinetic Model for Hydromorphone During Postoperative Pain Therapy.
Ihmsen, H; Jeleazcov, C; Rohde, D; Schüttler, J, 2017
)
0.46
" Noncompartmental analysis of sparse data was used to calculate pharmacokinetic parameters."( Evaluation of the thermal antinociceptive effects and pharmacokinetics of hydromorphone hydrochloride after intramuscular administration to cockatiels (Nymphicus hollandicus).
Beaufrère, H; Guzman, DS; Houck, EL; Knych, HK; Paul-Murphy, JR, 2018
)
0.48
"To determine pharmacokinetic dosing strategy in bearded dragons (Pogona vitticeps) and red-eared sliders (Trachemys scripta elegans) based on two subcutaneously (SC) administered doses of hydromorphone (0."( Pharmacokinetics of subcutaneously administered hydromorphone in bearded dragons (Pogona vitticeps) and red-eared slider turtles (Trachemys scripta elegans).
Cox, S; Hawkins, SJ; Sladky, K; Yaw, TJ, 2019
)
0.51
" Blood samples were taken through 24 hours postdose, and pharmacodynamic end points (Drug Liking, Feeling High, Take Drug Again, Overall Drug Liking) were assessed through eight hours postdose."( Pharmacokinetics and Abuse Potential of Asalhydromorphone, a Novel Prodrug of Hydromorphone, After Intranasal Administration in Recreational Drug Users.
Barrett, AC; Braeckman, R; Guenther, S; Kelsh, D; Mickle, TC; Smith, A; Vince, B, 2020
)
0.56
" Noncompartmental analysis of data was used to calculate pharmacokinetic parameters."( Pharmacokinetics of hydromorphone hydrochloride after intravenous and intramuscular administration in guinea pigs (
Ambros, B; Knych, HK; Sadar, MJ, 2020
)
0.56
"To determine the physiologic and behavioral effects and pharmacokinetic profile of hydromorphone administered intravenously (IV) to horses."( Pharmacokinetics and pharmacodynamics of hydromorphone hydrochloride in healthy horses.
Clark-Price, SC; DiMaio Knych, H; Keating, SC; Lascola, KM; Martins, FC; Schaeffer, DJ, 2020
)
0.56
" Due to lack of data, pediatric dosing (based on adult pharmacokinetic models) is not optimal."( Hydromorphone population pharmacokinetics in pediatric surgical patients.
Balyan, R; Chidambaran, V; Dong, M; Geisler, K; Pilipenko, V; Vinks, AA, 2020
)
0.56
" Nonlinear mixed-effects modeling was used for pharmacokinetic model development."( Hydromorphone population pharmacokinetics in pediatric surgical patients.
Balyan, R; Chidambaran, V; Dong, M; Geisler, K; Pilipenko, V; Vinks, AA, 2020
)
0.56
"Hydromorphone pharmacokinetic profiles were adequately described by a two-compartmental model with first-order elimination."( Hydromorphone population pharmacokinetics in pediatric surgical patients.
Balyan, R; Chidambaran, V; Dong, M; Geisler, K; Pilipenko, V; Vinks, AA, 2020
)
0.56
"After intravenous hydromorphone, plasma pharmacokinetic profiles in children undergoing different surgeries were well described by a two-compartment population allometric pharmacokinetic model using bodyweight as the size descriptor."( Hydromorphone population pharmacokinetics in pediatric surgical patients.
Balyan, R; Chidambaran, V; Dong, M; Geisler, K; Pilipenko, V; Vinks, AA, 2020
)
0.56
" Plasma hydromorphone concentrations were determined with liquid chromatography-tandem mass spectrometry, and pharmacokinetic parameters were calculated with a compartmental model."( Pharmacokinetics of hydromorphone hydrochloride after intramuscular and intravenous administration of a single dose to orange-winged Amazon parrots (
Douglas, J; Knych, H; Paul-Murphy, JR; Sanchez-Migallon Guzman, D, 2020
)
0.56
" Further pharmacokinetic studies of hydromorphone and its metabolites, including investigation of multiple doses, different routes of administration, and sustained-release formulations, are recommended."( Pharmacokinetics of hydromorphone hydrochloride after intramuscular and intravenous administration of a single dose to orange-winged Amazon parrots (
Douglas, J; Knych, H; Paul-Murphy, JR; Sanchez-Migallon Guzman, D, 2020
)
0.56

Compound-Compound Interactions

Low-dose dexmedetomidine combined with hydromorphone is a safe and effective option for postoperative analgesia in PCa patients. It can inhibit the expression of inflammatory factors.

ExcerptReferenceRelevance
"Continuous Reaction Time (CRT) was measured in cancer patients receiving peripherally acting analgesics either alone (n = 16) or in combination with opioids (n = 16)."( Reaction time in cancer patients receiving peripherally acting analgesics alone or in combination with opioids.
Banning, A; Kaiser, F; Sjøgren, P, 1992
)
0.28
"Pharmacokinetic drug-drug interactions with morphine, hydromorphone, and oxymorphone are reviewed in this column."( Pharmacokinetic drug interactions of morphine, codeine, and their derivatives: theory and clinical reality, part I.
Armstrong, SC; Cozza, KL,
)
0.13
"Although caudal morphine may result in more sustained initial analgesia, caudal clonidine combined with nurse-controlled analgesia appears to provide comparable analgesia with fewer side effects."( A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation.
Carvallo, D; Johnson, JL; Mazurek, MS; Presson, RG; Vetter, TR, 2007
)
0.34
"To compare the efficacy and cardiorespiratory effects of dexmedetomidine-ketamine in combination with butorphanol, hydromorphone, or buprenorphine with or without reversal by atipamezole in cats undergoing castration."( Evaluation of dexmedetomidine and ketamine in combination with various opioids as injectable anesthetic combinations for castration in cats.
Austin, BR; Barletta, M; Ko, JC; Krimins, RA; Payton, ME; Weil, AB, 2011
)
0.37
" The objective of the present study was to evaluate the efficacy and safety of OROS® hydromorphone combined with pregabalin in patients with chronic non-cancer neuropathic pain."( Long-term efficacy of OROS® hydromorphone combined with pregabalin for chronic non-cancer neuropathic pain.
Casali, M; Dauri, M; Lazzari, M; Sabato, AF; Sabato, E; Tufaro, G, 2014
)
0.4
"To determine which non-narcotic analgesic, acetaminophen (Ofirmev®) or ketorolac (Toradol®), provides better post-operative pain control when combined with an opioid patient-controlled analgesia (PCA) pump."( A prospective randomized trial of intravenous ketorolac vs. acetaminophen administered with opioid patient-controlled analgesia in gynecologic surgery.
Ahmad, S; Bigsby, GE; Ghurani, GB; Holloway, RW; James, JA; Jeppson, CN; Kendrick, JE; Rakowski, JA, 2019
)
0.51
" The present study was conducted to explore an ideal concentration of nalbuphine for post-CS intravenous analgesia by evaluating the analgesic effects and side-effects of three different concentrations of nalbuphine combined with hydromorphone for post-CS intravenous analgesia in healthy parturients."( A comparative study of three concentrations of intravenous nalbuphine combined with hydromorphone for post-cesarean delivery analgesia.
Chen, XZ; Huang, CY; Li, SX; Xu, LL; Yang, MJ, 2020
)
0.56
"To determine the dose of alfaxalone for IM administration combined with dexmedetomidine and hydromorphone that would allow endoscopic-guided orotracheal intubation in rabbits without causing a decrease in respiratory rate or apnea."( Assessment of intramuscular administration of three doses of alfaxalone combined with hydromorphone and dexmedetomidine for endoscopic-guided orotracheal intubation in domestic rabbits (Oryctolagus cuniculus).
Cremer, J; da Cunha, A; Hampton, CE; Liu, CC; Nevarez, JG; Queiroz-Williams, P; Reabel, SN, 2021
)
0.62
"Increasing doses of alfaxalone combined with hydromorphone and dexmedetomidine increased the success rate of endoscopic-guided orotracheal intubation."( Assessment of intramuscular administration of three doses of alfaxalone combined with hydromorphone and dexmedetomidine for endoscopic-guided orotracheal intubation in domestic rabbits (Oryctolagus cuniculus).
Cremer, J; da Cunha, A; Hampton, CE; Liu, CC; Nevarez, JG; Queiroz-Williams, P; Reabel, SN, 2021
)
0.62
"To explore the effects of low-dose dexmedetomidine (DM) combined with hydromorphone (HM) in postoperative analgesia and on levels of serum interleukin-6 (IL-6) and C-reactive protein (CRP) in PCa patients."( [Effects of low-dose dexmedetomidine combined with hydromorphone in postoperative analgesia and on the serum IL-6 and CRP levels of prostate cancer patients].
Gao, X; Gong, RJ; Li, YH; Xia, XQ; Yang, ZH; Yu, YB, 2021
)
0.62
"Low-dose dexmedetomidine combined with hydromorphone is a safe and effective option for postoperative analgesia in PCa patients, and it can inhibit the expression of inflammatory factors."( [Effects of low-dose dexmedetomidine combined with hydromorphone in postoperative analgesia and on the serum IL-6 and CRP levels of prostate cancer patients].
Gao, X; Gong, RJ; Li, YH; Xia, XQ; Yang, ZH; Yu, YB, 2021
)
0.62
"To evaluate the analgesic effect of butorphanol tartrate combined with hydromorphone on the patients with cesarean section, we conducted a prospective cohort study."( Analgesic effect of butorphanol tartrate combined with hydromorphone on patients with cesarean section: A prospective cohort study.
Gong, X; Xie, S; Zhang, G; Zhang, Y, 2022
)
0.72

Bioavailability

We evaluated pharmacokinetics and absolute bioavailability of single doses of hydromorphone hydrochloride after administration of 1.5mg/day. We also investigated the effect of the nasal corticosteroid fluticasone propionate on the bioavailability and pharmacokinetic of single-dose intranasal hydrom orphone hydro chloride in patients with allergic rhinitis.

ExcerptReferenceRelevance
" Plasma hydromorphone concentrations measured at 24 h and 48 h of infusion showed stable steady-state pharmacokinetics; the mean bioavailability from subcutaneous infusion was 78% of that with intravenous infusion."( Comparison of continuous subcutaneous and intravenous hydromorphone infusions for management of cancer pain.
Bouquillon, AI; Kreeft, JH; Moulin, DE; Murray-Parsons, N, 1991
)
0.28
"The absolute bioavailability of hydromorphone was investigated in eight healthy male subjects by a cross-over design (with washout period of two weeks) after intravenous (2 mg), peroral (4 mg) and rectal (3 mg) administration of hydromorphone."( Absolute bioavailability of hydromorphone after peroral and rectal administration in humans: saliva/plasma ratio and clinical effects.
Coyle, DE; Denson, DD; Gregg, RV; Parab, PV; Ritschel, WA, 1987
)
0.27
" The absolute bioavailability after peroral administration was 50."( Pharmacokinetics of hydromorphone after intravenous, peroral and rectal administration to human subjects.
Coyle, DE; Denson, DD; Gregg, RV; Parab, PV; Ritschel, WA,
)
0.13
" A plasma concentration-time curve from a subject administered a single oral dose of hydromorphone demonstrates the usefulness of the assay in monitoring drug levels in a bioavailability study."( Radioimmunoassay of hydromorphone and hydrocodone in human plasma.
Honigberg, IL; Stewart, JT, 1980
)
0.26
" Controlled-release hydromorphone demonstrated equivalent bioavailability and acceptable CR characteristics, when compared with IR hydromorphone (CR vs."( Steady-state pharmacokinetics of hydromorphone and hydromorphone-3-glucuronide in cancer patients after immediate and controlled-release hydromorphone.
Babul, N; Darke, AC; Dhaliwal, HS; Hagen, N; Harsanyi, Z; Thirlwell, MP, 1995
)
0.29
" Oral bioavailability is low."( Hydromorphone: pharmacology and clinical applications in cancer patients.
Nelson, KA; Sarhill, N; Walsh, D, 2001
)
0.31
" The increased bioavailability from the OROS formulation may be related to decreased metabolism by a first-pass effect or enterohepatic recycling of hydromorphone."( Input characteristics and bioavailability after administration of immediate and a new extended-release formulation of hydromorphone in healthy volunteers.
Angst, MS; Drover, DR; Naidu, S; Ramaswamy, B; Stanski, DR; Valle, M; Verotta, D, 2002
)
0.31
"Pharmacokinetics and bioavailability were determined for two doses of intranasal hydromorphone in healthy volunteers."( Pharmacokinetics and bioavailability of single-dose intranasal hydromorphone hydrochloride in healthy volunteers.
Archer, SM; Coda, BA; Rudy, AC; Wermeling, DP, 2003
)
0.32
"To investigate the effect of the nasal corticosteroid fluticasone propionate on the bioavailability and pharmacokinetics of single-dose intranasal hydromorphone hydrochloride in patients with allergic rhinitis."( Effect of fluticasone propionate nasal spray on bioavailability of intranasal hydromorphone hydrochloride in patients with allergic rhinitis.
Archer, SM; Davis, GA; McNamara, PJ; Rudy, AC; Wermeling, DP, 2004
)
0.32
" Mean (% coefficient of variation) absolute bioavailability of intranasal hydromorphone was 51."( Effect of fluticasone propionate nasal spray on bioavailability of intranasal hydromorphone hydrochloride in patients with allergic rhinitis.
Archer, SM; Davis, GA; McNamara, PJ; Rudy, AC; Wermeling, DP, 2004
)
0.32
" Study 1 investigated the bioavailability of 24-mg HHER fed, as well as 24-mg and 12-mg HHER and 8-mg hydromorphone hydrochloride immediate-release (HHIR) tablets fasting."( Clinical pharmacology and pharmacokinetics of once-daily hydromorphone hydrochloride extended-release capsules.
Cipriano, A; El-Tahtawy, A; Harris, S; Vashi, V; Wu, D, 2005
)
0.33
"Standard bioavailability measures show minimal effect of food on the bioavailability of hydromorphone from OROS hydromorphone."( Pharmacokinetic profile of a 24-hour controlled-release OROS formulation of hydromorphone in the presence and absence of food.
Gupta, SK; Sathyan, G; Thipphawong, J; Xu, E, 2007
)
0.34
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
" Though oral transmucosal fentanyl citrate has reduced bioavailability (25%), it inherits potential for breakthrough pain management."( Pediatric palliative care: use of opioids for the management of pain.
Anderson, BJ; Craig, F; Michel, E; Zernikow, B, 2009
)
0.35
" The bioavailability of hydromorphone from OROS hydromorphone is minimally affected by food or alcohol (ethanol)."( Use of hydromorphone, with particular reference to the OROS formulation, in the elderly.
Finco, G; Lussier, D; Richarz, U, 2010
)
0.36
" This study shows that the bioavailability of extended-release hydromorphone is not affected by food and that the bioavailability of extended-release hydromorphone under fasting conditions is comparable with that of the immediate-release formulation when administered at the same total daily dose."( A randomized study of the effects of food on the pharmacokinetics of once-daily extended-release hydromorphone in healthy volunteers.
Ariyawansa, J; Marricco, NC; Moore, KT; Morelli, G; Natarajan, J; Pagé, V; Richarz, U; St-Fleur, D, 2011
)
0.37
" This study characterized the bioavailability of these drugs following buccal administration to cats."( Bioavailability of morphine, methadone, hydromorphone, and oxymorphone following buccal administration in cats.
Ilkiw, JE; Pypendop, BH; Shilo-Benjamini, Y, 2014
)
0.4
"Results indicated hydromorphone hydrochloride had high bioavailability and rapid elimination after IM administration, with a short terminal half-life, rapid plasma clearance, and large volume of distribution in American kestrels."( Pharmacokinetics of hydromorphone hydrochloride after intravenous and intramuscular administration of a single dose to American kestrels (Falco sparverius).
Drazenovich, TL; Guzman, DS; KuKanich, B; Olsen, GH; Paul-Murphy, JR, 2014
)
0.4
" Median intramuscular bioavailability was 92% (range, 75% to 104%)."( Pharmacokinetics of hydromorphone after intravenous and intramuscular administration in male rhesus macaques (Macaca mulatta).
Christe, KL; Kelly, KR; Pypendop, BH, 2014
)
0.4
"Failure to recognize the impact of various situations described throughout this work, including the bioavailability due to loss of oral route, due to pharmacokinetics and pharmacodynamics of the various drugs, either in the context of the impaired metabolism or excretion, or in due to pharmacological interactions, conditions a serious risk of subtreatment of pain and consequent impact in terms of quality of life."( [Opioids for Cancer Pain and its Use under Particular Conditions: A Narrative Review].
Brás, M; Fragoso, M; Vieira, C, 2019
)
0.51
"IM hydromorphone has high bioavailability and provides a similar degree of antinociception to IV administration."( Pharmacokinetics and pharmacodynamics of hydromorphone after intravenous and intramuscular administration in horses.
Barletta, M; Knych, HK; Reed, RA; Ruch, MM; Ryan, CA; Sakai, DM; Smyth, CA, 2020
)
0.56
" Hydromorphone had high bioavailability after IM administration."( Pharmacokinetics of hydromorphone hydrochloride after intravenous and intramuscular administration in guinea pigs (
Ambros, B; Knych, HK; Sadar, MJ, 2020
)
0.56
" After IM administration, mean bioavailability was 97."( Pharmacokinetics of hydromorphone hydrochloride after intramuscular and intravenous administration of a single dose to orange-winged Amazon parrots (
Douglas, J; Knych, H; Paul-Murphy, JR; Sanchez-Migallon Guzman, D, 2020
)
0.56
"Hydromorphone hydrochloride had high bioavailability and rapid elimination after IM administration, with rapid plasma clearance and a large volume of distribution after IV administration in orange-winged Amazon parrots."( Pharmacokinetics of hydromorphone hydrochloride after intramuscular and intravenous administration of a single dose to orange-winged Amazon parrots (
Douglas, J; Knych, H; Paul-Murphy, JR; Sanchez-Migallon Guzman, D, 2020
)
0.56
"Hydromorphone had a high bioavailability of 170."( High bioavailability, short half-life, and metabolism into hydromorphone-3-glucuronide following single intramuscular and intravenous administration of hydromorphone hydrochloride to great horned owls (Bubo virginianus).
Hawkins, MG; Knych, HK; Sanchez-Migallon Guzman, D; Sosa-Higareda, M, 2023
)
0.91
" Hydromorphone rapidly attained plasma concentrations following IM administration and had high bioavailability and short t1/2."( High bioavailability, short half-life, and metabolism into hydromorphone-3-glucuronide following single intramuscular and intravenous administration of hydromorphone hydrochloride to great horned owls (Bubo virginianus).
Hawkins, MG; Knych, HK; Sanchez-Migallon Guzman, D; Sosa-Higareda, M, 2023
)
0.91

Dosage Studied

The short elimination half-life of hydromorphone necessitates 4-hourly dosing to maintain optimal levels of analgesia in patients with chronic cancer pain. Opioid choice was tightly linked with equianalgesic dose, with the median hydromOrphone dosage more than 50 percent higher than the dosage of morphine.

ExcerptRelevanceReference
" This study demonstrates the feasibility of well-controlled analgesic assays employing the double-dummy technique to compare suppositoreis with oral or parenteral analgesic dosage forms."( A comparison of the analgesic effect of oxymorphone by rectal suppository and intramuscular injection in patients with postoperative pain.
Beaver, WT; Feise, GA,
)
0.13
" The present protocol was designed to study the precision with which patients respond to minute changes in the level of a narcotic (hydromorphone) at the target site: this was achieved by varying in a double-blind fashion the amount of narcotic delivered in response to triggering the apparatus and noting how the patient adapts the dosing interval in response to the imposed changes."( Drugs or drums: what relieves postoperative pain?
Keeri-Szanto, M, 1979
)
0.26
"Patient selectivity, narcotic dosing requirements, discharge rate, patient preference for analgesic regimen, side effects, complications and cost-effectiveness."( Subcutaneous narcotic infusions for cancer pain: treatment outcome and guidelines for use.
Chester, MA; Geoghegan, MF; Goodwin, VA; Johnson, NG; Moulin, DE; Murray-Parsons, N, 1992
)
0.28
" A daily 8-mg SL dosage was sufficient to maintain individuals without producing reports of withdrawal symptoms."( Development of buprenorphine for the treatment of opioid dependence.
Fudala, PJ; Johnson, RE, 1992
)
0.28
" CI was always preceded by a period of repetitive dosing of opioids."( I.v. infusion of opioids for cancer pain: clinical review and guidelines for use.
Foley, KM; Inturrisi, CE; Moulin, DE; Portenoy, RK; Rogers, A, 1986
)
0.27
" There were significant differences between the two groups in pain score, patient assessment of analgesia quality, time to first analgesic intervention, and total dosage of hydromorphone during the first 24 hours."( Epidural hydromorphone for postcesarean analgesia.
Chestnut, DH; Choi, WW; Isbell, TJ, 1986
)
0.27
" The study was done in three phases: a training phase in which training drugs were identified to subjects by letter code before the session, a test of acquisition phase in which the subject's ability to identify the training drug by letter code was tested and a generalization phase in which dose-response curves for the two active training drugs were tested."( Three-choice drug discrimination in opioid-dependent humans: hydromorphone, naloxone and saline.
Bickel, W; Bigelow, GE; Liebson, IA; Preston, KL, 1987
)
0.27
" Dose-response curves at 1 hr revealed similar potencies of oxymorphone and the derivatives, with the exception of OxyPNPH which was significantly less potent."( Irreversible opiate agonists and antagonists. IV. Analgesic actions of 14-hydroxydihydromorphinone hydrazones.
Bodnar, RJ; Burks, TF; Clark, JE; Hahn, EF; Pasternak, GW; Williams, CL, 1988
)
0.27
" Physiologic measures and subject- and observer-rated behavioral responses were measured before dosing and for 120 min after drug administration."( Buprenorphine and naloxone alone and in combination in opioid-dependent humans.
Bigelow, GE; Liebson, IA; Preston, KL, 1988
)
0.27
" Physiologic measures and subject- and observer-rated behavioral responses were measured before dosing and for 2 hr after drug administration."( Butorphanol-precipitated withdrawal in opioid-dependent human volunteers.
Bigelow, GE; Liebson, IA; Preston, KL, 1988
)
0.27
" Knowing that there is a low concentration of narcotic in the blood of a patient with chronic severe pain who is receiving high drug doses and who shows lack of both efficacy and side effects may reassure health care professionals that further narcotic dosage escalation is appropriate."( Hydromorphone levels and pain control in patients with severe chronic pain.
Drayer, DE; Erle, H; Goodman, H; Gray, G; Leipzig, RM; Lorenzo, B; Meyer, BR; Reidenberg, MM, 1988
)
0.27
" Nalbuphine was not consistently identified as either pentazocine or hydromorphone and produced relatively flat dose-response functions on most of the subjective effect measures."( Drug discrimination in human postaddicts: agonist-antagonist opioids.
Bickel, WK; Bigelow, GE; Liebson, IA; Preston, KL, 1989
)
0.28
" Adverse reactions occurred more often with higher doses of morphine and codeine; the dose-response relationship could not be evaluated for the other three drugs."( Clinical effects of parenteral narcotics in hospitalized medical patients.
Miller, RR, 1980
)
0.26
" Although the patient gave no previous history of narcotic use or abuse, he required morphine dosing rates as high as 56 mg/h to maintain adequate analgesia."( Extraordinary analgesic requirement in a patient previously unexposed to narcotics.
Batenhorst, RL; Baumann, TJ; Bennett, RL; Foster, TS; Graves, DA; Griffen, WO; Plumlee, JE,
)
0.13
"The short elimination half-life of hydromorphone necessitates 4-hourly dosing to maintain optimal levels of analgesia in patients with chronic cancer pain."( Comparative clinical efficacy and safety of immediate release and controlled release hydromorphone for chronic severe cancer pain.
Babul, N; Darke, AC; Dhaliwal, H; Hagen, N; Harsanyi, Z; Hays, H; Thirlwell, M, 1994
)
0.29
" The authors conclude that CR hydromorphone provides a pharmacokinetic profile consistent with 12 hourly dosing and that at steady state, oral hydromorphone is extensively metabolized to H3G, although the pharmacologic activity of this metabolite remains unknown."( Steady-state pharmacokinetics of hydromorphone and hydromorphone-3-glucuronide in cancer patients after immediate and controlled-release hydromorphone.
Babul, N; Darke, AC; Dhaliwal, HS; Hagen, N; Harsanyi, Z; Thirlwell, MP, 1995
)
0.29
" These systems allowed bolus dosing and also provided a basic level of analgesic protection through continuous drug infusion."( Differences among patients in opioid self-administration during bone marrow transplantation.
Chapman, CR; Donaldson, GW; Hautman, B; Jacobson, RC, 1997
)
0.3
" The dosing of the narcotic analgesics incorporates seldom-used, but well-published pharmacokinetics."( Oral narcotic protocol to reduce narcotic injections in refractory migraine patients.
Adelman, JU; Von Seggern, RL, 1997
)
0.3
"7 for M/HM when rotating from HM to M in patients exposed to chronic dosing of these opioids."( Dose ratio between morphine and hydromorphone in patients with cancer pain: a retrospective study.
Bruera, E; Hanson, J; Lawlor, P; Turner, K, 1997
)
0.3
"Although methadone maintenance remains the best available treatment for opioid addiction, the need for daily oral dosing limits the effectiveness of methadone as opioid substitution therapy."( Hydromorphone polymer implant. A potential alternative to methadone maintenance.
Grossman, SA; Rhodes, DJ,
)
0.13
" Orderly dose-response functions suggested that our cumulative-dosing procedure is an efficient way of determining dose-response functions for multiple opioids within the same subjects within the same study."( Subjective, psychomotor, and physiological effects of cumulative doses of opioid mu agonists in healthy volunteers.
Walker, DJ; Zacny, JP, 1999
)
0.3
" Participants in the low-dose group exhibited a significant leftward shift in the dose-response function for discrimination performance, which is concordant with previous preclinical and human drug discrimination studies that assessed the effects of training dose."( Effects of training dose on the relationship between discriminative-stimulus and self-reported drug effects of d-amphetamine in humans.
Kollins, SH; Rush, CR, 1999
)
0.3
" Dosing was double-blind and double-dummy."( Effects of buprenorphine versus buprenorphine/naloxone tablets in non-dependent opioid abusers.
Bigelow, GE; Stoller, K; Strain, EC; Walsh, SL, 2000
)
0.31
" Pentazocine produced an inverted U-shaped dose-response curve with complete substitution at 32 mg/70 kg but not at 64 mg/70 kg."( Effects of agonist-antagonist opioids in humans trained in a hydromorphone/not hydromorphone discrimination.
Bigelow, GE; Preston, KL, 2000
)
0.31
" However, the dose-response functions for opioid agonists are complex in that low doses increase ethanol self-administration, whereas moderate to high doses decrease ethanol self-administration."( Pretreatment with hydromorphone, a mu-opioid agonist, does not alter the acute behavioral and physiological effects of ethanol in humans.
Rush, CR, 2001
)
0.31
" As the surgical wound was being closed, the catheters were dosed with fentanyl and hydromorphone followed by a continuous infusion of ropivacaine plus hydromorphone."( A dual epidural catheter technique to provide analgesia following posterior spinal fusion for scoliosis in children and adolescents.
Bildner, C; Gaines, RW; Kittle, D; Lowry, KJ; Tobias, JD, 2001
)
0.31
" Test sessions were twice per week; dosing was double-blind."( Effects of buprenorphine/naloxone in opioid-dependent humans.
Bigelow, GE; Stoller, KB; Strain, EC; Walsh, SL, 2001
)
0.31
"To present the authors' technique for epidural catheter placement and dosing protocol, and to demonstrate the results from postoperative pain control after anterior spinal instrumented fusion for 10 consecutive patients."( Postoperative pain control using epidural catheters after anterior spinal fusion for adolescent scoliosis.
Burd, T; Gaines, RW; Kittle, D; Lowry, KJ; Tobias, J, 2001
)
0.31
" The authors believe that this lack of consensus stems from varied epidural dosing protocols and techniques in catheter placement, which they have witnessed anecdotally at their own institution."( Postoperative pain control using epidural catheters after anterior spinal fusion for adolescent scoliosis.
Burd, T; Gaines, RW; Kittle, D; Lowry, KJ; Tobias, J, 2001
)
0.31
" Dosing consisted of fentanyl (1 microg/kg) and hydromorphone (5 microg/kg) diluted in preservative-free saline (0."( Postoperative pain control using epidural catheters after anterior spinal fusion for adolescent scoliosis.
Burd, T; Gaines, RW; Kittle, D; Lowry, KJ; Tobias, J, 2001
)
0.31
"By following the dosing protocol described, epidural catheters can be used safely and effectively to control postoperative pain after anterior instrumentation and spinal fusion for adolescent scoliosis."( Postoperative pain control using epidural catheters after anterior spinal fusion for adolescent scoliosis.
Burd, T; Gaines, RW; Kittle, D; Lowry, KJ; Tobias, J, 2001
)
0.31
" Thus, our data clearly imply that if H3G crosses the BBB with equivalent efficiency to M3G, then the myoclonus, allodynia and seizures observed in some patients dosed chronically with large systemic doses of HMOR, are almost certainly due to the accumulation of sufficient H3G in the central nervous system, to evoke behavioural excitation."( Hydromorphone-3-glucuronide: a more potent neuro-excitant than its structural analogue, morphine-3-glucuronide.
Mather, LE; Smith, MT; Wright, AW, 2001
)
0.31
" Examples for calculating required drug dosage depending on the clinical situation and the route of administration."( [New Level III opioids of the World Health Organization].
Laval, G; Mallaret, M; Sang, B; Villard, ML, 2002
)
0.31
"To test the opioid blockade efficacy of sublingual buprenorphine/naloxone versus buprenorphine alone and determine whether: (1) the blockade efficacy of buprenorphine/naloxone varies between the time of expected maximal and minimal effects of naloxone, (2) the blockade efficacy of buprenorphine/naloxone and buprenorphine varies as a function of maintenance dose level, and (3) there are adaptive changes over time associated with repeated daily dosing of buprenorphine/naloxone and buprenorphine."( Blockade of hydromorphone effects by buprenorphine/naloxone and buprenorphine.
Bigelow, GE; Strain, EC; Walsh, SL, 2002
)
0.31
" Changes over time associated with repeated daily dosing of buprenorphine/naloxone and buprenorphine were minimal."( Blockade of hydromorphone effects by buprenorphine/naloxone and buprenorphine.
Bigelow, GE; Strain, EC; Walsh, SL, 2002
)
0.31
" C(ssmax) was 26% lower for HHER than HHIR, C(ssmin) was 43% higher for HHER, and peak-to-trough fluctuation was 126% for HHER versus 328% for HHIR, which are ideal attributes of a once-daily oral extended-release dosage form."( Clinical pharmacology and pharmacokinetics of once-daily hydromorphone hydrochloride extended-release capsules.
Cipriano, A; El-Tahtawy, A; Harris, S; Vashi, V; Wu, D, 2005
)
0.33
"Two multicenter, randomized, double-blind, crossover studies with identical designs evaluated the efficacy of oral extended-release hydromorphone (HHER) administered q24h compared with immediate-release hydromorphone (HHIR) dosed four times daily in patients with persistent moderate to severe pain."( Comparative efficacy of oral extended-release hydromorphone and immediate-release hydromorphone in patients with persistent moderate to severe pain: two randomized controlled trials.
Buckley, BJ; Grosset, AB; Reder, RF; Roberts, MS; Shi, M; Swanton, RE; Woodson, ME, 2005
)
0.33
" Intrathecal drug delivery systems can be highly effective in a variety of patient settings, including cases of refractory pain, diminished performance status, poor tolerability of oral medications, polyanalgesia for complex pain, and inadequate dosing due to addiction concerns."( Intrathecal drug delivery for the management of cancer pain: a multidisciplinary consensus of best clinical practices.
Boortz-Marx, R; Du Pen, S; Friehs, G; Gordon, M; Halyard, M; Herbst, L; Kiser, J; Stearns, L,
)
0.13
"Buprenorphine has a long duration of action that allows less than daily dosing for opioid dependence, but pharmacologic characterization of buprenorphine's duration of effects over multiple days is incomplete."( Effects associated with double-blind omission of buprenorphine/naloxone over a 98-h period.
Bigelow, GE; Correia, CJ; Strain, EC; Walsh, SL, 2006
)
0.33
"Plasma samples taken predose and at regular intervals up to 48 h after dosing were assayed for hydromorphone concentrations; a mixed-effect analysis of variance was done on log-transformed data."( Pharmacokinetic profile of a 24-hour controlled-release OROS formulation of hydromorphone in the presence of alcohol.
Sathyan, G; Sivakumar, K; Thipphawong, J, 2008
)
0.35
"Plasma hydromorphone concentrations were slightly higher after dosing with all alcohol treatments in both the fasted and fed subject groups."( Pharmacokinetic profile of a 24-hour controlled-release OROS formulation of hydromorphone in the presence of alcohol.
Sathyan, G; Sivakumar, K; Thipphawong, J, 2008
)
0.35
" This review focuses on the use of hydromorphone for the management of cancer-related pain emphasizing on the various routes of administration as well as dosage forms, and providing a direction for the preference of a particular route depending on the need for a rapid effect and the individual's situation."( Hydromorphone in the management of cancer-related pain: an update on routes of administration and dosage forms.
Kumar, MG; Lin, S, 2007
)
0.34
"Hydromorphone has a short half-life, suggesting that frequent dosing intervals are needed."( Pharmacokinetics of hydromorphone hydrochloride in healthy dogs.
Hogan, BK; Krugner-Higby, LA; KuKanich, B; Smith, LJ, 2008
)
0.35
" hydromorphone's time of peak analgesic (tail-flick) effect (45 min) and ED50 using standard and cumulative dosing protocols (0."( Hydromorphone efficacy and treatment protocol impact on tolerance and mu-opioid receptor regulation.
Dighe, SV; Kumar, P; Sirohi, S; Sunkaraneni, S; Walker, EA; Yoburn, BC, 2008
)
0.35
" HM resulted in > 65 percent reduction in pain over dosing intervals."( Pain management in chronic kidney disease: the pharmacokinetics and pharmacodynamics of hydromorphone and hydromorphone-3-glucuronide in hemodialysis patients.
Davison, SN; Mayo, PR,
)
0.13
"To assess the safety and efficacy of long-term repeated dosing of OROS hydromorphone in chronic pain patients."( Long-term safety, tolerability, and efficacy of OROS hydromorphone in patients with chronic pain.
Khanna, S; Moulin, DE; Rauck, RL; Skowronski, R; Thipphawong, J; Tudor, IC; Wallace, M,
)
0.13
" This study provides an excellent platform on which to build future trials that could include increased baseline dosing for the epidural medications, radiographic confirmation of catheter placement, and dual catheter techniques toward the goal of improving pain control in these patients."( Epidural analgesia compared with intravenous analgesia after pediatric posterior spinal fusion.
Burke, CN; Caird, MS; Farley, FA; Gauger, VT; Kostrzewa, AJ; Voepel-Lewis, TD; Wagner, DS, 2009
)
0.35
" OROS hydromorphone (Jurnista, Janssen Pharmaceuticals, NV, Beerse, Belgium) releases hydromorphone over a 24-hour dosing period."( The role of OROS hydromorphone in the management of cancer pain.
Gardner-Nix, J; Mercadante, S,
)
0.13
" This study sought to (1) describe the variability in intravenous opioid dosing and (2) compare the outcomes that result from the most commonly prescribed opioid doses."( Intravenous opioid dosing and outcomes in emergency patients: a prospective cohort analysis.
Feng, C; Hays, DP; O'Connor, AB; Zwemer, FL, 2010
)
0.36
"We found marked opioid dosing variability and infrequent opioid dose titration."( Intravenous opioid dosing and outcomes in emergency patients: a prospective cohort analysis.
Feng, C; Hays, DP; O'Connor, AB; Zwemer, FL, 2010
)
0.36
" In chronic pain management, OROS® products can result in more stable drug concentrations, reduced dosing frequency and an improved safety profile."( OROS® hydromorphone in chronic pain management: when drug delivery technology matches clinical needs.
Coluzzi, F; Mattia, C, 2010
)
0.36
" Dosage adjustment is recommended in patients with moderate hepatic impairment (Child-Pugh class B) and moderate renal impairment (creatinine clearance of 30-60 mL/min)."( Oral hydromorphone extended-release.
Guay, DR, 2010
)
0.36
" It also enabled a reduction in the intrathecal opioid dosage leading to a resolution of the acute symptoms attributed to OIH."( Successful reversal of hyperalgesia/myoclonus complex with low-dose ketamine infusion.
Chan, PS; Forero, M; Restrepo-Garces, CE, 2012
)
0.38
"Opioid analgesics administered by patient-controlled analgesia (PCA)are frequently used for pain relief in children and adults with sickle cell disease (SCD) hospitalized for persistent vaso-occlusive pain, but optimum opioid dosing is not known."( Opioid patient controlled analgesia use during the initial experience with the IMPROVE PCA trial: a phase III analgesic trial for hospitalized sickle cell patients with painful episodes.
Bell, MC; Dampier, CD; Hsu, L; Keefer, J; Kim, HY; Krishnamurti, L; Mack, AK; McClish, D; McKinlay, SM; Miller, ST; Minniti, CP; Osunkwo, I; Seaman, P; Smith, WR; Telen, MJ; Wager, CG; Weiner, DL, 2011
)
0.37
" A critical element to this approach involved providing sufficient immediate-release opioid to treat breakthrough pain and to reverse acute abstinence signs and symptoms if the dosing changes prove insufficient."( Overdose deaths demand a new paradigm for opioid rotation.
Fine, PG; Webster, LR, 2012
)
0.38
"" Global assessments of efficacy, dosing convenience, and tolerability were secondary endpoints."( Sustained safety and efficacy of once-daily hydromorphone extended-release (OROS® hydromorphone ER) compared with twice-daily oxycodone controlled-release over 52 weeks in patients with moderate to severe chronic noncancer pain.
Binsfeld, H; Richarz, U; Sabatowski, R; Szczepanski, L; Waechter, S, 2013
)
0.39
"To describe dosing regimens and efficacy of continuous infusion hydromorphone in mechanically ventilated children."( Continuous hydromorphone for pain and sedation in mechanically ventilated infants and children.
Dobyns, EL; Ng, J; Reiter, PD,
)
0.13
"Hydromorphone dosing requirements, concomitant pain and sedation therapy, patient-specific pain scores (using Face Legs Activity Cry Consolability [FLACC] pain scale), and possible adverse drug events related to therapy."( Continuous hydromorphone for pain and sedation in mechanically ventilated infants and children.
Dobyns, EL; Ng, J; Reiter, PD,
)
0.13
" These results suggest that administration of NSAIDs into surgical wounds may be an analgesic alternative to higher systemic dosing of NSAIDs."( Postoperative subcutaneous instillation of low-dose ketorolac but not hydromorphone reduces wound exudate concentrations of interleukin-6 and interleukin-10 and improves analgesia following cesarean delivery.
Angst, MS; Carvalho, B; Lemmens, HJ; Ting, V, 2013
)
0.39
"Safety results were pooled from 13 controlled and uncontrolled clinical studies, with varying approaches to dosing and titration, pain etiology, and duration of exposure."( Safety and tolerability of OROS® hydromorphone ER in adults with chronic noncancer and cancer pain: pooled analysis of 13 studies.
Hale, ME; Kutch, M; Nalamachu, S; Taylor, DR; Wallace, MS,
)
0.13
"Opioid choice was tightly linked with equianalgesic dose, with the median hydromorphone dosage more than 50 percent higher than the dosage of morphine."( Why do emergency providers choose one opioid over another? A prospective cohort analysis.
O'Connor, AB; Rao, A,
)
0.13
"Patients were converted from previous opioid therapy to OROS hydromorphone ER using a 5:1 morphine:hydromorphone equianalgesic dosing ratio, with an initial 50 percent reduction of the calculated equianalgesic dose, titrated every 3-4 days to adequate analgesia over 2 weeks."( Open-label study to evaluate the efficacy and safety of extended-release hydromorphone in patients with chronic neuropathic pain.
Bansal, R; Fasbinder, S; Nalamachu, S; Nalamasu, R; Ruck, D,
)
0.13
" The application of this patient-derived population model in individualized pain therapy should improve the dosing of hydromorphone in patients undergoing cardiac surgery."( Population pharmacokinetic modeling of hydromorphone in cardiac surgery patients during postoperative pain therapy.
Fechner, J; Fröhlich, K; Ihmsen, H; Jeleazcov, C; Krajinovic, L; Mell, J; Saari, TI; Schüttler, J, 2014
)
0.4
" Following intrathecal administration, norhydrocodone produced a shallow analgesia dose-response curve and maximal effect of 15-45%, whereas hydrocodone and hydromorphone produced dose-dependent analgesia."( In vivo activity of norhydrocodone: an active metabolite of hydrocodone.
Navani, DM; Yoburn, BC, 2013
)
0.39
"It remains unknown whether initial opioid dosing should optimally be fixed or weight-based."( Does initial hydromorphone relieve pain best if dosing is fixed or weight based?
Birnbaum, A; Choe, D; Hernandez, L; Xia, S, 2014
)
0.4
" Dosage and side effects were recorded at each visit."( Long-term efficacy of OROS® hydromorphone combined with pregabalin for chronic non-cancer neuropathic pain.
Casali, M; Dauri, M; Lazzari, M; Sabato, AF; Sabato, E; Tufaro, G, 2014
)
0.4
" Thus, a treatment option with the potential for a reduced dosing frequency exists for health care providers and patients."( Safety and efficacy of once-daily hydromorphone extended-release versus twice-daily oxycodone hydrochloride controlled-release in chinese patients with cancer pain: a phase 3, randomized, double-blind, multicenter study.
Han, J; Hou, Y; Richards, HM; Shen, W; Yu, L; Yu, S, 2014
)
0.4
"Sufentanil protein binding was significantly dependent on changes in the total drug concentration and volume balance addressing the importance of adequate dosing and fluid-guided therapy."( Influence of intensive care treatment on the protein binding of sufentanil and hydromorphone during pain therapy in postoperative cardiac surgery patients.
Fechner, J; Fröhlich, K; Ihmsen, H; Jeleazcov, C; Mell, J; Saari, TI; Schüttler, J, 2014
)
0.4
"To investigate effects of extended-release (ER) hydromorphone dosing time (morning, QAM; evening, QPM) on sleep physiology in patients with chronic low back pain."( Comparative effects of morning vs. evening dosing of extended-release hydromorphone on sleep physiology in patients with low back pain: a pilot study.
Iverson, M; Mackin, S; Smith, MD; Webster, LR, 2015
)
0.42
" Overnight polysomnographic sleep studies were performed at baseline, following IR hydromorphone titration, and following each ER hydromorphone dosing period."( Comparative effects of morning vs. evening dosing of extended-release hydromorphone on sleep physiology in patients with low back pain: a pilot study.
Iverson, M; Mackin, S; Smith, MD; Webster, LR, 2015
)
0.42
" Secondarily, QAM dosing resulted in numerically fewer apnea episodes and improvements in pulse oximetry measures; however, these differences were not significant (P > 0."( Comparative effects of morning vs. evening dosing of extended-release hydromorphone on sleep physiology in patients with low back pain: a pilot study.
Iverson, M; Mackin, S; Smith, MD; Webster, LR, 2015
)
0.42
"ER hydromorphone QAM dosing may be preferred if sleep-disordered breathing associated with ongoing opioid therapy is of concern; however, QPM dosing may be advantageous in terms of pain relief and quality/quantity of sleep."( Comparative effects of morning vs. evening dosing of extended-release hydromorphone on sleep physiology in patients with low back pain: a pilot study.
Iverson, M; Mackin, S; Smith, MD; Webster, LR, 2015
)
0.42
"To evaluate the effect of dosing interval on the efficacy of maropitant for prevention of opioid-induced vomiting and signs of nausea in dogs."( Effect of dosing interval on efficacy of maropitant for prevention of hydromorphone-induced vomiting and signs of nausea in dogs.
Hay Kraus, BL, 2014
)
0.4
" However, signs of nausea were significantly decreased only when the dosing interval was 60 minutes."( Effect of dosing interval on efficacy of maropitant for prevention of hydromorphone-induced vomiting and signs of nausea in dogs.
Hay Kraus, BL, 2014
)
0.4
" Mean daily morphine equivalent dosing decreased from 805."( Prospective Observational Study of Patient-Controlled Intrathecal Analgesia: Impact on Cancer-Associated Symptoms, Breakthrough Pain Control, and Patient Satisfaction.
Brogan, SE; Okifuji, A; Winter, NB,
)
0.13
"In this study, the coadministration of single-dose HYD with paroxetine at steady state did not alter systemic exposure to hydrocodone, suggesting that HYD can be coadministered with CYP2D6 inhibitors at therapeutic doses, without dosage modification."( Effects of paroxetine, a CYP2D6 inhibitor, on the pharmacokinetic properties of hydrocodone after coadministration with a single-entity, once-daily, extended-release hydrocodone tablet.
Cipriano, A; Friedman, K; Harris, SC; Kapil, RP; Michels, G; Mondal, SA; Shet, M, 2015
)
0.42
" Predefined subgroup analyses and meta-regression did not detect significant differences across subgroups, including a dose-response relationship."( Ketamine added to morphine or hydromorphone patient-controlled analgesia for acute postoperative pain in adults: a systematic review and meta-analysis of randomized trials.
Cheng, D; Johnston, B; Kaushal, A; Martin, J; Wang, L; Zhu, F, 2016
)
0.43
" Opioids were not dosed in an equipotent manner."( The Changing Use of Intravenous Opioids in an Emergency Department.
Albertson, TE; Chenoweth, JA; Clarke, SO; Gutierrez, R; Roche, BM; Sutter, ME; Wintemute, GJ, 2015
)
0.42
" The JCAHO program likely was at least indirectly responsible for this change in relative dosing of the opioids."( The Changing Use of Intravenous Opioids in an Emergency Department.
Albertson, TE; Chenoweth, JA; Clarke, SO; Gutierrez, R; Roche, BM; Sutter, ME; Wintemute, GJ, 2015
)
0.42
" Stable subjects were dosed intravenously on 5 consecutive days."( Abuse deterrence testing: A dose ratio escalation study examining naloxone coadministered with intravenous hydromorphone in non-treatment-seeking, opioid-dependent drug users.
Chakaraborty, B; Geoffroy, P; Levy-Cooperman, N; Michalko, KJ; Reiz, JL; Schoedel, KA; Thompson, D,
)
0.13
"Ten of 20 participants reported an effective hydromorphone dosage 12h post-injection."( Determination of ED
Lynde, GC, 2016
)
0.43
" With the dosing used in our study, analgesia from morphine lasted longer than hydromorphone via intrathecal and epidural routes; however, neuraxial hydromorphone remains a reasonable option for long-acting analgesia post cesarean delivery."( Neuraxial opioids for post-cesarean delivery analgesia: can hydromorphone replace morphine? A retrospective study.
Balofsky, A; Edwards, K; Feng, C; Iqbal, A; Jackson, M; Kanel, J; Marroquin, B; Newton, M; Rothstein, D; Wissler, R; Wong, E, 2017
)
0.46
"When injectable hydromorphone and diacetylmorphine are individually dosed and monitored, their opioid-related side effects, including potential fatal overdoses, are safely mitigated and treated by health care providers."( Safety profile of injectable hydromorphone and diacetylmorphine for long-term severe opioid use disorder.
Anis, AH; Brissette, S; Guh, D; Harrison, S; Janmohamed, A; Jutha, S; Krausz, M; MacDonald, S; Marchand, K; Marsh, DC; Oviedo-Joekes, E; Schechter, MT; Zhang, DZ, 2017
)
0.46
" There are advantages and disadvantages in using these 2 opioids which are discussed, and potential dosing strategies are outlined."( What Parenteral Opioids to Use in Face of Shortages of Morphine, Hydromorphone, and Fentanyl.
Behm, B; Davis, MP; Fernandez, C; McPherson, ML; Mehta, Z, 2018
)
0.48
" In major inpatient surgery, intraoperative single-dose methadone produces better analgesia and reduces opioid use compared with conventional repeated dosing of short-duration opioids."( Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study.
Blood, J; Brunt, LM; Deych, E; Kharasch, ED; Komen, H, 2019
)
0.51
"15 mg/kg ideal body weight) or conventional as-needed dosing of short-duration opioids (eg, fentanyl, hydromorphone; controls)."( Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study.
Blood, J; Brunt, LM; Deych, E; Kharasch, ED; Komen, H, 2019
)
0.51
" Discharge prescription in morphine milligram equivalents (MMEs, a standardized dosing unit that allows for comparison across opioid types) was calculated."( Prescription Opioid Type and the Likelihood of Prolonged Opioid Use After Orthopaedic Surgery.
Basilico, M; Bhashyam, AR; Harris, MB; Heng, M, 2019
)
0.51
" Each session used a cumulative dosing design with four IV injections (4, 4, 8, and 16 mg of hydromorphone or 4, 4, 8, and 16 mg of buprenorphine); quantitative sensory testing and abuse liability assessments were measured at baseline and after each injection."( Analgesic Effects of Hydromorphone versus Buprenorphine in Buprenorphine-maintained Individuals.
Bigelow, GE; Edwards, RR; Huhn, AS; Smith, MT; Strain, EC; Tompkins, DA, 2019
)
0.51
"To determine pharmacokinetic dosing strategy in bearded dragons (Pogona vitticeps) and red-eared sliders (Trachemys scripta elegans) based on two subcutaneously (SC) administered doses of hydromorphone (0."( Pharmacokinetics of subcutaneously administered hydromorphone in bearded dragons (Pogona vitticeps) and red-eared slider turtles (Trachemys scripta elegans).
Cox, S; Hawkins, SJ; Sladky, K; Yaw, TJ, 2019
)
0.51
" Due to lack of data, pediatric dosing (based on adult pharmacokinetic models) is not optimal."( Hydromorphone population pharmacokinetics in pediatric surgical patients.
Balyan, R; Chidambaran, V; Dong, M; Geisler, K; Pilipenko, V; Vinks, AA, 2020
)
0.56
" To identify optimal patient-controlled analgesia dosing parameters, we simulated several initial loading doses, demand doses, and lockout intervals."( Hydromorphone population pharmacokinetics in pediatric surgical patients.
Balyan, R; Chidambaran, V; Dong, M; Geisler, K; Pilipenko, V; Vinks, AA, 2020
)
0.56
"The optimal dosing of post-operative total knee arthroplasty (TKA) narcotics is unclear."( Average narcotic usage in a group of TKA patients following a modern TKA protocol.
Chapman, DM; Costales, TG; Dalury, DF; Greenwell, PH; Volkmann, MC, 2021
)
0.62
" Linear mixed models were used to determine if the mean cumulative opioid/sedative dosing differed from the day of conversion versus three 24-hour periods prior to conversion."( Conversion From Continuous Infusion Fentanyl to Continuous Infusion Hydromorphone in the Pediatric Intensive Care Unit.
Harkin, M; Johnson, PN; Lim, SY; Miller, JL; Neely, SB; Walsh, CK, 2021
)
0.62
" Patients had a significant decrease in opioid dosing on the day of conversion versus the 24-hour period prior to conversion but no changes in sedative dosing following conversion."( Conversion From Continuous Infusion Fentanyl to Continuous Infusion Hydromorphone in the Pediatric Intensive Care Unit.
Harkin, M; Johnson, PN; Lim, SY; Miller, JL; Neely, SB; Walsh, CK, 2021
)
0.62
" Incorrect narcotic dosing (44%), and narcotic count discrepancies (27%) were most commonly reported with active failures being the most commonly reported contributory factors such as failure to review medication orders prior to narcotic administration."( Threats to Narcotic Safety-A Narrative Review of Narcotic Incidents, Discrepancies and Near-Misses Within a Large Canadian Health System.
Bailey, C; Jeffs, L, 2022
)
0.72
"Patients with persistent severe cancer pain (≥7 at rest on the 11-point numeric rating scale [NRS]) were randomly assigned to 1 of 3 treatment arms: (A1) IPCA hydromorphone with bolus-only dose where dosage was 10% to 20% of the total equianalgesic over the previous 24 hours (TEOP24H) administered as needed, (A2) IPCA hydromorphone with continuous infusion where dose per hour was the TEOP24H divided by 24 and bolus dosage for breakthrough pain was 10% to 20% of the TEOP24H, and (B) oral extended-release morphine based on TEOP24H/2 × 75% (because of incomplete cross-tolerance) every 12 hours plus normal-release morphine based on TEOP24H × 10% to 20% for breakthrough pain."( Intravenous Patient-Controlled Analgesia Versus Oral Opioid to Maintain Analgesia for Severe Cancer Pain: A Randomized Phase II Trial.
Chen, H; Huang, C; Li, X; Lin, R; Lin, S; Liu, J; Lu, M; Luo, Y; Lv, X; Su, L; Wu, M; Zhang, Z; Zhao, S; Zhou, M; Zhu, J; Zou, H, 2022
)
0.72
" Both exposures were also associated with a reduced probability and reduced total dosage of opioid administration in the PACU."( Association of Intraoperative Opioid Administration With Postoperative Pain and Opioid Use.
Balanza, G; Bharadwaj, KM; Bittner, EA; Das, P; Deng, H; Gutierrez, R; Horgan, C; Houle, TT; Johnson, JJ; Liu, R; Macdonald, T; Pandit, A; Purdon, PL; Santa Cruz Mercado, LA; Stone, TAD; Tou, SLJ, 2023
)
0.91
"Optimal intrathecal dosing regimens for hydromorphone are not well established for analgesia after abdominal surgery."( Retrospective Review of Intrathecal Hydromorphone Dose Range and Complications.
Charnin, JE; Nuttall, GA; Portner, ER; Schroeder, DR; Sviggum, HP; Weingarten, TN, 2023
)
0.91
"We reviewed intrathecal hydromorphone doses and complications because dosing variability has been observed among anesthesiologists."( Retrospective Review of Intrathecal Hydromorphone Dose Range and Complications.
Charnin, JE; Nuttall, GA; Portner, ER; Schroeder, DR; Sviggum, HP; Weingarten, TN, 2023
)
0.91
" Patients were categorized into 3 hydromorphone dosing groups: low-dose (50-100 µg), middle-dose (101-199 µg), and high-dose (200-300 µg)."( Retrospective Review of Intrathecal Hydromorphone Dose Range and Complications.
Charnin, JE; Nuttall, GA; Portner, ER; Schroeder, DR; Sviggum, HP; Weingarten, TN, 2023
)
0.91
" Higher rates of severe opioid-related events were detected for patients receiving high-dose hydromorphone in the PACU, but all other safety outcomes were similar between dosing regimens."( Retrospective Review of Intrathecal Hydromorphone Dose Range and Complications.
Charnin, JE; Nuttall, GA; Portner, ER; Schroeder, DR; Sviggum, HP; Weingarten, TN, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
opioid analgesicA narcotic or opioid substance, synthetic or semisynthetic agent producing profound analgesia, drowsiness, and changes in mood.
mu-opioid receptor agonistA compound that exhibits agonist activity at the mu-opioid receptor.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (2)

ClassDescription
morphinane alkaloidAn isoquinoline alkaloid based on a morphinan skeleton and its substituted derivatives.
organic heteropentacyclic compound
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (1)

PathwayProteinsCompounds
Hydromorphone Action Pathway3111

Protein Targets (5)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Solute carrier family 22 member 1 Homo sapiens (human)IC50 (µMol)137.97000.21005.553710.0000AID1526751
Mu-type opioid receptorHomo sapiens (human)Ki0.00030.00000.419710.0000AID416813
Delta-type opioid receptorHomo sapiens (human)Ki0.03800.00000.59789.9300AID416814
Kappa-type opioid receptorHomo sapiens (human)Ki0.00280.00000.362410.0000AID416815
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Mu-type opioid receptorHomo sapiens (human)EC50 (µMol)0.00260.00000.32639.4000AID417156
Kappa-type opioid receptorHomo sapiens (human)EC50 (µMol)0.01100.00000.22448.9900AID417160
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Solute carrier family 22 member 1 Homo sapiens (human)Km56.10000.47704.03089.0000AID1526737
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (89)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processSolute carrier family 22 member 1 Homo sapiens (human)
neurotransmitter transportSolute carrier family 22 member 1 Homo sapiens (human)
serotonin transportSolute carrier family 22 member 1 Homo sapiens (human)
establishment or maintenance of transmembrane electrochemical gradientSolute carrier family 22 member 1 Homo sapiens (human)
organic cation transportSolute carrier family 22 member 1 Homo sapiens (human)
quaternary ammonium group transportSolute carrier family 22 member 1 Homo sapiens (human)
prostaglandin transportSolute carrier family 22 member 1 Homo sapiens (human)
monoamine transportSolute carrier family 22 member 1 Homo sapiens (human)
putrescine transportSolute carrier family 22 member 1 Homo sapiens (human)
spermidine transportSolute carrier family 22 member 1 Homo sapiens (human)
acetylcholine transportSolute carrier family 22 member 1 Homo sapiens (human)
dopamine transportSolute carrier family 22 member 1 Homo sapiens (human)
norepinephrine transportSolute carrier family 22 member 1 Homo sapiens (human)
thiamine transportSolute carrier family 22 member 1 Homo sapiens (human)
xenobiotic transportSolute carrier family 22 member 1 Homo sapiens (human)
epinephrine transportSolute carrier family 22 member 1 Homo sapiens (human)
serotonin uptakeSolute carrier family 22 member 1 Homo sapiens (human)
norepinephrine uptakeSolute carrier family 22 member 1 Homo sapiens (human)
thiamine transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
metanephric proximal tubule developmentSolute carrier family 22 member 1 Homo sapiens (human)
purine-containing compound transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
dopamine uptakeSolute carrier family 22 member 1 Homo sapiens (human)
monoatomic cation transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
transport across blood-brain barrierSolute carrier family 22 member 1 Homo sapiens (human)
(R)-carnitine transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
acyl carnitine transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
spermidine transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
cellular detoxificationSolute carrier family 22 member 1 Homo sapiens (human)
xenobiotic transport across blood-brain barrierSolute carrier family 22 member 1 Homo sapiens (human)
histamine metabolic processSolute carrier family 22 member 3Homo sapiens (human)
organic cation transportSolute carrier family 22 member 3Homo sapiens (human)
quaternary ammonium group transportSolute carrier family 22 member 3Homo sapiens (human)
monoatomic ion transportSolute carrier family 22 member 3Homo sapiens (human)
neurotransmitter transportSolute carrier family 22 member 3Homo sapiens (human)
serotonin transportSolute carrier family 22 member 3Homo sapiens (human)
organic cation transportSolute carrier family 22 member 3Homo sapiens (human)
quaternary ammonium group transportSolute carrier family 22 member 3Homo sapiens (human)
organic anion transportSolute carrier family 22 member 3Homo sapiens (human)
monocarboxylic acid transportSolute carrier family 22 member 3Homo sapiens (human)
monoamine transportSolute carrier family 22 member 3Homo sapiens (human)
spermidine transportSolute carrier family 22 member 3Homo sapiens (human)
dopamine transportSolute carrier family 22 member 3Homo sapiens (human)
norepinephrine transportSolute carrier family 22 member 3Homo sapiens (human)
regulation of appetiteSolute carrier family 22 member 3Homo sapiens (human)
xenobiotic transportSolute carrier family 22 member 3Homo sapiens (human)
epinephrine transportSolute carrier family 22 member 3Homo sapiens (human)
histamine transportSolute carrier family 22 member 3Homo sapiens (human)
serotonin uptakeSolute carrier family 22 member 3Homo sapiens (human)
histamine uptakeSolute carrier family 22 member 3Homo sapiens (human)
norepinephrine uptakeSolute carrier family 22 member 3Homo sapiens (human)
epinephrine uptakeSolute carrier family 22 member 3Homo sapiens (human)
purine-containing compound transmembrane transportSolute carrier family 22 member 3Homo sapiens (human)
dopamine uptakeSolute carrier family 22 member 3Homo sapiens (human)
transport across blood-brain barrierSolute carrier family 22 member 3Homo sapiens (human)
spermidine transmembrane transportSolute carrier family 22 member 3Homo sapiens (human)
cellular detoxificationSolute carrier family 22 member 3Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMu-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMu-type opioid receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayMu-type opioid receptorHomo sapiens (human)
sensory perceptionMu-type opioid receptorHomo sapiens (human)
negative regulation of cell population proliferationMu-type opioid receptorHomo sapiens (human)
sensory perception of painMu-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor signaling pathwayMu-type opioid receptorHomo sapiens (human)
behavioral response to ethanolMu-type opioid receptorHomo sapiens (human)
positive regulation of neurogenesisMu-type opioid receptorHomo sapiens (human)
negative regulation of Wnt protein secretionMu-type opioid receptorHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeMu-type opioid receptorHomo sapiens (human)
calcium ion transmembrane transportMu-type opioid receptorHomo sapiens (human)
cellular response to morphineMu-type opioid receptorHomo sapiens (human)
regulation of cellular response to stressMu-type opioid receptorHomo sapiens (human)
regulation of NMDA receptor activityMu-type opioid receptorHomo sapiens (human)
neuropeptide signaling pathwayMu-type opioid receptorHomo sapiens (human)
immune responseDelta-type opioid receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerDelta-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
adult locomotory behaviorDelta-type opioid receptorHomo sapiens (human)
negative regulation of gene expressionDelta-type opioid receptorHomo sapiens (human)
negative regulation of protein-containing complex assemblyDelta-type opioid receptorHomo sapiens (human)
positive regulation of CREB transcription factor activityDelta-type opioid receptorHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylationDelta-type opioid receptorHomo sapiens (human)
response to nicotineDelta-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
eating behaviorDelta-type opioid receptorHomo sapiens (human)
regulation of mitochondrial membrane potentialDelta-type opioid receptorHomo sapiens (human)
regulation of calcium ion transportDelta-type opioid receptorHomo sapiens (human)
cellular response to growth factor stimulusDelta-type opioid receptorHomo sapiens (human)
cellular response to hypoxiaDelta-type opioid receptorHomo sapiens (human)
cellular response to toxic substanceDelta-type opioid receptorHomo sapiens (human)
neuropeptide signaling pathwayDelta-type opioid receptorHomo sapiens (human)
immune responseKappa-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayKappa-type opioid receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayKappa-type opioid receptorHomo sapiens (human)
chemical synaptic transmissionKappa-type opioid receptorHomo sapiens (human)
sensory perceptionKappa-type opioid receptorHomo sapiens (human)
locomotory behaviorKappa-type opioid receptorHomo sapiens (human)
sensory perception of painKappa-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting opioid receptor signaling pathwayKappa-type opioid receptorHomo sapiens (human)
response to insulinKappa-type opioid receptorHomo sapiens (human)
positive regulation of dopamine secretionKappa-type opioid receptorHomo sapiens (human)
negative regulation of luteinizing hormone secretionKappa-type opioid receptorHomo sapiens (human)
response to nicotineKappa-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor signaling pathwayKappa-type opioid receptorHomo sapiens (human)
maternal behaviorKappa-type opioid receptorHomo sapiens (human)
eating behaviorKappa-type opioid receptorHomo sapiens (human)
response to estrogenKappa-type opioid receptorHomo sapiens (human)
estrous cycleKappa-type opioid receptorHomo sapiens (human)
response to ethanolKappa-type opioid receptorHomo sapiens (human)
regulation of saliva secretionKappa-type opioid receptorHomo sapiens (human)
behavioral response to cocaineKappa-type opioid receptorHomo sapiens (human)
sensory perception of temperature stimulusKappa-type opioid receptorHomo sapiens (human)
defense response to virusKappa-type opioid receptorHomo sapiens (human)
cellular response to lipopolysaccharideKappa-type opioid receptorHomo sapiens (human)
cellular response to glucose stimulusKappa-type opioid receptorHomo sapiens (human)
positive regulation of p38MAPK cascadeKappa-type opioid receptorHomo sapiens (human)
positive regulation of potassium ion transmembrane transportKappa-type opioid receptorHomo sapiens (human)
response to acrylamideKappa-type opioid receptorHomo sapiens (human)
positive regulation of eating behaviorKappa-type opioid receptorHomo sapiens (human)
conditioned place preferenceKappa-type opioid receptorHomo sapiens (human)
neuropeptide signaling pathwayKappa-type opioid receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (30)

Processvia Protein(s)Taxonomy
acetylcholine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
neurotransmitter transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
dopamine:sodium symporter activitySolute carrier family 22 member 1 Homo sapiens (human)
norepinephrine:sodium symporter activitySolute carrier family 22 member 1 Homo sapiens (human)
protein bindingSolute carrier family 22 member 1 Homo sapiens (human)
monoamine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
secondary active organic cation transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
organic anion transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
organic cation transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
prostaglandin transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
pyrimidine nucleoside transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
thiamine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
putrescine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
spermidine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
quaternary ammonium group transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
toxin transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
identical protein bindingSolute carrier family 22 member 1 Homo sapiens (human)
xenobiotic transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
(R)-carnitine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
neurotransmitter transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
protein bindingSolute carrier family 22 member 3Homo sapiens (human)
monoamine transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
organic anion transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
organic cation transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
spermidine transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
quaternary ammonium group transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
toxin transmembrane transporter activitySolute carrier family 22 member 3Homo sapiens (human)
G-protein alpha-subunit bindingMu-type opioid receptorHomo sapiens (human)
G protein-coupled receptor activityMu-type opioid receptorHomo sapiens (human)
beta-endorphin receptor activityMu-type opioid receptorHomo sapiens (human)
voltage-gated calcium channel activityMu-type opioid receptorHomo sapiens (human)
protein bindingMu-type opioid receptorHomo sapiens (human)
morphine receptor activityMu-type opioid receptorHomo sapiens (human)
G-protein beta-subunit bindingMu-type opioid receptorHomo sapiens (human)
neuropeptide bindingMu-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor activityDelta-type opioid receptorHomo sapiens (human)
protein bindingDelta-type opioid receptorHomo sapiens (human)
receptor serine/threonine kinase bindingDelta-type opioid receptorHomo sapiens (human)
G protein-coupled enkephalin receptor activityDelta-type opioid receptorHomo sapiens (human)
neuropeptide bindingDelta-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor activityKappa-type opioid receptorHomo sapiens (human)
protein bindingKappa-type opioid receptorHomo sapiens (human)
receptor serine/threonine kinase bindingKappa-type opioid receptorHomo sapiens (human)
dynorphin receptor activityKappa-type opioid receptorHomo sapiens (human)
neuropeptide bindingKappa-type opioid receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (32)

Processvia Protein(s)Taxonomy
plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
basal plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
membraneSolute carrier family 22 member 1 Homo sapiens (human)
basolateral plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
apical plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
lateral plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
presynapseSolute carrier family 22 member 1 Homo sapiens (human)
nuclear outer membraneSolute carrier family 22 member 3Homo sapiens (human)
plasma membraneSolute carrier family 22 member 3Homo sapiens (human)
endomembrane systemSolute carrier family 22 member 3Homo sapiens (human)
membraneSolute carrier family 22 member 3Homo sapiens (human)
basolateral plasma membraneSolute carrier family 22 member 3Homo sapiens (human)
apical plasma membraneSolute carrier family 22 member 3Homo sapiens (human)
mitochondrial membraneSolute carrier family 22 member 3Homo sapiens (human)
neuronal cell bodySolute carrier family 22 member 3Homo sapiens (human)
presynapseSolute carrier family 22 member 3Homo sapiens (human)
endosomeMu-type opioid receptorHomo sapiens (human)
endoplasmic reticulumMu-type opioid receptorHomo sapiens (human)
Golgi apparatusMu-type opioid receptorHomo sapiens (human)
plasma membraneMu-type opioid receptorHomo sapiens (human)
axonMu-type opioid receptorHomo sapiens (human)
dendriteMu-type opioid receptorHomo sapiens (human)
perikaryonMu-type opioid receptorHomo sapiens (human)
synapseMu-type opioid receptorHomo sapiens (human)
plasma membraneMu-type opioid receptorHomo sapiens (human)
neuron projectionMu-type opioid receptorHomo sapiens (human)
plasma membraneDelta-type opioid receptorHomo sapiens (human)
synaptic vesicle membraneDelta-type opioid receptorHomo sapiens (human)
dendrite membraneDelta-type opioid receptorHomo sapiens (human)
presynaptic membraneDelta-type opioid receptorHomo sapiens (human)
axon terminusDelta-type opioid receptorHomo sapiens (human)
spine apparatusDelta-type opioid receptorHomo sapiens (human)
postsynaptic density membraneDelta-type opioid receptorHomo sapiens (human)
neuronal dense core vesicleDelta-type opioid receptorHomo sapiens (human)
plasma membraneDelta-type opioid receptorHomo sapiens (human)
neuron projectionDelta-type opioid receptorHomo sapiens (human)
nucleoplasmKappa-type opioid receptorHomo sapiens (human)
mitochondrionKappa-type opioid receptorHomo sapiens (human)
cytosolKappa-type opioid receptorHomo sapiens (human)
plasma membraneKappa-type opioid receptorHomo sapiens (human)
membraneKappa-type opioid receptorHomo sapiens (human)
sarcoplasmic reticulumKappa-type opioid receptorHomo sapiens (human)
T-tubuleKappa-type opioid receptorHomo sapiens (human)
dendriteKappa-type opioid receptorHomo sapiens (human)
synaptic vesicle membraneKappa-type opioid receptorHomo sapiens (human)
presynaptic membraneKappa-type opioid receptorHomo sapiens (human)
perikaryonKappa-type opioid receptorHomo sapiens (human)
axon terminusKappa-type opioid receptorHomo sapiens (human)
postsynaptic membraneKappa-type opioid receptorHomo sapiens (human)
plasma membraneKappa-type opioid receptorHomo sapiens (human)
neuron projectionKappa-type opioid receptorHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (94)

Assay IDTitleYearJournalArticle
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID678717Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-benzyloxyquinoline as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1526738Substrate activity at OCT1 in primary human hepatocytes assessed as increase in compound uptake at 0.1 uM incubated for 2 mins by LC-MS/MS analysis relative to control2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID624620Specific activity of expressed human recombinant UGT2B7H2000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID417162Antagonist activity against human mu opioid receptor expressed in CHO cells assessed as inhibition of DAMGO-stimulated [35S]GTPgammaS binding2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
AID1526812Ratio of unbound Cmax in human at 4 mg, po to inhibition of human OCT1 expressed in HEK293 cells assessed as reduction in ASP+ substrate uptake by microplate reader based analysis2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID128214Narcotic agonistic activity in acetic acid mouse writhing assay after subcutaneous administration of the drug1981Journal of medicinal chemistry, Dec, Volume: 24, Issue:12
Analgesic narcotic antagonists. 8. 7 alpha-Alkyl-4,5 alpha-epoxymorphinan-6-ones.
AID1526744Substrate activity at human OCT1*3 allele mutant expressed in HEK293 cells assessed as increase in compound uptake at 0.1 uM incubated for 2 mins by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1526813Ratio of unbound maximal portal vein concentration in human at 4 mg, po to inhibition of human OCT1 expressed in HEK293 cells assessed as reduction in ASP+ substrate uptake by microplate reader based analysis2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID624621Specific activity of expressed human recombinant UGT2B7Y2000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID416815Displacement of [3H]U69,593 from human kappa opioid receptor expressed in CHO cells after 60 mins by scintillation counting2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1251035Analgesic activity in rat by tail flick test2015Journal of medicinal chemistry, Oct-08, Volume: 58, Issue:19
Synthesis and Characterization in Vitro and in Vivo of (l)-(Trimethylsilyl)alanine Containing Neurotensin Analogues.
AID128307Agonistic activity by mouse acetic acid writhing test.1982Journal of medicinal chemistry, Aug, Volume: 25, Issue:8
Novel opiates and antagonists. 4. 7-Alkanoylhydromorphones.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID416816Selectivity ratio of IC50 for human delta opioid receptor to IC50 for human mu opioid receptor2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
AID678715Inhibition of human CYP2D6 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 4-methylaminoethyl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1526734Substrate activity at human OCT1 expressed in HEK293 cells assessed as increase in compound uptake at 0.05 to 0.5 uM incubated for 2 mins in presence of 2 mM MPP+ by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID417161Agonist activity at human kappa opioid receptor expressed in CHO cells assessed as stimulation of [35S]GTPgammaS binding relative to basal level2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
AID539464Solubility of the compound in 0.1 M phosphate buffer at 600 uM at pH 7.4 after 24 hrs by LC/MS/MS analysis2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID1526743Substrate activity at human OCT1*2 allele mutant expressed in HEK293 cells assessed as increase in compound uptake at 0.1 uM incubated for 2 mins by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID678716Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using diethoxyfluorescein as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1526735Substrate activity at human OCT1 expressed in HEK293 cells assessed as increase in compound uptake at 0.1 uM incubated for 2 mins in presence of 2 mM MPP+ by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID678712Inhibition of human CYP1A2 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using ethoxyresorufin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1526742Substrate activity at human OCT3 expressed in HEK293 cells assessed as increase in compound uptake by measuring Km incubated for 2 mins by LC-MS/MS analysis based Michaelis-Menten plot analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1526748Substrate activity at human OCT1*8 allele mutant expressed in HEK293 cells assessed as increase in compound uptake at 0.1 uM incubated for 2 mins by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID624607Specific activity of expressed human recombinant UGT1A32000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID1526810Unbound Cmax in human at 4 mg, po2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1526736Substrate activity at human OCT1 expressed in HEK293 cells assessed as increase in compound uptake by measuring Vmax incubated for 2 mins by LC-MS/MS analysis based Michaelis-Menten plot analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1526739Substrate activity at OCT1 in primary human hepatocytes assessed as increase in compound uptake at 0.1 uM incubated for 2 mins in presence of 2 mM MPP+ by LC-MS/MS analysis relative to control2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID624611Specific activity of expressed human recombinant UGT1A82000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID128495Analgesic activity was measured by acetic acid writhing test in mouse by giving subcutaneous injection1980Journal of medicinal chemistry, Feb, Volume: 23, Issue:2
Analgesic narcotic antagonists. 1. 8 beta-Alkyl-, 8 beta-acyl-, and 8 beta-(tertiary alcohol)dihydrocodeinones and -dihydromorphinones.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID678722Covalent binding affinity to human liver microsomes assessed per mg of protein at 10 uM after 60 mins presence of NADPH2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID678721Metabolic stability in human liver microsomes assessed as GSH adduct formation at 100 uM after 90 mins by HPLC-MS analysis2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1526747Substrate activity at human OCT1*6 allele mutant expressed in HEK293 cells assessed as increase in compound uptake at 0.1 uM incubated for 2 mins by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1526751Inhibition of human OCT1 expressed in HEK293 cells assessed as reduction in ASP+ substrate uptake by microplate reader based analysis2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1526809Cmax in human at 4 mg, po2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID178144Analgesic agonist activity in heat stimulus rat tail-flick assay on subcutaneous administration1981Journal of medicinal chemistry, Jun, Volume: 24, Issue:6
Analgesic narcotic antagonists. 5. 7,7-Dimethyldihydrocodeinones and 7,7-dimethyldihydromorphinones.
AID128023Compound was tested for analgesia in mouse writhing assay by subcutaneous administration1980Journal of medicinal chemistry, Dec, Volume: 23, Issue:12
Analgesic narcotic antagonists. 4. 7-Methyl-N-(cycloalkylmethyl)-3-hydroxymorphinan-6-ones and -isomorphinan-6-ones.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID416814Displacement of [3H]naltrindole from human delta opioid receptor expressed in CHO cells after 3 hrs by scintillation counting2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
AID131018Analgesic agonist activity in acetic acid induced mouse writhing assay, subcutaneous administration1981Journal of medicinal chemistry, Jun, Volume: 24, Issue:6
Analgesic narcotic antagonists. 5. 7,7-Dimethyldihydrocodeinones and 7,7-dimethyldihydromorphinones.
AID1526732Substrate activity at human OCT1 expressed in HEK293 cells assessed as increase in compound uptake at 0.1 uM incubated for 2 mins by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1526752Passive membrane permeability by LC-MS/MS analysis based PAMPA2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID180157Effective dose was measured by using rat tail flick assay after subcutaneous administration1980Journal of medicinal chemistry, Feb, Volume: 23, Issue:2
Analgesic narcotic antagonists. 2. 8-Alkymorphinan-6-ones.
AID127831Narcotic agonist activity using acetic acid induced writhing in the mouse upon subcutaneous administration1983Journal of medicinal chemistry, Jul, Volume: 26, Issue:7
Analgesic narcotic antagonists. 15. Potent narcotic agonist 7 beta-(arylalkyl)-4,5 alpha-epoxymorphinans.
AID1526733Substrate activity at human OCT1 expressed in HEK293 cells assessed as increase in compound uptake at 0.5 uM incubated for 2 mins by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID678713Inhibition of human CYP2C9 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-methoxy-4-trifluoromethylcoumarin-3-acetic acid as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID177776Analgesic activity measured by rat tail flick assay following s.c. administration.1980Journal of medicinal chemistry, Feb, Volume: 23, Issue:2
Analgesic narcotic antagonists. 1. 8 beta-Alkyl-, 8 beta-acyl-, and 8 beta-(tertiary alcohol)dihydrocodeinones and -dihydromorphinones.
AID1526737Substrate activity at human OCT1 expressed in HEK293 cells assessed as increase in compound uptake by measuring Km incubated for 2 mins by LC-MS/MS analysis based Michaelis-Menten plot analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID417165Antagonist activity against human kappa opioid receptor expressed in CHO cells assessed as inhibition of U50488-stimulated [35S]GTPgammaS binding2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
AID678714Inhibition of human CYP2C19 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 3-butyryl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID417160Agonist activity at human kappa opioid receptor expressed in CHO cells assessed as stimulation of [35S]GTPgammaS binding2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
AID417157Agonist activity at human mu opioid receptor expressed in CHO cells assessed as stimulation of [35S]GTPgammaS binding relative to basal level2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
AID416813Displacement of [3H]DAMGO from human mu opioid receptor expressed in CHO cells after 60 mins by scintillation counting2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
AID311367Permeability coefficient in human skin2007Bioorganic & medicinal chemistry, Nov-15, Volume: 15, Issue:22
Transdermal penetration behaviour of drugs: CART-clustering, QSPR and selection of model compounds.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1526749Substrate activity at human OCT1*7 allele mutant expressed in HEK293 cells assessed as increase in compound uptake at 0.1 uM incubated for 2 mins by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID416817Selectivity ratio of IC50 for human kappa opioid receptor to IC50 for human mu opioid receptor2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
AID132133The effective dose was measured by using mouse writhing assay after the compound administered subcutaneously.1980Journal of medicinal chemistry, Feb, Volume: 23, Issue:2
Analgesic narcotic antagonists. 2. 8-Alkymorphinan-6-ones.
AID1526741Substrate activity at human OCT3 expressed in HEK293 cells assessed as increase in compound uptake by measuring Vmax incubated for 2 mins by LC-MS/MS analysis based Michaelis-Menten plot analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID624613Specific activity of expressed human recombinant UGT1A102000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID178325Compound was tested for antinociceptive activity in heat stimulus rat tail flick assay after subcutaneous administration of the drug1981Journal of medicinal chemistry, Dec, Volume: 24, Issue:12
Analgesic narcotic antagonists. 8. 7 alpha-Alkyl-4,5 alpha-epoxymorphinan-6-ones.
AID417156Agonist activity at human mu opioid receptor expressed in CHO cells assessed as stimulation of [35S]GTPgammaS binding2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
AID178161Antagonist activity in rat tail flick assay by subcutaneous administration1980Journal of medicinal chemistry, Dec, Volume: 23, Issue:12
Analgesic narcotic antagonists. 4. 7-Methyl-N-(cycloalkylmethyl)-3-hydroxymorphinan-6-ones and -isomorphinan-6-ones.
AID1526811Unbound maximal portal vein concentration of in human at 4 mg, po2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1526731Substrate activity at human OCT1 expressed in HEK293 cells assessed as increase in compound uptake at 0.05 uM incubated for 2 mins by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1526745Substrate activity at human OCT1*4 allele mutant expressed in HEK293 cells assessed as increase in compound uptake at 0.1 uM incubated for 2 mins by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1346329Human kappa receptor (Opioid receptors)2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
AID1346364Human mu receptor (Opioid receptors)2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
AID1346361Human delta receptor (Opioid receptors)2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Syntheses of novel high affinity ligands for opioid receptors.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,344)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990318 (23.66)18.7374
1990's173 (12.87)18.2507
2000's281 (20.91)29.6817
2010's400 (29.76)24.3611
2020's172 (12.80)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials374 (25.12%)5.53%
Reviews96 (6.45%)6.00%
Case Studies199 (13.36%)4.05%
Observational21 (1.41%)0.25%
Other799 (53.66%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (190)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Wound Infiltration With Liposomal Bupivacaine With or Without Intrathecal Analgesia in Laparotomy for Gynecological Malignancy: A Randomized Controlled Trial [NCT04258631]Phase 4104 participants (Actual)Interventional2020-07-09Completed
Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled :A Randomized, Parallel Controlled Trial [NCT05848635]Phase 488 participants (Anticipated)Interventional2023-05-01Not yet recruiting
Spinal Hydromorphone Versus Morphine for Post-Cesarean Delivery Analgesia: A Non-Inferiority Trial [NCT03592992]Phase 4126 participants (Actual)Interventional2020-11-11Completed
Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation: A Dose-exploration and Effectiveness Study [NCT04436224]Phase 4530 participants (Anticipated)Interventional2020-09-04Recruiting
A Single-Dose, Randomized, Double Blind, Placebo and Active Controlled Cross-Over Study to Evaluate the Abuse Potential of Three Doses of GRT0151Y in Adult Non-dependent Recreational Opiate Users [NCT03768024]Phase 176 participants (Actual)Interventional2007-06-21Completed
A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 in Subjects Undergoing Complete Abdominoplasty [NCT03789318]Phase 254 participants (Actual)Interventional2018-12-03Completed
Postoperative Analgesic Effect of Hydromorphone on Chinese Patients Receiving Partial Pulmonary Resection Under Video-assisted Thoracoscopy [NCT03648008]Phase 4171 participants (Actual)Interventional2018-05-05Completed
Spinal Anesthesia for Enhanced Recovery After Liver Surgery [NCT03715517]128 participants (Anticipated)Interventional2018-10-04Recruiting
Ultrasound-guided (US) Serratus Anterior Plane Block (SAPB) for Acute Rib Fractures in the Emergency Department (ED) [NCT03619785]Phase 470 participants (Anticipated)Interventional2018-11-06Recruiting
Intrathecal (IT) Hydromorphone for Cesarean Section (C/S): A Dose Finding Study [NCT02067520]Phase 454 participants (Actual)Interventional2014-01-31Completed
Analgesic Response to Opioid Analgesics in Buprenorphine-Maintained Individuals [NCT02136784]12 participants (Anticipated)Interventional2014-04-30Recruiting
Inhaled PPP001 Versus Immediate-release Oral Opioids for the Management of Breakthrough Pain in Cancer Subjects: a Randomized, Open Label, Crossover, Comparison Study [NCT03564548]Phase 220 participants (Anticipated)Interventional2021-05-26Recruiting
Effect of Methadone and Hydromorphone on the QT Interval After Anesthesia and Surgery [NCT03893734]Phase 4140 participants (Anticipated)Interventional2018-05-01Recruiting
[NCT01172782]60 participants (Actual)Interventional2009-07-31Completed
The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia [NCT00385541]Phase 450 participants (Actual)Interventional2003-11-30Completed
Eliminating Narcotic Prescriptions From Outpatient Minimally Invasive Gynecologic Surgery: a Randomized Controlled Trial [NCT04837014]88 participants (Anticipated)Interventional2022-07-04Recruiting
Randomized, Embedded, Multifactorial Adaptive Platform for Perioperative Medicine at UPMC (UPMC REMAP): Core Protocol - Enhanced Recovery Protocols (ERP) [NCT04606264]Phase 32,500 participants (Anticipated)Interventional2023-05-15Recruiting
Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone in Female Patients Before Anesthesia Induction [NCT04396587]Phase 480 participants (Actual)Interventional2020-05-20Completed
Effect of Opioid Infusion Rate on Abuse Liability Potential and Analgesic Efficacy of Intravenous Hydromorphone Among Inpatients With Cancer Pain: A Randomized Crossover Trial [NCT04296305]Phase 484 participants (Actual)Interventional2020-09-10Active, not recruiting
An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Hydromorphone Hydrochloride (8 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (DILAUDID® [NCT00853554]Phase 124 participants (Actual)Interventional2002-12-31Completed
The Effects of ECMO on the Pharmacokinetics of Hydromorphone [NCT05565495]Phase 224 participants (Anticipated)Interventional2022-01-01Recruiting
Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery: A Randomized, Double-blind, Parallel, Placebo-controlled Trial [NCT05579223]Phase 2150 participants (Anticipated)Interventional2022-10-17Recruiting
Efficacy and Safety of Opioid Rotation Compared With Opioid Dose Escalation in Patients With Moderate to Severe Cancer Pain - Open Label, Randomized, Prospective Study [NCT02084355]Phase 3136 participants (Anticipated)Interventional2014-04-30Not yet recruiting
Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study [NCT02110719]Phase 4138 participants (Actual)Interventional2014-03-31Completed
A Hydromorphone High Resolution Pharmacokinetic-Pharmacodynamic Fingerprint as the Basis for Identifying Sex Differences in Opioid Pharmacokinetics and Pharmacodynamics [NCT01123486]0 participants (Actual)Interventional2015-01-31Withdrawn(stopped due to PI relocated to new university)
Randomized Clinical Trial of IV Acetaminophen as an Adjuvant Analgesic to IV Hydromorphone for Treatment of Acute Severe Pain in Non-Elderly Emergency Department Patients [NCT03553498]Phase 3162 participants (Actual)Interventional2018-11-27Completed
Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery [NCT02295124]Phase 4200 participants (Actual)Interventional2012-08-31Completed
Preventing Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block: A Randomized Controlled Trial of Pre-emptive Opioid Treatment Compared to Placebo [NCT02939209]Phase 473 participants (Actual)Interventional2017-04-20Completed
The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion: a Prospective, Randomized Controlled Trial [NCT03104816]Phase 428 participants (Actual)Interventional2016-10-31Terminated(stopped due to Could not get an approval from Department Reviewer for the study continuation.)
Intraoperative Opioids and Postoperative Recovery After Hepatobiliary or Foregut Surgery [NCT01546948]Phase 460 participants (Anticipated)Interventional2011-08-31Completed
A Single-dose, Nested-randomized, Double-blind, Double-dummy, Placebo- and Active-controlled Crossover Trial to Evaluate the Abuse Potential of 3 Doses of GRT6005 in Adult Non-dependent Recreational Opioid Users [NCT03757559]Phase 1226 participants (Actual)Interventional2013-04-15Completed
Evaluation of Fentalogs and Their Metabolites in Hair of Patients in a Monitored Clinical Context by Means of Hair Analysis [NCT05740657]225 participants (Anticipated)Observational [Patient Registry]2022-12-06Recruiting
Safety and Speed of Onsent of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg in the Treatment of Adult ED Patients With Moderate to Severe Pain [NCT00682435]Phase 4230 participants (Actual)Interventional2007-08-31Completed
Optimization of Post-Operative Pain Following Orthognathic Surgery With Personalized Opioid Prescription and Tapering Protocols [NCT05708521]Phase 4200 participants (Anticipated)Interventional2023-04-24Recruiting
Acetaminophen 1g IV vs Hydromorphone 1mg IV for the Treatment of Acute Pain in the Emergency Department [NCT03107481]Phase 4220 participants (Actual)Interventional2017-06-04Completed
Pain Management After Elective Shoulder Surgery: A Randomized Quantitative Study Comparing Hydromorphone With Piritramide [NCT03541759]Phase 448 participants (Actual)Interventional2018-01-02Completed
A Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists in Physically Dependent Opioid Users With Moderate-to-Severe Opioid Use Disorder [NCT03389750]Phase 216 participants (Actual)Interventional2018-03-15Completed
"ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial" [NCT03987022]Phase 466 participants (Actual)Interventional2019-08-01Completed
A Confirmatory, Placebo-controlled, Randomised, Double-blind, Single-dummy, Parallel Group, Ratio-finding Study in Constipated Pain Patients to Establish an Optimal Hydromorphone - Naloxone Ratio With an Improved Bowel Function and a Comparable Analgesic [NCT00992576]Phase 2/Phase 3600 participants (Anticipated)Interventional2010-01-31Completed
Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain: An Open Label Study [NCT01207596]Phase 430 participants (Actual)Interventional2010-09-30Completed
A Randomized Controlled Trial to Compare Pain Medications in Children Undergoing Strabismus Surgery [NCT02789969]128 participants (Anticipated)Interventional2016-04-30Recruiting
Evaluation of Ultrasound-Assisted Thoracic Epidural Placement in Patients Undergoing Upper Abdominal and Thoracic Surgery: A Randomized, Double-Blind Study [NCT02785055]70 participants (Actual)Interventional2009-04-30Completed
Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease: Understanding Patients' and Caregivers' Experiences of Opioid Therapy [NCT00982891]Phase 2/Phase 345 participants (Actual)Interventional2010-03-31Completed
Remifentanil Intravenous Patient-controlled Labor Analgesia for Nulliparous Women [NCT00710086]Phase 41,000 participants (Actual)Interventional2008-07-31Completed
Efficacy of an Acute Pain Titration Protocol Driven by Patient Response to a Simple Query: Do You Want More Pain Medication? [NCT01892709]Phase 4215 participants (Actual)Interventional2013-06-30Completed
Safety and Speed of Onset of a Fixed Dose of Intravenous Hydromorphone in the Treatment of Adult Patients Presenting to the Emergency Department With Acute Severe Pain [NCT00305110]Phase 2298 participants (Actual)Interventional2006-01-31Completed
Medications Development for Drug Abuse Disorders [NCT00499746]Phase 1/Phase 220 participants (Actual)Interventional2007-11-30Completed
Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion [NCT00644111]32 participants (Actual)Interventional2008-02-29Completed
the Effect of Different Drugs and Infusion Ways on Degree of Comfort for Patients Undergoing Spinal Neoplasm Surgery [NCT04111328]Phase 4600 participants (Actual)Interventional2019-10-08Completed
Determination of the ED50 of Intrathecal Hydromorphone for Post-cesarean Section Pain Relief [NCT01598545]Phase 220 participants (Actual)Interventional2013-02-28Completed
Generation of Biological Samples Positive to Hydromorphone for Anti-doping Control [NCT04081376]Phase 12 participants (Actual)Interventional2019-11-20Completed
Hydromorphone PCA Intravenously vs Sustained-Release Morphine Orally in Cancer Patients With Severe Pain After Successful Titration: A Multicenter, Randomized, Controlled, Phase II Trial [NCT04243954]Phase 295 participants (Actual)Interventional2020-04-10Completed
A Randomized, Double-Blind, Active Controlled, Multi-center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCl Once-daily Compared With Oxycodone HCL Controlled-release Twice Daily in Subjects With Cancer Pain [NCT01205126]Phase 3260 participants (Actual)Interventional2009-12-31Completed
Does the Use of Intravenous Patient Controlled Analgesia (IVPCA) Increase Opioid Consumption and Side Effects in Fast Track Orthopedic Procedures? [NCT02880800]80 participants (Anticipated)Interventional2016-08-31Recruiting
Hydromorphone OROS in Korean Cancer Patients: Evaluation of Its Clinical Usefulness in Improvement of Sleep Disturbance [NCT00766831]Phase 4190 participants (Actual)Interventional2008-10-31Completed
Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries [NCT01866254]Early Phase 145 participants (Actual)Interventional2013-05-31Completed
Acute Pain Management in Patients on Opioid Replacement Therapy [NCT03933865]Phase 11 participants (Actual)Interventional2018-10-31Terminated(stopped due to The COVID-19 pandemic and recruitment difficulties prompted the investigators to terminate study early.)
The Safety of Fentanyl TAIFUN Treatment After Titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients [NCT00822614]Phase 3500 participants (Anticipated)Interventional2008-12-31Recruiting
Randomized, Open-Label, Comparative Parallel Group Study to Assess Efficacy and Safety on Flexible Dosages of OROS Hydromorphone Once-Daily Compared to Sustained Release Oxycodone Twice Daily in Subjects With Chronic Non-malignant Pain Requiring Continuou [NCT00261495]Phase 3504 participants (Actual)Interventional2006-03-31Completed
A Randomized Clinical Trial Comparing Intravenous Morphine and Intravenous Hydromorphone in the Treatment of Adult ED Patients With Moderate to Severe Pain [NCT00305058]Phase 2/Phase 3194 participants (Actual)Interventional2005-07-31Completed
A Multi-center, Open-label, Dose Titration Study Pharmacokinetics/Pharmacodynamics, Safety, and Efficacy of Hydromorphone Oral Solution in Subjects From 28 Days to 16 Years of Age, Who Require Opioid Analgesics for Postoperative Pain [NCT00465647]Phase 4116 participants (Actual)Interventional2007-04-30Completed
Abciximab (ReoPro) as a Therapeutic Intervention for Sickle Cell Vaso-Occlusive Pain Crisis [NCT01932554]Phase 20 participants (Actual)Interventional2013-11-30Withdrawn(stopped due to Insufficient recruitment)
Breakthrough Cancer Pain: A Randomized Trial Comparing Oral Morphine Immediate Release and Self-Administration of Subcutaneous Hydromorphone Using an Injection Pen [NCT00125801]Phase 350 participants (Anticipated)Interventional2005-08-31Terminated(stopped due to Lack of patients)
A Phase 3, Randomized, Double-Blind, Fixed-Dose, Parallel Group Comparison of Controlled-Release Hydromorphone HCI vs Placebo in Subjects With Osteoarthritis [NCT00411164]Phase 3990 participants (Actual)Interventional2003-11-30Completed
Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain [NCT01946555]150 participants (Actual)Observational2013-09-30Completed
Biobehavioral Studies of Opioid Drug Seeking Behavior: Study 1 [NCT00218309]16 participants Observational2003-09-30Completed
Effects of Esketamine on Postoperative Pain, Anxiety and Depression in Patients Undergoing Tumor Surgery [NCT04613869]282 participants (Anticipated)Interventional2020-08-15Active, not recruiting
A Comparison of Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease [NCT03933397]Phase 3328 participants (Actual)Interventional2019-08-13Terminated(stopped due to Due to COVID enrollment numbers needed to meet the primary endpoint will not be met.)
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy [NCT04429022]Phase 368 participants (Actual)Interventional2020-11-24Completed
Phase 4 Study of Postoperative Pain Therapy With Hydromorphone Using Patient-Controlled Target-Controlled Infusion (TCI-PCA) vs. Patient-Controlled Analgesia (PCA) After Elective Cardiac Surgery [NCT02035709]Phase 450 participants (Actual)Interventional2013-12-31Completed
Effects of Intravenous Local Anesthetic on Bowel Function After Colectomy [NCT00600158]Phase 345 participants (Actual)Interventional2005-04-30Completed
Examining the Relationship Amongst Opioid Subjective Effects and Pharmacokinetics of Extended Release Opioids at Shortened Dosing Intervals in Patients With Chronic Pain: a Randomized, Blinded, N-of-1 Case Series Feasibility Study [NCT04132011]Phase 40 participants (Actual)Interventional2019-05-01Withdrawn(stopped due to No recruitment (Feasibility study).)
Dose and Response of Intrathecal Hydromorphone in Patients Undergoing Cesarean Section at Virginia Commonwealth University Health System [NCT02787928]Phase 114 participants (Actual)Interventional2016-04-30Terminated(stopped due to Lack of reliable supply of of preservative free IV Hydromorphone for intrathecal use.)
Cancer Pain Management With Hydromorphone HCl ORal Osmotic System in Korean Cancer Patient: Evaluation of Its Clinical Usefulness in Reduction of Breakthrough Pain Medication Frequency [NCT01006356]Phase 4141 participants (Actual)Interventional2008-10-31Completed
An Exploratory, Single-Dose, Double-Blind, Randomized, Placebo-Controlled Crossover Study to Evaluate The Subjective and Objective Effects of Extended-Release Oxymorphone Compared to Controlled-Release Oxycodone in Healthy Non-Dependent Recreational Opioi [NCT00955110]Phase 478 participants (Actual)Interventional2009-06-30Completed
Safety and Tolerability of Long-term Administration of Dilaudid CR (Hydromorphone HCI) [NCT00410748]Phase 3388 participants (Actual)InterventionalCompleted
Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder: A Randomized Controlled Trial [NCT04234191]Phase 250 participants (Anticipated)Interventional2021-08-18Recruiting
Safety and Tolerability of Long-Term Administration of Dilaudid SR (Hydromorphone HCI) in Cancer Pain [NCT00410787]Phase 368 participants (Actual)InterventionalCompleted
A Randomized, Double-Blind, Repeated Dose, Parallel-Group Comparison of the Efficacy & Tolerability of Dilaudid SR Tablets and Immediate Release Dilaudid Tablets (Hydromorphone HCI) in Patients With Chronic Pain [NCT00410943]Phase 3169 participants (Actual)InterventionalCompleted
Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery: A Randomized Trial Comparing Patient-Controlled Intravenous Analgesia (PCA) to Scheduled Intravenous Analgesia [NCT01442818]54 participants (Actual)Interventional2010-09-30Completed
Comparison of Short-term Sustained-release Opioid With Immediate-release Opioid for Acute Pain Management Following Open Abdominal Urologic Surgeries [NCT05375916]80 participants (Anticipated)Interventional2022-05-03Recruiting
Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy [NCT04300231]Phase 3160 participants (Anticipated)Interventional2019-10-22Active, not recruiting
A Single-Dose, Open-Label, Randomized, Crossover Dose Proportionality Study to Evaluate the Effect of Dose on the Pharmacokinetics of 8, 16, 32 and 64 mg OROS Hydromorphone Under Fasted Conditions in Healthy Adult Taiwanese Subjects [NCT01487512]Phase 129 participants (Actual)Interventional2011-03-31Completed
A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetic Profile of OROS Hydromorphone in Healthy Adult Taiwanese Subjects Having Different Genotypes for the UGT2B7 Gene [NCT01487564]Phase 129 participants (Actual)Interventional2011-10-31Completed
True Functional Restoration and Analgesia in Non-Radicular Low Back Pain: a Prospective Double Blind, Placebo-controlled Study of Hydromorphone ER [NCT01455519]Phase 451 participants (Actual)Interventional2011-10-31Completed
Pharmacokinetic-pharmacodynamic Modeling of the Postoperative Pain Sensation During Patient-controlled Analgesia With Target-controlled Infusion of Hydromorphone, Taking Into Account the Interaction With Intraoperatively Administered Sufentanil for Electi [NCT01490268]Phase 450 participants (Actual)Interventional2011-11-30Completed
Ketamine and Hydromorphone PCA Analgesia for Antineoplastic-Induced Pediatric Mucositis [NCT00474110]Phase 30 participants (Actual)Interventional2009-08-31Withdrawn(stopped due to Clinical practice had changed between time of initial protocol development and subject recruitment. We were not able to find eligible patients.)
A Study of the Efficacy and Safety of 8 Mg Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain [NCT00365898]Phase 3380 participants Interventional2005-07-31Terminated
Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery as Part of an Enhanced Recovery After Surgery Protocol: A Randomized Prospective Single- Center Trial. [NCT02958566]Phase 480 participants (Anticipated)Interventional2017-01-31Recruiting
An Open Label Evaluation of the Dose Proportionality of Dilaudid SR (OROS� Hydromorphone HCL) Tablets 8mg, 16mg, 32mg, and 64mg [NCT00398957]Phase 132 participants (Actual)InterventionalCompleted
A Phase 3, Open-Label, Single-Arm Study To Assess The Safety Of Hydromorphone Hydrochloride Delivered By Intrathecal Administration [NCT01709747]Phase 3364 participants (Actual)Interventional2013-06-30Completed
Outcomes of Perioperative Epidural Analgesia in Gynecologic Oncology Patients: A Parallel Prospective Cohort and Randomized Clinical Study [NCT00295945]240 participants (Actual)Observational2005-03-31Completed
Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement) [NCT03726268]Phase 41,000 participants (Anticipated)Interventional2018-11-29Active, not recruiting
A Phase III, Variable-Dose Titration Followed by a Randomized Double-Blind Study of Controlled-Release OROS® Hydromorphone HCl (NMED-1077) Compared to Placebo in Patients With Chronic Low Back Pain [NCT00549042]Phase 3459 participants (Actual)Interventional2007-10-31Completed
A Randomized, Single-Dose Opiate Challenge Study of Medisorb® Naltrexone in Opioid-Using Adults [NCT01218984]Phase 227 participants (Actual)Interventional2002-03-31Completed
Topical Hydromorphone for Wound Healing [NCT00177060]Phase 1/Phase 250 participants (Anticipated)Interventional2003-10-31Terminated(stopped due to No funding available.)
Biobehavioral Study of Opioid Drug Seeking Behavior: Study 2 [NCT00218361]16 participants (Anticipated)Observational2005-08-31Completed
"Prime Rib Time: Randomized Control Trial Evaluating the Use of Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures" [NCT02604589]10 participants (Actual)Interventional2016-03-31Terminated(stopped due to resource reallocation)
Clinical Usefulness and Quality of Life of OROS Hydromorphone in Strong Opioid-Naïve Cancer Pain Patients; Multicenter, Prospective, Open-Label and Observational Study [NCT01532895]400 participants (Actual)Observational2011-09-30Completed
Analgesic and Hemodynamic Effects of Continuous Epidural Analgesia Compared to Paravertebral Block in Liver Resection Patients [NCT02909322]Phase 450 participants (Anticipated)Interventional2016-04-30Recruiting
Randomized Clinical Trial Comparing Intravenous Hydromorphone to Usual Care [NCT01429298]Phase 4350 participants (Actual)Interventional2010-03-31Completed
An Open-Label, Repeated-Dose Trial to Characterize the Efficacy and Safety, and Impact on Quality of Life Measures of Dilaudid CR (Hydromorphone HCI) in Patients With Chronic Low Back Pain [NCT00398788]Phase 2207 participants (Actual)InterventionalCompleted
An Open-Label Evaluation of the Independent Effect of Coadministration of a High Fat Meal and Naltrexone Blockade on the Pharmacokinetic Profile of Dilaudid OROS (Hydromorphone HCL) 16 mg [NCT00399295]Phase 130 participants (Actual)InterventionalCompleted
Randomized Prospective Study Comparing Paravertebral Catheters, Single Shot Paravertebral Block, Thoracic Epidural, for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery [NCT03151434]Phase 3147 participants (Actual)Interventional2017-02-07Completed
UW14030: Epidural Anesthesia as Part of an Enhanced Recovery Pathway in Gynecologic Surgery [NCT02423876]Phase 3104 participants (Actual)Interventional2015-03-17Completed
Patient-controlled Intravenous Analgesia Combined With Different Opioid Receptors for Gastrointestinal Surgery [NCT05576675]Phase 34,342 participants (Actual)Interventional2018-05-01Completed
A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR (Hydromorphone HCI) in Patients With Chronic Non-Malignant Pain [NCT00410644]Phase 3463 participants (Actual)InterventionalCompleted
A Repeated-Dose Pharmacokinetic Evaluation of Dilaudid SR Tablets (Hydromorphone HCI) in Patients With Chronic Pain [NCT00410878]Phase 122 participants (Actual)InterventionalCompleted
A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR( Hydromorphone HCI) in Patients With Chronic Cancer Pain [NCT00411034]Phase 3463 participants (Actual)InterventionalCompleted
Safety, Efficacy and Impact on Quality of Life of Long-Term Administration of Dilaudid CR (Hydromorphone HCI) in Patients With Chronic Low Back Pain [NCT00411268]Phase 3207 participants (Actual)InterventionalCompleted
A Randomized, Open-Label, Single-Dose, Pilot Study to Evaluate the Safety and Efficacy of OROS Hydromorphone in Patients With Acute, Moderate-to-Severe Postoperative Pain [NCT00411307]Phase 250 participants (Actual)InterventionalCompleted
A Randomized, Repeated- Dose, Parallel-Group Comparison of Safety, Efficacy, and Quality of Life Measures With Dilaudid CR (Hydromorphone HCI) or Oxycontin (Oxycodone HCI) in Patients With Chronic Osteoarthritis [NCT00399048]Phase 3140 participants (Actual)InterventionalCompleted
Effects of Buprenorphine/Naloxone in Non-Dependent Opioid Abusers [NCT00158236]7 participants Interventional1997-01-31Completed
Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute, Severe Pain: A Randomized Clinical Trial [NCT00195910]Phase 2198 participants (Actual)Interventional2004-10-31Completed
Methadone and Hydromorphone For Spinal Surgery [NCT02107339]Phase 4120 participants (Actual)Interventional2014-03-31Completed
A Randomized Controlled Trial Comparing Protocolized Versus Non-protocolized Treatment of Adult ED Patients With Acute Severe Pain [NCT00627367]Phase 3224 participants (Actual)Interventional2007-12-31Completed
Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study [NCT01943565]Phase 429 participants (Actual)Interventional2014-12-31Terminated(stopped due to Research question answered by another group of researchers (Sviggum et al))
A Phase III, Flexible Dose Titration Followed by a Randomized Double-Blind Study of Controlled Release OROS Hydromorphone HCL Compared to Placebo in Patients With OA Pain [NCT00631319]Phase 3343 participants (Actual)Interventional2008-02-29Completed
Influence of Body Size and Composition on Response to Hydromorphone in ED Patients With Acute Pain [NCT01675778]Phase 2174 participants (Actual)Interventional2011-10-31Completed
A Randomized, Double-Blind, Controlled Trial of Hydromorphone (Immediate and Sustained- Release) vs Morphine (Immediate and Sustained-release) in Cancer Pain [NCT00410540]Phase 3202 participants (Actual)InterventionalCompleted
Analgesic Effects and Abuse Liability of Intravenous Hydromorphone and Buprenorphine in Pain-free Opioid Dependent Participants [NCT01642030]Phase 1132 participants (Actual)Interventional2013-08-31Completed
SALOME: Multi-Centre, Double Blind Randomized Controlled Trial Comparing The Effectiveness Of Diacetylmorphine Vs. Hydromorphone For The Treatment Of Long-Term Injection Opioid Users Who Do Not Benefit From Available Therapies [NCT01447212]Phase 3202 participants (Actual)Interventional2011-12-31Completed
A Prospective, Open-Label, Multicenter, Single-Arm, Interventional Study to Evaluate the Efficacy and Tolerability of Once-Daily Oros Hydromorphone for Cancer Pain Treatment in Korean Cancer Patients. [NCT01621100]Phase 4106 participants (Actual)Interventional2011-12-31Completed
A Comparison of Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery: A Prospective Randomized Study [NCT03115151]Phase 446 participants (Actual)Interventional2017-05-08Terminated(stopped due to The surgical team has difficulty to find level 1 and 2 fusions for the study.)
Randomized, Double Blind, Cross Over Study Comparing Effectiveness of Traditional Opioids Versus Opioids in Admixture With Bupivacaine Upon Self-administration of Boluses Via a Personal Therapy Manager (PTM) in Intrathecal Pumps [NCT02886286]Phase 417 participants (Actual)Interventional2016-05-31Completed
A Comparison Trial Between Patient Controlled Intravenous Analgesia (PCA) and Epidural Analgesia for Pectus Excavatum Repair [NCT02056301]Phase 462 participants (Actual)Interventional2012-08-31Terminated(stopped due to New method of pain control pushed by surgeons.)
A Blinded, Randomized Controlled Trial of Opioid Analgesics for the Management of Acute Fracture Pain in Adults Discharged From the Emergency Department [NCT03478423]5 participants (Actual)Interventional2018-02-05Terminated(stopped due to Study failed to recruit in sufficient numbers and was determined to not be feasible.)
An Open-Label Study to Evaluate the Single Dose Pharmacokinetic Profile and Safety of OROS® Hydromorphone in Chinese Subjects With Cancer Who Are Not Opioid Tolerant [NCT01824524]Phase 112 participants (Actual)Interventional2011-12-31Completed
Randomized Clinical Trial of IV Acetaminophen as an Analgesic Adjunct to IV Hydromorphone in the Treatment of Acute Severe Pain in Elderly ED Patients [NCT02621619]Phase 4159 participants (Actual)Interventional2016-03-31Completed
Randomized Controlled Trial Evaluating the Transcutaneous Carbon Dioxide Measurements in Obese Women Using Intrathecal Morphine Versus Patient-Controlled Intravenous Hydromorphone for Post-Cesarean Analgesia [NCT03282669]Phase 40 participants (Actual)Interventional2019-08-31Withdrawn(stopped due to Change in institutional policy. Change in resources available.)
"Does a 1 Plus 1 Hydromorphone Pain Protocol Have a Similar Rate of Respiratory Depression to Physician Discretion Protocol in a Geriatric Population With Moderate to Severe Pain?" [NCT01784991]116 participants (Actual)Interventional2011-12-31Terminated(stopped due to difficulty in recruiting)
A Study of Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries: The No OUCH Trials [NCT03767933]Phase 2710 participants (Actual)Interventional2019-04-20Completed
Intrathecal Opioids for Pain Control After Colorectal Resection: Determining the Optimal Dose [NCT04752033]Phase 480 participants (Actual)Interventional2021-03-10Completed
A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery [NCT04230681]Early Phase 1189 participants (Actual)Interventional2020-02-26Completed
Randomized, Unblinded, Phase III Trial of Thoracic Epidural Analgesia Versus Four-Quadrant Transversus Abdominus Plane Block in Oncologic Open-Incision Liver Surgery [NCT03214510]Phase 396 participants (Anticipated)Interventional2017-10-04Recruiting
Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Investigate the Analgesic Effect of OROS Hydromorphone Hydrochloride in Comparison With Placebo in Subjects With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee [NCT00980798]Phase 3288 participants (Actual)Interventional2007-10-31Completed
Post-tonsillectomy Pain Control in Adults: a Randomized Prospective Study [NCT02358850]Phase 427 participants (Actual)Interventional2016-01-31Terminated(stopped due to low enrollment)
Randomized Clinical Trial Comparing Two Protocols Using IV Hydromorphone [NCT01311895]Phase 3350 participants (Actual)Interventional2011-01-31Completed
Intravenous (IV) Patient Controlled Analgesia (PCA) With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Hydromorphone Titration: a Multi-center, Phase Ⅲ ,Randomized Trial [NCT04785768]Phase 31,600 participants (Anticipated)Interventional2021-05-01Not yet recruiting
ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Same Day Vaginal Pelvic Reconstructive Surgery: a Randomized Controlled Trial [NCT03052816]Phase 466 participants (Actual)Interventional2017-04-01Completed
Intrathecal Morphine Versus Intrathecal Hydromorphone for Analgesia Following Cesarean Delivery [NCT02789410]134 participants (Actual)Interventional2016-05-31Completed
Identification of the Optimal Analgesic Dose of Intrathecal Hydromorphone for Pediatric Patients Undergoing Posterior Spine Surgery for Idiopathic Scoliosis [NCT05552443]Phase 440 participants (Anticipated)Interventional2023-03-23Recruiting
Levorphanol as a Second Line Opioid in Cancer Patients Undergoing Opioid Rotation: An Open Label Study [NCT03579446]Early Phase 143 participants (Actual)Interventional2018-11-29Completed
Most Effective Opioid Analgesia in Ambulatory Surgeries: a Randomized Control, Investigator Blinded, Parallel Group With Superiority Design Study of Morphine Versus Hydromorphone [NCT02223377]402 participants (Actual)Interventional2015-01-31Completed
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study [NCT02389829]Phase 4127 participants (Actual)Interventional2015-03-31Completed
An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain [NCT03521102]Phase 2162 participants (Actual)Interventional2018-08-20Completed
A Prospective, Randomized, Single-Blind Study to Evaluate the Efficacy of Transversus Abdominis Plane Versus Paravertebral Regional Blockade in Patients Undergoing Laparoscopic Colectomy [NCT02164929]17 participants (Actual)Interventional2013-12-31Terminated(stopped due to Poor recruitment)
Spinal Effects of Epidural Hydromorphone [NCT00003115]Phase 340 participants (Anticipated)Interventional1996-06-30Completed
Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery - Pilot Study [NCT03128346]100 participants (Anticipated)Interventional2017-10-01Not yet recruiting
Pediatric Pain Optimization After Tonsillectomy: A Randomized Double Blind Methadone Pilot Study [NCT05244226]Phase 266 participants (Actual)Interventional2022-04-08Completed
Initial Pain Management in Pediatric Pancreatitis: Opioid vs. Non-Opioid [NCT04291599]Phase 250 participants (Anticipated)Interventional2022-03-15Recruiting
Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study. [NCT02437669]Phase 235 participants (Actual)Interventional2015-05-31Completed
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis [NCT02625181]27,034 participants (Actual)Interventional2016-07-31Completed
Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain. A Randomized Trial [NCT03300674]Phase 4154 participants (Actual)Interventional2018-01-10Completed
Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee Arthroplasty (TKA). Prospective, Randomized, Open-label Trial to Determine if Switching From Oral to Intravenous Acetaminophen and Orphenadrine for 48 Hours After TKA Improves Outcomes. [NCT02449369]Phase 4180 participants (Actual)Interventional2015-04-30Completed
A Phase III Study of Pre-operative Transversus Abdominis Plane Blocks Using the Nimbus Ambulatory Infusion System in Patients Undergoing Abdominal Free Flap-based Breast Reconstruction [NCT02601027]Phase 3120 participants (Actual)Interventional2015-11-30Completed
Determination of the ED50 of Intrathecal Hydromorphone in Laboring Women Using the Up-and-down Sequential Allocation Method [NCT01598506]Phase 222 participants (Actual)Interventional2013-09-30Completed
Analgesic Effects and Abuse Liability of Intravenous Hydromorphone and Buprenorphine in Opioid Dependent Participants With Chronic Musculoskeletal Pain [NCT02372591]Phase 114 participants (Actual)Interventional2015-08-31Completed
Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose [NCT02009722]Phase 484 participants (Actual)Interventional2014-01-31Completed
NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial [NCT05842044]Phase 2110 participants (Anticipated)Interventional2023-09-15Recruiting
Safety and Efficacy of Intravenous Hydromorphone Using Incremental Doses of 0.5 mg in Elderly ED Patients With Acute Severe Pain [NCT01429285]Phase 4350 participants (Actual)Interventional2009-07-31Completed
An Open-label, Multi-center, Non-interventional Study to Investigate Clinical Usefulness of Hydromorphone OROS in Korean Cancer Patients [NCT01273454]648 participants (Actual)Observational2009-06-30Completed
The Effects of Hydromorphone on Responses to Verbal Tasks [NCT02205983]50 participants (Actual)Interventional2015-01-31Completed
A Randomized Trial to Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain in Cancer Patients in the Emergency Department Setting [NCT02459964]Phase 484 participants (Actual)Interventional2015-09-14Completed
A Controlled, Two-Arm, Parallel Group, Randomized Withdrawal Study to Assess the Safety and Efficacy of Hydromorphone Hydrochloride Delivered by Intrathecal Administration Using a Programmable Implantable Pump [NCT01709721]Phase 3153 participants (Actual)Interventional2013-02-28Completed
Comparative Effectiveness of Multi-modal Pain Management Versus Standard Intra- and Post-operative Analgesia: Randomized Controlled Clinical Trial to Reduce Post-operative Pain and Opioid Use Among Patients Undergoing Lumbar Spine Surgery [NCT03088306]Early Phase 149 participants (Actual)Interventional2017-07-01Completed
High Dose Intravenous Lidocaine vs Hydromorphone for Acute Abdominal Pain in the Emergency Department: A Randomized, Comparative Efficacy Trial [NCT04398316]Phase 4187 participants (Anticipated)Interventional2021-02-18Recruiting
Protocolized vs Discretionary Use of Opioids in Acute Pain [NCT00825370]Phase 3350 participants (Actual)Interventional2008-10-31Completed
Hydromorphone PCA or Hydromorphone PCA With Ketamine for Acute Postoperative Pain Relief in Opioid-Dependent Chronic Pain Patients [NCT01591382]Phase 464 participants (Actual)Interventional2008-09-30Completed
Glutamatergic Mechanisms in Opioid and Cocaine Co-Use [NCT05610072]Early Phase 124 participants (Anticipated)Interventional2022-12-15Recruiting
Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia [NCT05901441]Phase 2240 participants (Actual)Interventional2022-06-01Completed
Intrathecal Hydromorphone for Labor Analgesia [NCT02277782]21 participants (Actual)Interventional2015-09-01Terminated(stopped due to Study drug shortage, COVID related suspension of recruitment)
Comparison of Intrathecal Hydromorphone and Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery [NCT02096003]Phase 280 participants (Actual)Interventional2014-05-31Completed
Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia: a Randomized Controlled Trial [NCT06036797]Phase 2240 participants (Anticipated)Interventional2023-09-17Recruiting
A Randomized Double-blinded Study to Evaluate Preincisional Dextromethorphan in Patients Undergoing Total Knee Arthroplasty and Its Effect on Postoperative Opioid Use [NCT02987920]Phase 423 participants (Actual)Interventional2017-01-31Terminated(stopped due to The surgeon changed pain control protocol for all patients. Continued enrollment impossible under approved protocol.)
A Comparison of Epidural Analgesia With Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study [NCT01986946]Phase 317 participants (Actual)Interventional2013-10-31Terminated(stopped due to Lack of recruitment.)
Synergistic Effect of Ibuprofen and Hydromorphone for Postoperative Pain [NCT02461056]90 participants (Actual)Interventional2014-06-30Completed
Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery: A Prospective Randomized Trial [NCT02356198]209 participants (Actual)Interventional2015-03-31Completed
Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent [NCT03427736]460 participants (Anticipated)Observational2018-12-13Recruiting
Multimodal Analgesia Effect on Post Surgical Patient [NCT04240626]Phase 460 participants (Anticipated)Interventional2021-01-20Recruiting
Efficacy and Outcomes of Intrathecal Analgesia As Part of an Enhanced Recovery Pathway in Colon and Rectal Surgical Patients [NCT03411109]601 participants (Actual)Observational2012-10-01Completed
Patient Controlled Analgesia (PCA) vs Non-PCA Intravenous Hydromorphone Titration for Severe Cancer Pain: A Prospective, Randomized, Controlled, Multi-center, Phase III Trial [NCT03375515]Phase 3214 participants (Actual)Interventional2018-09-29Completed
Ketamine Patient-Controlled Analgesia for Acute Pain in Native Airway Multiple and Orthopedic Trauma Patients: A Randomized, Active Comparator, Blinded Trial [NCT02062879]Phase 320 participants (Actual)Interventional2014-04-30Terminated(stopped due to Withdrawals from study due to anticipated effects from study drugs)
A Multiple-Dose Study of Blockade of Subjective Opioid Effects, Plasma Levels, and Safety of Subcutaneous Injections of Depot Buprenorphine (RBP-6000) in Subjects With Opioid Use Disorder [NCT02044094]Phase 239 participants (Actual)Interventional2013-11-30Completed
A Randomized Controlled Double-Blind Trial of Fentanyl Nasal Spray (Lazanda) Plus Hydromorphone Demand PCA Versus Placebo Nasal Spray Plus Hydromorphone Demand PCA for Treatment of Breakthrough Cancer Pain in the Emergency Department [NCT01812759]Phase 43 participants (Actual)Interventional2014-01-10Terminated
Phase 4 Study of Postoperative Pain Therapy With Hydromorphone Using Patient-Controlled Target-Controlled Infusion (TCI-PCA) vs. Patient-Controlled Analgesia (PCA) With Morphine After Elective Cardiac Surgery [NCT02483221]Phase 450 participants (Actual)Interventional2015-04-30Completed
Effect of Tramadol in Prevention of Postpartum Depression [NCT03309163]Phase 41,230 participants (Actual)Interventional2017-10-09Completed
An Open-Label, Safety and Pharmacokinetic Study of Hydromorphone Hydrochloride Extended-Release Tablets (Once-Daily Hydromorphone) in Opioid-Tolerant Pediatric Subjects With Chronic Pain [NCT02321319]Phase 35 participants (Actual)Interventional2017-03-11Terminated(stopped due to Business decision - product discontinued)
Study on the Effectiveness and Safety of OROS Hydromorphone in Pain Management Among Patients With Cancer Pain [NCT01648699]Phase 420 participants (Actual)Interventional2010-04-30Terminated(stopped due to the study was stopped due to non-availability of 4mg)
Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease [NCT02222246]Phase 4106 participants (Actual)Interventional2015-03-15Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Vitality at Week 4"
NCT00261495 (79) [back to overview]Change in Dose of Study Treatment
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With General Activity (BPI Item 9a) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Bodily Pain at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL General Health Perceptions at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL General Health Perceptions at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Health Transition at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Health Transition at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Mental Health at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Mental Health at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Physical Functioning at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Physical Functioning at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Role Emotional at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Role Emotional at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Role Physical at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Role Physical at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Social Functioning at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Social Functioning at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Vitality at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Quality of Life (QoL) Bodily Pain at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in Subject Diary Evening Mean Pain Score Pain Right Now at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Subject Diary Morning Mean Pain Score Pain Right Now at Week 24"
NCT00261495 (79) [back to overview]Amount of add-on Pain Medication
NCT00261495 (79) [back to overview]Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4
NCT00261495 (79) [back to overview]Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality (MOS Index I) at Week 4
NCT00261495 (79) [back to overview]"Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 Pain Right Now Score at Week 24 (Per Protocol [PP] Population)"
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality (MOS Index II) at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality (MOS Index II) at Week 4
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality, Sleep Quantity at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality, Snoring at Week 24
NCT00261495 (79) [back to overview]Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)
NCT00261495 (79) [back to overview]Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)
NCT00261495 (79) [back to overview]Equi-analgesic Dose at Steady State (ITT Population)
NCT00261495 (79) [back to overview]Equi-analgesic Dose at Steady-state (PP Population)
NCT00261495 (79) [back to overview]Number of Days With add-on Pain Medication
NCT00261495 (79) [back to overview]Resource Utilization of Pain Management
NCT00261495 (79) [back to overview]"Change From Baseline in Subject Diary Mean Pain Score for Pain at Its Worst From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24"
NCT00261495 (79) [back to overview]Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
NCT00261495 (79) [back to overview]Change From Baseline in QoL at Week 52
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality at Week 52
NCT00261495 (79) [back to overview]Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 24"
NCT00261495 (79) [back to overview]Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
NCT00261495 (79) [back to overview]Clinical Global Assessment of Efficacy
NCT00261495 (79) [back to overview]Mode and Convenience of Drug Intake.
NCT00261495 (79) [back to overview]Number of Drop-outs
NCT00261495 (79) [back to overview]Number of Subjects Indicating Optimal Sleep at Week 52
NCT00261495 (79) [back to overview]Number of Subjects Indicating That They Had Optimal Sleep at Week 24
NCT00261495 (79) [back to overview]Number of Subjects With Dose Escalation
NCT00261495 (79) [back to overview]Number of Subjects With Dose Escalation at Week 24 (ITT Population)
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Interference Score Interfered With General Activity (BPI Item 9a) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Pain Severity Pain at Its Least (BPI Item 4) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Pain Severity Pain at Its Worst (BPI Item 3) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Pain Severity Score Pain at Its Least (BPI Item 4) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Pain Severity Sub-score Pain at Its Worst (BPI Item 3) at Week 24 (ITT Population)"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Questionnaire Item 6 Pain Right Now Score at Week 24 (Intent to Treat [ITT] Population)"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Severity Score Pain Right Now (BPI Item 6) at Week 4"
NCT00261495 (79) [back to overview]Number of Subjects With Dose Escalation at Week 4 (ITT Population)
NCT00305058 (4) [back to overview]Number of Participants With a Change in Pain Score
NCT00305058 (4) [back to overview]Number of Participants With Pain Relief
NCT00305058 (4) [back to overview]Change in Pain Intensity
NCT00305058 (4) [back to overview]Number of Participants Satisfied With Pain Medication
NCT00305110 (6) [back to overview]Number of Participants Requiring Naloxone
NCT00305110 (6) [back to overview]Number of Participants Experiencing a Systolic Blood Pressure Less Than 90 mmHg
NCT00305110 (6) [back to overview]Number of Participants Experiencing a Respiratory Rate Lower Than 12 Breaths Per Minute
NCT00305110 (6) [back to overview]Oxygen Desaturation Measured Over 2-hour Time Frame
NCT00305110 (6) [back to overview]Oxygen Saturation Measured Over 2-hour Time Frame
NCT00305110 (6) [back to overview]Pain Intensity Assessed Over 2-hour Time Frame
NCT00385541 (5) [back to overview]Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale
NCT00385541 (5) [back to overview]Mean Score on the Ramsey Scale of Sedation
NCT00385541 (5) [back to overview]Nausea Assessment by Patient
NCT00385541 (5) [back to overview]Pain Assessment by Patient
NCT00385541 (5) [back to overview]The Number of Patients Who Vomited
NCT00465647 (4) [back to overview]Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)
NCT00465647 (4) [back to overview]Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time
NCT00465647 (4) [back to overview]Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]
NCT00465647 (4) [back to overview]Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time
NCT00499746 (8) [back to overview]Peak Change From Baseline Opioid Agonist Effects Assessed by the Visual Analog Scale (VAS)
NCT00499746 (8) [back to overview]Peak Change From Baseline Stimulant Effects Assessed by the Visual Analog Scale (VAS)
NCT00499746 (8) [back to overview]Physiologic Effects Assessed by the Pharmacological Class Questionnaire
NCT00499746 (8) [back to overview]Discrimination Effects Assessed by Discrete Choice
NCT00499746 (8) [back to overview]Discrimination Effects Assessed by Operant Responses
NCT00499746 (8) [back to overview]Physiological Effects Assessed by Peak Change From Baseline Pupil Diameter
NCT00499746 (8) [back to overview]Acquisition of Discrimination Assessed by Accuracy of the Discrimination Test
NCT00499746 (8) [back to overview]Discrimination Effects Assessed by Point Distribution
NCT00549042 (1) [back to overview]Change From Baseline to Week 12 in Mean Pain Intensity
NCT00627367 (4) [back to overview]Change in Numerical Rating Scale (NRS) Scores Among Patients Who Received 1 Dose of Intravenous (IV) Hydromorphone
NCT00627367 (4) [back to overview]Change in Numerical Rating Scale (NRS) Scores Among Patients in the Protocolized Group vs Those in the Physician Driven Group Who Received Only Intravenous (IV) Morphine
NCT00627367 (4) [back to overview]Patient Reported Change in Pain Intensity From Initial Administration of Analgesics (Baseline) to 60 Minutes Post-baseline.
NCT00627367 (4) [back to overview]Change in Numerical Rating Scale (NRS) Scores Among Patients Who Received 2 Doses of Intravenous (IV) Hydromorphone
NCT00631319 (1) [back to overview]Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase
NCT00682435 (4) [back to overview]Number of Patients With Reduction in Pain Intensity
NCT00682435 (4) [back to overview]Number of Patients Who Had Adequate Analgesia
NCT00682435 (4) [back to overview]Number of Patients With Oxygen Desaturation Less Than 95%
NCT00682435 (4) [back to overview]Change in Pain Intensity
NCT00766831 (13) [back to overview]Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain
NCT00766831 (13) [back to overview]Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score
NCT00766831 (13) [back to overview]Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug
NCT00766831 (13) [back to overview]Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain
NCT00766831 (13) [back to overview]Korean Brief Pain Inventory (K-BPI) Questionnaire Score
NCT00766831 (13) [back to overview]Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators
NCT00766831 (13) [back to overview]Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants
NCT00766831 (13) [back to overview]Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
NCT00766831 (13) [back to overview]Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain
NCT00766831 (13) [back to overview]Participant's Pain Intensity
NCT00766831 (13) [back to overview]Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug
NCT00766831 (13) [back to overview]Sleep Disturbance Questionnaire: Analgesic Administration
NCT00766831 (13) [back to overview]Sleep Disturbance Questionnaire: Frequency of Waking Up
NCT00825370 (4) [back to overview]Percentage of Patients With Successful Treatment
NCT00825370 (4) [back to overview]Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes
NCT00825370 (4) [back to overview]Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes
NCT00825370 (4) [back to overview]Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).
NCT00955110 (1) [back to overview]High VAS - Emax (mm)
NCT00980798 (2) [back to overview]The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event
NCT00980798 (2) [back to overview]Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average)
NCT01006356 (9) [back to overview]Pain Intensity Score
NCT01006356 (9) [back to overview]Frequency of Experiencing Breakthrough Pain
NCT01006356 (9) [back to overview]European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score
NCT01006356 (9) [back to overview]Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15
NCT01006356 (9) [back to overview]Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain
NCT01006356 (9) [back to overview]Global Assessment of Overall Efficacy of Study Drug by Investigator
NCT01006356 (9) [back to overview]Global Assessment of Overall Efficacy of Study Drug by Participant
NCT01006356 (9) [back to overview]Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
NCT01006356 (9) [back to overview]Participant's Preferences Along With Reasons
NCT01205126 (6) [back to overview]Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29
NCT01205126 (6) [back to overview]Breakthrough Pain Medication (Rescue Medication) Doses Taken
NCT01205126 (6) [back to overview]Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29
NCT01205126 (6) [back to overview]Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29
NCT01205126 (6) [back to overview]Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29
NCT01205126 (6) [back to overview]Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29
NCT01207596 (7) [back to overview]Global Assessment of Treatment Satisfaction
NCT01207596 (7) [back to overview]Sleep Quality Assessment (SQA)
NCT01207596 (7) [back to overview]Pain Quality Assessment Scale (PQAS)
NCT01207596 (7) [back to overview]Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #6: the Number That Tells How Much Pain You Have Right Now
NCT01207596 (7) [back to overview]Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #4: the Number That Best Describes Your Pain at Its Least in the Last 24 Hours
NCT01207596 (7) [back to overview]Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #3: the Number That Best Describes Your Pain at Its Worst in the Last 24 Hours
NCT01207596 (7) [back to overview]Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale
NCT01218984 (1) [back to overview]Slope Change From Baseline for Pupil Size
NCT01311895 (3) [back to overview]Number of Patients With Satisfactory Pain Management at 60 Minutes
NCT01311895 (3) [back to overview]Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes
NCT01311895 (3) [back to overview]Mean Change in Pain Intensity From Baseline to 60 Minutes
NCT01429285 (6) [back to overview]Number of Patients Who Achieved Satisfactory Analgesia at 15 Minutes Post-baseline
NCT01429285 (6) [back to overview]Number of Patients Who Achieved Satisfactory Analgesia at 60 Minutes Post-baseline
NCT01429285 (6) [back to overview]Mean Change in Pain Intensity From Baseline to 60 Minutes
NCT01429285 (6) [back to overview]Number of Patients With 50% or Greater Decline in Pain Intensity Score From Baseline to 60 Minutes
NCT01429285 (6) [back to overview]Pain Intensity Score at 60 Minutes
NCT01429285 (6) [back to overview]Number of Patients With a Pain Intensity Score of 3 or Less at 60 Minutes
NCT01429298 (5) [back to overview]Mean Change in Pain Intensity Score From Baseline to 30 Minutes
NCT01429298 (5) [back to overview]Number of Participants Who Achieved at Least 50% Decline in NRS Pain Score at 30 Minutes
NCT01429298 (5) [back to overview]Number of Participants Who Declined Additional Medication at 30 Minutes
NCT01429298 (5) [back to overview]Number of Participants Who Reported no Pain or Mild Pain at 30 Minutes
NCT01429298 (5) [back to overview]Number of Patients Who Achieved Absolute Pain Intensity Score of 3 or Less at 30 Minutes
NCT01455519 (13) [back to overview]Change in NRS After Treadmill Walk
NCT01455519 (13) [back to overview]Change in Treadmill Distance Walked
NCT01455519 (13) [back to overview]Change in Pain Disability
NCT01455519 (13) [back to overview]Change in Sit to Stand Repetitions
NCT01455519 (13) [back to overview]Change in Stair Climb Time
NCT01455519 (13) [back to overview]Change in Time to Lift Box
NCT01455519 (13) [back to overview]Change in VAS
NCT01455519 (13) [back to overview]Change in NRS After Stair Climb
NCT01455519 (13) [back to overview]Change in Distance to Floor
NCT01455519 (13) [back to overview]Change in McGill Pain Questionnaire - Short Form
NCT01455519 (13) [back to overview]Change in PASS
NCT01455519 (13) [back to overview]Change in NRS After Box Lift
NCT01455519 (13) [back to overview]Change in NRS After Sit to Stand Repetitions
NCT01591382 (5) [back to overview]Number of Participants With Treatment Related Adverse Events (AEs)
NCT01591382 (5) [back to overview]Worst Postoperative Pain Score
NCT01591382 (5) [back to overview]Average Postoperative Pain Score
NCT01591382 (5) [back to overview]24-Hour Postoperative Opioid Use
NCT01591382 (5) [back to overview]Least Postoperative Pain Score
NCT01598506 (2) [back to overview]Pain Score, Visual Analogue Pain Scores
NCT01598506 (2) [back to overview]Pain Scores, Visual Analogue Pain Scale
NCT01598545 (5) [back to overview]Pain Scores, Visual Analogue Pain Scale
NCT01598545 (5) [back to overview]Pain Scores, Visual Analogue Pain Scale
NCT01598545 (5) [back to overview]Pain Scores, Visual Analogue Pain Scale
NCT01598545 (5) [back to overview]Pain Scores, Visual Analogue Pain Scale
NCT01598545 (5) [back to overview]Pain Scores, Visual Analogue Pain Scale
NCT01648699 (4) [back to overview]Brief Pain Inventory (BPI) Average Score at Baseline
NCT01648699 (4) [back to overview]Number of Participants Given Rescue Pain Medications
NCT01648699 (4) [back to overview]Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
NCT01648699 (4) [back to overview]Brief Pain Inventory (BPI) Average Score at Day 28
NCT01675778 (19) [back to overview]Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment
NCT01675778 (19) [back to overview]Number of Participants Who Desired for More Analgesics
NCT01675778 (19) [back to overview]Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment
NCT01675778 (19) [back to overview]Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity
NCT01675778 (19) [back to overview]Number of Participants With Oxygen Saturation Level < 92%
NCT01675778 (19) [back to overview]Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity
NCT01675778 (19) [back to overview]Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity
NCT01675778 (19) [back to overview]Number of Participant With Systolic Blood Pressure < 90 mmHg
NCT01675778 (19) [back to overview]Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity
NCT01675778 (19) [back to overview]Pain Treatment Satisfaction Levels as Assessed by Self-report
NCT01675778 (19) [back to overview]Effect of Gender on the Correlation Between BMI and Change in Pain Intensity
NCT01675778 (19) [back to overview]Number of Participants With Vomit
NCT01675778 (19) [back to overview]Number of Participants With Skin Itching
NCT01675778 (19) [back to overview]Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity
NCT01675778 (19) [back to overview]Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment
NCT01675778 (19) [back to overview]Number of Participants With Nausea
NCT01675778 (19) [back to overview]Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment
NCT01675778 (19) [back to overview]Effect of Gender on the Correlation Between TBW and Change in Pain Intensity
NCT01675778 (19) [back to overview]Effects of Age on the Correlation Between TBW and Change in Pain Intensity
NCT01709721 (10) [back to overview]Patient Global Impression of Change (PGIC)
NCT01709721 (10) [back to overview]Proportion of Subjects Who Are Treatment Failures During the Double-blind Randomized Withdrawal Period
NCT01709721 (10) [back to overview]Short-Form McGill Pain Questionnaire (SF-MPQ): Summary Score
NCT01709721 (10) [back to overview]Time to Rescue - Rescue Medication Given
NCT01709721 (10) [back to overview]Time to Rescue Medication After Randomization (Days)
NCT01709721 (10) [back to overview]Brief Pain Inventory (BPI): Pain Severity Summary Measure
NCT01709721 (10) [back to overview]"Brief Pain Inventory (BPI): Pain Severity Average"
NCT01709721 (10) [back to overview]"Brief Pain Inventory (BPI): Pain Severity, Worst"
NCT01709721 (10) [back to overview]Brief Pain Inventory: Interference With Function Summary Measure
NCT01709721 (10) [back to overview]Oral Opioid Supplement Consumption
NCT01709747 (3) [back to overview]Patient Global Impression of Change (PGIC)
NCT01709747 (3) [back to overview]Brief Pain Inventory (BPI) - Mean Pain Severity
NCT01709747 (3) [back to overview]Visual Analog Scale Pain Intensity (VASPI)
NCT01812759 (1) [back to overview]Number of Participants With Total Pain Relief Score (TOTPAR4) at Four Hours After Treatment Initiation.
NCT01892709 (4) [back to overview]"Number of Patients Responding to the Question, Do You Want More Pain Medication? at Each Time Point"
NCT01892709 (4) [back to overview]Number of Participants Requesting Pain Medication in Different Patterns Over Time
NCT01892709 (4) [back to overview]Adverse Events and Side Effects by Total Amount of Hydromorphone Received
NCT01892709 (4) [back to overview]"Mean Pain Intensity Score in Numerical Rating Scale (NRS) Units at Each Time Point, Based on Response to the Question, Do You Want More Pain Medication?"
NCT01943565 (8) [back to overview]Number of Patients With Hypothermia (Body Temperature < 95F/35C)
NCT01943565 (8) [back to overview]Intraoperative Vasopressor Use: Phenylephrine Equivalents
NCT01943565 (8) [back to overview]Intraoperative Vasopressor Use: Ephedrine Equivalents
NCT01943565 (8) [back to overview]24hr Post-partum IV Opioid Requirement
NCT01943565 (8) [back to overview]Number of Patients With Pruritus
NCT01943565 (8) [back to overview]Patients With Nausea and Vomiting Requiring Rescue Medication
NCT01943565 (8) [back to overview]Number of Patients With Visual Disturbances
NCT01943565 (8) [back to overview]Oxygen Saturation, Need for Supplemental Oxygen
NCT01986946 (11) [back to overview]Number of Participants Experiencing Delirium
NCT01986946 (11) [back to overview]Number of Participants Experiencing Delirium
NCT01986946 (11) [back to overview]Number of Participants Experiencing Delirium
NCT01986946 (11) [back to overview]Length of Hospital Stay
NCT01986946 (11) [back to overview]Patient Satisfaction With Perioperative Analgesia
NCT01986946 (11) [back to overview]Patient Satisfaction With Perioperative Analgesia
NCT01986946 (11) [back to overview]Total Post-operative Opioid Consumption
NCT01986946 (11) [back to overview]Patient Satisfaction With Overall Care
NCT01986946 (11) [back to overview]Number of Participants With Adverse Events Related to the Study
NCT01986946 (11) [back to overview]Post-operative Pain as Assessed by Visual Analogue Scale (VAS)
NCT01986946 (11) [back to overview]Number of Participants Readmitted to Hospital Within 30 Days of Surgery
NCT02009722 (10) [back to overview]Pruritus
NCT02009722 (10) [back to overview]Treatment for Pruritus
NCT02009722 (10) [back to overview]Side Effects: Nausea
NCT02009722 (10) [back to overview]Side Effects: Pruritus
NCT02009722 (10) [back to overview]Side Effects: Sedation
NCT02009722 (10) [back to overview]Treatment for Nausea
NCT02009722 (10) [back to overview]Dose of IT Morphine and IT Hydromorphone for Adequate Analgesia (Pain Score Less Than or Equal to 3) in 90% of Patients
NCT02009722 (10) [back to overview]Nausea
NCT02009722 (10) [back to overview]Nausea
NCT02009722 (10) [back to overview]Pruritus
NCT02044094 (20) [back to overview]Reinforcing Effects (Breakpoint) by Study Week Analyzed by Mixed Model for Repeated Measures
NCT02044094 (20) [back to overview]"Change From Placebo in VAS Score for Do You Feel Any Drug Effect? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"
NCT02044094 (20) [back to overview]"Change From Placebo in VAS Score for Do You Feel Sedated? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"
NCT02044094 (20) [back to overview]Reinforcing Effects Of the Daily Randomized Hydromorphone Challenge as Measured by the Mean Hydromorphone Break Point Value at Weeks 1-12
NCT02044094 (20) [back to overview]"Change From Placebo in VAS Score for Does the Drug Have Any Bad Effects? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"
NCT02044094 (20) [back to overview]"VAS Score for Do You Feel Any Drug Effect? by Study Week Analyzed by Mixed Model for Repeated Measures"
NCT02044094 (20) [back to overview]"Change From Placebo in VAS Score for Does the Drug Have Any Good Effects? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"
NCT02044094 (20) [back to overview]"Change From Placebo in VAS Score for How High Are You Right Now? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"
NCT02044094 (20) [back to overview]"Opioid Blockade Following Administration of Hydromorphone Challenge As Measured Using the Subjective Opioid Effects Rating for the Question Do You Like the Drug? Visual Analog Scale (VAS) at Weeks 1-4 Analyzed by Mixed Model for Repeated Measures"
NCT02044094 (20) [back to overview]"VAS Score for Do You Feel Sedated? by Study Week Analyzed by Mixed Model for Repeated Measures"
NCT02044094 (20) [back to overview]"VAS Score for Does the Drug Have Any Bad Effects? by Study Week Analyzed by Mixed Model for Repeated Measures"
NCT02044094 (20) [back to overview]"VAS Score for Does the Drug Have Any Good Effects? by Study Week Analyzed by Mixed Model for Repeated Measures"
NCT02044094 (20) [back to overview]"VAS Score for How High Are You Right Now? by Study Week Analyzed by Mixed Model for Repeated Measures"
NCT02044094 (20) [back to overview]"Visual Analog Scale (VAS) Score for Do You Like the Drug? by Study Week Analyzed by Mixed Model for Repeated Measures"
NCT02044094 (20) [back to overview]Change From Placebo in Reinforcing Effects (Breakpoint) by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)
NCT02044094 (20) [back to overview]Participants With Treatment-Emergent Adverse Events (TEAE)
NCT02044094 (20) [back to overview]Participants With Treatment-Emergent Adverse Events (TEAE)
NCT02044094 (20) [back to overview]Plasma Concentrations of Buprenorphine Summarized by Study Week
NCT02044094 (20) [back to overview]"Change From Placebo in VAS Score for Do You Like the Drug? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"
NCT02044094 (20) [back to overview]Predicted mu Opioid Receptor Occupancy (μORO) by Mean Buprenorphine Concentrations and Study Week
NCT02056301 (3) [back to overview]Verbal Pain Scale Scores During Postoperative Days 0-4
NCT02056301 (3) [back to overview]Total Morphine Equivalent Consumption During Postoperative Days 0-4
NCT02056301 (3) [back to overview]Rescue Morphine Equivalent Administration During Postoperative Days 0-4
NCT02062879 (3) [back to overview]Median Pain Score
NCT02062879 (3) [back to overview]Total Daily Opioid Requirement
NCT02062879 (3) [back to overview]Breakthrough Daily Opioid Requirement
NCT02096003 (4) [back to overview]Post Operative Fentanyl PCA Consumption
NCT02096003 (4) [back to overview]Pain Score
NCT02096003 (4) [back to overview]Patient Satisfaction Score
NCT02096003 (4) [back to overview]Symptom Scale for Two Specific Side Effects of Nausea and Pruritus
NCT02107339 (16) [back to overview]Chronic Persistent Surgical Pain-Weekly Frequency of Pain
NCT02107339 (16) [back to overview]Pain Scores Postanesthesia Care Unit (PACU) Arrival
NCT02107339 (16) [back to overview]Pain Scores on Postoperative Day One
NCT02107339 (16) [back to overview]Pain Scores on Postoperative Day 2
NCT02107339 (16) [back to overview]Pain Scores 2 Hours After PACU Arrival
NCT02107339 (16) [back to overview]Pain Scores 1 Hour After PACU Arrival
NCT02107339 (16) [back to overview]Hydromorphone Use Third 24 Hours
NCT02107339 (16) [back to overview]Hydromorphone Use Second 24 Hours
NCT02107339 (16) [back to overview]Hydromorphone Use at 24 Hours
NCT02107339 (16) [back to overview]Chronic Persistent Surgical Pain-weekly Frequency of Pain
NCT02107339 (16) [back to overview]Chronic Persistent Surgical Pain-Weekly Frequency of Pain
NCT02107339 (16) [back to overview]Patient Satisfaction Scores
NCT02107339 (16) [back to overview]Chronic Persistent Surgical Pain-Weekly Frequency of Pain
NCT02107339 (16) [back to overview]Pain Scores Postoperative Day 3
NCT02107339 (16) [back to overview]Patient Satisfaction Scores
NCT02107339 (16) [back to overview]Patient Satisfaction Scores
NCT02164929 (8) [back to overview]Time to First Ingestion of Solid Food
NCT02164929 (8) [back to overview]Length of Stay
NCT02164929 (8) [back to overview]Number of Epidural-related Side Effects
NCT02164929 (8) [back to overview]Opioid Related Side Effects
NCT02164929 (8) [back to overview]Pain Scores
NCT02164929 (8) [back to overview]Postoperative Opioid Consumption
NCT02164929 (8) [back to overview]Quality of Recovery
NCT02164929 (8) [back to overview]Time to First Bowel Movement
NCT02205983 (1) [back to overview]"Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire"
NCT02222246 (2) [back to overview]Change in Pain Visual Analogue Scale (VAS) Scores Over Time
NCT02222246 (2) [back to overview]Difference in Pain Score as Measured by a Visual Analogue Scale (VAS)
NCT02223377 (9) [back to overview]Severe Sedation
NCT02223377 (9) [back to overview]Time to Discharge From Hospital
NCT02223377 (9) [back to overview]Time to Discharge From PACU
NCT02223377 (9) [back to overview]Mean Dose of Analgesic Used
NCT02223377 (9) [back to overview]Number of Patients With Severe Itching
NCT02223377 (9) [back to overview]Our Combined Primary Outcome Will be Number of Patients With Same Analgesia Minimal Emesis, as Compared Between the 2 Groups.
NCT02223377 (9) [back to overview]Patients Requesting Oral Analgesia in the Day Surgery Unit
NCT02223377 (9) [back to overview]Patient Satisfaction Score
NCT02223377 (9) [back to overview]Severe Respiratory Depression
NCT02321319 (1) [back to overview]Number of Participants With Adverse Events (AEs)
NCT02356198 (5) [back to overview]Mean Pain Score
NCT02356198 (5) [back to overview]Number of Participants With Post-operative Ileus
NCT02356198 (5) [back to overview]Total Length of Hospital Stay
NCT02356198 (5) [back to overview]Total Morphine Milligram Equivalents Use (MME)
NCT02356198 (5) [back to overview]Use of Intravenous Patient-controlled Analgesia
NCT02389829 (4) [back to overview]Number of Participants Needing Rescue Medication as Assessed by Questionnaire
NCT02389829 (4) [back to overview]Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire
NCT02389829 (4) [back to overview]Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
NCT02389829 (4) [back to overview]Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire
NCT02423876 (12) [back to overview]Number of Recorded Episodes of Emesis
NCT02423876 (12) [back to overview]Patient Satisfaction Scores Related to Pain Metrics, as Measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey
NCT02423876 (12) [back to overview]Post-operative Antiemetic Use (Measured in mg of Ondanestron Used in the First 24 Hours After Surgery)
NCT02423876 (12) [back to overview]Post-operative Complications (UTIs, Thromboembolic Events, Pneumonia, Blood Transfusion, Myocardial Infarction, Falls)
NCT02423876 (12) [back to overview]Average Daily Pain Score as Measured by Pain NRS Scores
NCT02423876 (12) [back to overview]Length of Time Until Return of Bowel Function
NCT02423876 (12) [back to overview]Difference in IL-2 Levels Between Pre-operative and Post-operative Values
NCT02423876 (12) [back to overview]Epidural Discontinuation Rates Prior to Planned Removal (in Epidural Group Only)
NCT02423876 (12) [back to overview]Total Opioid Use Measured in Oral Morphine Equivalents (mg)
NCT02423876 (12) [back to overview]Length of Hospital Stay (Hours)
NCT02423876 (12) [back to overview]Relative Pain Scores, as Measured by the Pain Numeric Rating Scale (NRS)
NCT02423876 (12) [back to overview]Readmission Rate
NCT02437669 (4) [back to overview]Score on Verbal Numeric Rating Scale
NCT02437669 (4) [back to overview]Score on Faces Pain Scale - Revised
NCT02437669 (4) [back to overview]Number of Minor Adverse Events
NCT02437669 (4) [back to overview]Number of Major Adverse Events
NCT02459964 (2) [back to overview]Non-inferiority of Fentanyl Nasal Spray Versus Intravenous Opioids in the Change in the Numeric Rating Scale (NRS) Pain Intensity Score at One Hour, Starting From the Time of Drug Delivery (Treatment Initiation).
NCT02459964 (2) [back to overview]Number of Participants With Change in Numeric Rating Scale (NRS) Pain Intensity Score
NCT02601027 (6) [back to overview]Post-operative Narcotic Usage
NCT02601027 (6) [back to overview]Quality of Life Measurement
NCT02601027 (6) [back to overview]Time to First Bowel Movement
NCT02601027 (6) [back to overview]Time to Ambulation
NCT02601027 (6) [back to overview]Post-operative Pain Score
NCT02601027 (6) [back to overview]Post-operative Anti-emetic Usage
NCT02604589 (7) [back to overview]Narcotic Use
NCT02604589 (7) [back to overview]Mortality
NCT02604589 (7) [back to overview]Surgical Intensive Care Unit (SICU) Length of Stay
NCT02604589 (7) [back to overview]Time to Improvement in Pain Intensity
NCT02604589 (7) [back to overview]Time to Improvement in Pulmonary Function
NCT02604589 (7) [back to overview]Morbidity
NCT02604589 (7) [back to overview]Hospital Length of Stay
NCT02621619 (2) [back to overview]Change in Pain Intensity Over Time
NCT02621619 (2) [back to overview]Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused
NCT02625181 (4) [back to overview]The Number of Prophylactic Interventions for PONV
NCT02625181 (4) [back to overview]Adherence to PONV Guidelines
NCT02625181 (4) [back to overview]PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting
NCT02625181 (4) [back to overview]Time to Discharge From the Postanesthesia Care Unit (PACU)
NCT02789410 (3) [back to overview]Pruritus
NCT02789410 (3) [back to overview]NRS Score for Pain (0-10) With Movement 24 Hours After Spinal Administration
NCT02789410 (3) [back to overview]Nausea
NCT02886286 (6) [back to overview]Change From Baseline in Average Weekly Numeric Pain Rating Score (NRS)
NCT02886286 (6) [back to overview]Change From Baseline in Oswestry Disability Index (ODI)
NCT02886286 (6) [back to overview]Change From Baseline in painDETECT
NCT02886286 (6) [back to overview]Change From Baseline in Patient Global Impression of Change (PGIC)
NCT02886286 (6) [back to overview]Change From Baseline in the Numerical Rating Pain Scale (NRS)
NCT02886286 (6) [back to overview]Change From Baseline in Treatment Satisfaction
NCT03052816 (10) [back to overview]Length of Stay
NCT03052816 (10) [back to overview]Total Dose of Opioids Administered During Hospitalization
NCT03052816 (10) [back to overview]Satisfaction Scores in the Morning After Surgery (7AM)
NCT03052816 (10) [back to overview]VAS Scores at 4 Hours Post Surgery
NCT03052816 (10) [back to overview]Satisfaction Scores 96 Hours After Surgery
NCT03052816 (10) [back to overview]Postoperative Nausea and Vomiting at 7AM After Surgery
NCT03052816 (10) [back to overview]Quality of Recovery Scores on Post op Day 1
NCT03052816 (10) [back to overview]Visual Analog Scores (VAS)
NCT03052816 (10) [back to overview]VAS Scores 96 Hours After Surgery
NCT03052816 (10) [back to overview]Number of Participants With Urinary Retention.
NCT03104816 (1) [back to overview]Postoperative Opioid Use
NCT03115151 (1) [back to overview]Visual Analog Pain Score (VAS)
NCT03151434 (7) [back to overview]Average Sedation Scores Over 72 Hours
NCT03151434 (7) [back to overview]Average Nausea Scores Over 72 Hours
NCT03151434 (7) [back to overview]Subjects Overall Satisfaction Scores
NCT03151434 (7) [back to overview]The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours
NCT03151434 (7) [back to overview]The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours
NCT03151434 (7) [back to overview]Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours
NCT03151434 (7) [back to overview]Subjects Overall Satisfaction Scores
NCT03300674 (3) [back to overview]Change in 0-10 Pain Scale Between Baseline and 90 Minutes
NCT03300674 (3) [back to overview]Adverse Events
NCT03300674 (3) [back to overview]Rescue Medication
NCT03389750 (1) [back to overview]"Positive Subjective Drug Effects (i.e., Drug Liking)."
NCT03521102 (3) [back to overview]Clinical Improvement in NRS Pain Score
NCT03521102 (3) [back to overview]Improvement in NPS Pain Score by >=50%
NCT03521102 (3) [back to overview]Need for Rescue Medication
NCT03553498 (4) [back to overview]Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment
NCT03553498 (4) [back to overview]Percentage of Patients Who Want Additional Analgesics
NCT03553498 (4) [back to overview]Percentage of Patients Who Received Additional Pain Medication Within 60 Minutes of Administration of Study Medication
NCT03553498 (4) [back to overview]Percentage of Patients Who Received Additional Pain Medication Between 61 and 120 Minutes After Administration of Study Medications
NCT03789318 (5) [back to overview]Time to Opioid Cessation or Freedom
NCT03789318 (5) [back to overview]Total Opioid Consumption
NCT03789318 (5) [back to overview]Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores
NCT03789318 (5) [back to overview]Pain Intensity Scores at 96 Hours at Rest Using Numerical Rating Scale (NRS)
NCT03789318 (5) [back to overview]Percent of Opioid Free Subjects
NCT03933397 (5) [back to overview]Length of Care
NCT03933397 (5) [back to overview]Length of Index ED (Emergency Department) Stay
NCT03933397 (5) [back to overview]The Change in Pain Score
NCT03933397 (5) [back to overview]Number of Participants Experiencing Side Effects
NCT03933397 (5) [back to overview]Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment
NCT04429022 (8) [back to overview]Pain Scores
NCT04429022 (8) [back to overview]Length of Stay in Hours
NCT04429022 (8) [back to overview]Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period
NCT04429022 (8) [back to overview]Operative Time
NCT04429022 (8) [back to overview]Pain Scores
NCT04429022 (8) [back to overview]Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)
NCT04429022 (8) [back to overview]Total Opioid Pain Medications Required Through 3-24h Post op in MME
NCT04429022 (8) [back to overview]Estimated Blood Loss

"Change From Baseline in QoL Vitality at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl6.4
Oxycodone9.2

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Change in Dose of Study Treatment

Number of subjects with change in dose of study treatment was assessed at weeks 4, 24, and 52. (NCT00261495)
Timeframe: weeks 4, 24, and 52

,
InterventionSubjects (Number)
0 mg (week 4)+8 mg (week 4)+20 mg (week 4)+24 mg (week 4)+60 mg (week 4)-60 mg (week 24)-40 mg (week 24)-24 mg (week 24)-20 mg (week 24)-16 mg (week 24)-8 mg (week 24)0 mg (week 24)+8 mg (week 24)+16 mg (week 24)+20 mg (week 24)+40 mg (week 24)-16 mg (week 52)-8 mg (week 52)0 mg (week 52)+40 mg (week 52)
OROS Hydromorphone HCl7910207300010411172690031560
Oxycodone8401080582806001440081400502

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"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 4"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g pain interfered with enjoyment of life at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = interferes completely. Negative change from baseline scores indicate improvement in pain interfered with enjoyment of life." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.6
Oxycodone-1.9

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"Change From Baseline in Pain Interference Pain Interfered With General Activity (BPI Item 9a) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9a pain interfered with general activity at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with general activity." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.6
Oxycodone-1.6

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"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b pain interfered with mood at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with mood." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.4
Oxycodone-1.3

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"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 4"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b pain interfered with mood at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with mood." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.7
Oxycodone-1.9

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"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d pain interfered with normal work at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with normal work." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.3
Oxycodone-1.4

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"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 4"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d pain interfered with normal work at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with normal work." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.4
Oxycodone-2.0

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"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9e pain interfered with relations with other people at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with relations with other people." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-0.7
Oxycodone-0.9

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"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 4"

"Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9e pain interfered with relations with other people at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with relations with other people." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.1
Oxycodone-1.4

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"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9f pain interfered with sleep at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with sleep." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.4
Oxycodone-1.5

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"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 4"

"Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9f pain interfered with sleep at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 - completely interferes. Negative change from baseline scores indicate improvement in pain interfered with sleep." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-2.1
Oxycodone-2.3

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"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c pain interfered with walking ability at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with walking ability." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.1
Oxycodone-1.2

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"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 4"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c pain interfered with walking ability at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with walking ability." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.2
Oxycodone-1.5

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"Change From Baseline in QoL Bodily Pain at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 bodily pain index score at week 24. Score could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl10.6
Oxycodone11.9

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"Change From Baseline in QoL General Health Perceptions at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in health perceptions. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl2.1
Oxycodone2.2

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"Change From Baseline in QoL General Health Perceptions at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in general health perceptions. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl3.9
Oxycodone5.0

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"Change From Baseline in QoL Health Transition at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in health transition. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-0.2
Oxycodone-0.1

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"Change From Baseline in QoL Health Transition at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 4. Scores could range from 0 to 100, with higher scores indicating a better QoL. Positive change from baseline scores indicate improvement in health transition. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-0.4
Oxycodone-0.5

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"Change From Baseline in QoL Mental Health at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in mental health score. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl6.2
Oxycodone6.6

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"Change From Baseline in QoL Mental Health at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline score indicates improvement in mental health. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl2.6
Oxycodone2.6

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"Change From Baseline in QoL Physical Functioning at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl7.7
Oxycodone4.4

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"Change From Baseline in QoL Physical Functioning at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 4. Scores could range from 0 to 100, with high scores indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl8.7
Oxycodone5.4

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"Change From Baseline in QoL Role Emotional at Week 24"

"Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role emotional score at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in role emotional." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl0.40
Oxycodone-1.5

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"Change From Baseline in QoL Role Emotional at Week 4"

"Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role emotional score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role emotional." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl9.9
Oxycodone4.7

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"Change From Baseline in QoL Role Physical at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl8.8
Oxycodone9.9

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"Change From Baseline in QoL Role Physical at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl13.2
Oxycodone16.9

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"Change From Baseline in QoL Social Functioning at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl6.6
Oxycodone5.0

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"Change From Baseline in QoL Social Functioning at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl10.5
Oxycodone12.9

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"Change From Baseline in QoL Vitality at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl4.3
Oxycodone5.6

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"Change From Baseline in Quality of Life (QoL) Bodily Pain at Week 4"

Change from baseline in QoL was assessed using the Short Form (SF)-36 QoL questionnaire, specifically the SF-36 bodily pain index. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl13.7
Oxycodone16.7

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"Change From Baseline in Subject Diary Evening Mean Pain Score Pain Right Now at Week 24"

"Change from baseline to week 24 in subject diary evening mean pain score pain right now. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score pain right now." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-2.2
Oxycodone-2.0

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"Change From Baseline in Subject Diary Morning Mean Pain Score Pain Right Now at Week 24"

"Change from baseline to week 24 in subject diary morning mean pain score pain right now. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score pain right now." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-2.0
Oxycodone-2.0

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Amount of add-on Pain Medication

Total amount of add-on pain medication (paracetamol) for the first 24 weeks was assessed at week 24. (NCT00261495)
Timeframe: 24 weeks

Interventionmg (Mean)
OROS Hydromorphone HCl80004.8
Oxycodone76191.9

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Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24

Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 24. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl8.6
Oxycodone11.5

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Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4

Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 4. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl13.8
Oxycodone15.2

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Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24

Change in pain severity was assessed using the BPI questionnaire, specifically average (mean) score of BPI items 3 to 6 (worst pain, least pain, average pain, and pain right now) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative scores indicate improvement in pain severity. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.6
Oxycodone-1.7

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Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4

Change from baseline in BPI pain severity was assessed using the BPI questionnaire (mean of BPI items 3 to 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain severity. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.7
Oxycodone-2.0

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Change From Baseline in Sleep Quality (MOS Index I) at Week 4

Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items; MOS sleep scale index I (average of item 1, 3, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-10.6
Oxycodone-8.7

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"Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 Pain Right Now Score at Week 24 (Per Protocol [PP] Population)"

"Assessment of non-inferiority of OROS hydromorphone compared with sustained release (SR) oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 pain right now score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-2.8
Oxycodone-3.2

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Change From Baseline in Sleep Quality (MOS Index II) at Week 24

Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-8.9
Oxycodone-6.5

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Change From Baseline in Sleep Quality (MOS Index II) at Week 4

Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-10.5
Oxycodone-9.0

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Change From Baseline in Sleep Quality at Week 24

Change from baseline in sleep quality was assessed using the Medical Outcomes Study (MOS) questionnaire at week 24, specifically the sleep subscale index I. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improved sleep quality. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-8.8
Oxycodone-6.2

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Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24

Change from baseline in sleep quality (sleep adequacy) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep adequacy. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl9.1
Oxycodone7.3

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Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24

Change from baseline in sleep quality (sleep disturbance) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep disturbance. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-13.1
Oxycodone-11.7

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Change From Baseline in Sleep Quality, Sleep Quantity at Week 24

Change from baseline in sleep quality (sleep quantity) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep quantity. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl0.4
Oxycodone0.5

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Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24

Change from baseline in sleep quality (sleep shortness of breath or headache) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep shortness of breath or headache. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-5.3
Oxycodone-0.1

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Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24

Change from baseline in sleep quality (sleep somnolence) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep somnolence. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.6
Oxycodone3.0

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Change From Baseline in Sleep Quality, Snoring at Week 24

Change from baseline in sleep quality (snoring) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in snoring. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.0
Oxycodone-4.1

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Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)

If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively. (NCT00261495)
Timeframe: week 24

Interventionmg per day (Mean)
OROS Hydromorphone HCl18.4
Oxycodone43.8

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Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)

If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively. (NCT00261495)
Timeframe: week 24

Interventionmg per day (Mean)
OROS Hydromorphone HCl18.9
Oxycodone48.3

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Equi-analgesic Dose at Steady State (ITT Population)

Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24. (NCT00261495)
Timeframe: week 4 to week 24

Interventionmg per day (Mean)
OROS Hydromorphone HCl19.50
Oxycodone48.41

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Equi-analgesic Dose at Steady-state (PP Population)

Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24. (NCT00261495)
Timeframe: week 4 to week 24

Interventionmg per day (Mean)
OROS Hydromorphone HCl18.95
Oxycodone47.82

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Number of Days With add-on Pain Medication

Number of days with add-on pain medication during the first 24 weeks of the study was assessed at week 24. (NCT00261495)
Timeframe: week 24

InterventionDays (Mean)
OROS Hydromorphone HCl68.2
Oxycodone66.1

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Resource Utilization of Pain Management

Resource utilization was defined as the number of additional visits including additional telephone visits during the treatment period. This was assessed at week 24. (NCT00261495)
Timeframe: week 24

InterventionAdditional visits (Mean)
OROS Hydromorphone HCl2.1
Oxycodone1.9

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"Change From Baseline in Subject Diary Mean Pain Score for Pain at Its Worst From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24"

"Change from baseline in subject diary mean pain score pain at its worst from morning to evening at weeks 4, 8, 12, 16, 20, and 24. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain score pain at its worst." (NCT00261495)
Timeframe: baseline and weeks 4, 8, 12, 16, 20, and 24

,
InterventionUnits on a scale (Mean)
BaselineWeek 4Week 8Week 12Week 16Week 20Week 24
OROS Hydromorphone HCl0.70.50.40.30.20.30.3
Oxycodone0.40.40.40.30.20.20.3

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Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)

Change from baseline in pain severity, pain relief, and pain interference was assessed using the BPI questionnaire at week 52. BPI items 3 to 6, score range 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine; BPI items 9a to 9g, score range from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain severity and pain interference. BPI item 8, score range from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief. (NCT00261495)
Timeframe: baseline and week 52

,
InterventionUnits on a scale (Mean)
Pain severity, BPI items 3 to 6Pain relief, BPI item 8Pain right now, BPI item 6Pain at its worst, BPI item 3Pain at its least, BPI item 4Average pain, BPI item 5Pain interfered general activity, BPI item 9aPain interfered mood, BPI item 9bPain interfered walking ability, BPI item 9cPain interfered normal work, BPI item 9dPain interfered relation other people, BPI item 9eBPI pain interfered sleep, BPI item 9fBPI pain interfered enjoyment of life, BPI item 9g
OROS Hydromorphone HCl-2.417.7-2.9-2.8-1.9-2.6-2.5-2.3-2.3-2.9-1.6-2.4-2.4
Oxycodone-2.423.6-2.8-2.4-2.3-2.6-2.6-2.7-2.5-3.2-1.9-3.0-2.6

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Change From Baseline in QoL at Week 52

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire at week 52. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in QoL. (NCT00261495)
Timeframe: baseline and week 52

,
InterventionUnits on a scale (Mean)
SF-36 bodily pain indexSF-36 general health perceptionsSF-36 health transitionSF-36 mental healthSF-36 physical functioningSF-36 role emotionalSF-36 role physicalSF-36 social functioningSF-36 vitality
OROS Hydromorphone HCl23.19.6-0.311.711.422.117.015.411.5
Oxycodone19.65.5-0.16.99.27.315.012.811.9

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Change From Baseline in Sleep Quality at Week 52

Change from baseline in sleep quality was assessed using the MOS questionnaire at week 52. Score range 0 to 100. For disturbance, snoring, shortness of breath or headache, and somnolence, 0 = best sleep quality and 100 = worst sleep quality; negative change from baseline scores indicate improvement in sleep quality for these measures. For adequacy and quantity, 0 = worst sleep quality and 100 = best sleep quality; positive change from baseline scores indicate improvement in sleep quality for these measures. (NCT00261495)
Timeframe: baseline and week 52

,
InterventionUnits on a scale (Mean)
MOS sleep disturbanceMOS snoringMOS sleep shortness of breath or headacheMOS sleep adequacyMOS sleep somnolenceMOS sleep quantity
OROS Hydromorphone HCl-17.6-2.5-8.412.3-6.50.5
Oxycodone-20.1-4.7-7.811.91.80.5

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Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24

Change from baseline to week 24 in subject diary evening, morning and all day mean pain scores for pain right now, at its worst, at its least, and average. Subjects rated the severity of pain on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain scores. (NCT00261495)
Timeframe: baseline and week 24

,
InterventionUnits on a scale (Mean)
Evening worst painEvening least painEvening average painMorning worst painMorning least painMorning average painAll day worst painAll day least painAll day average painAll day pain right now
OROS Hydromorphone HCl-2.2-1.6-2.0-1.9-1.5-1.7-2.1-1.5-1.8-2.1
Oxycodone-2.1-1.4-1.8-2.1-1.2-1.8-2.1-1.3-1.8-2.0

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"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g pain interfered with enjoyment of life at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with enjoyment of life." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.2
Oxycodone-1.3

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Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)

Number of subejcts with change in dose of study treatment was assessed and stratified by time on study, at least 4 weeks versus dropped out at highest dose before week 4, at weeks 4 and 24. (NCT00261495)
Timeframe: weeks 4 and 24

,
InterventionSubjects (Number)
Titration phase (on study at least 4 weeks) 0 mgTitration phase (on study at least 4 weeks) +8 mgTitration phase (on study at least 4 weeks) +20 mgTitration phase (on study at least 4 weeks) +24 mgTitration phase (on study at least 4 weeks) +60 mgTitration phase (on study <4 weeks) 0 mgTitration phase (on study <4 weeks) +8 mgTitration phase (on study <4 weeks) +20 mgTitration phase (on study <4 weeks) +24 mgTitration phase (on study <4 weeks) +60 mgWeek 24 (on study at least 4 weeks) 0 mgWeek 24 (on study at least 4 weeks ) +4 mgWeek 24 (on study at least 4 weeks ) +8 mgWeek 24 (on study at least 4 weeks) +20 mgWeek 24 (on study at least 4 weeks ) +24 mgWeek 24 (on study at least 4 weeks) +60 mgWeek 24 (on study <4 weeks) 0 mgWeek 24 (on study <4 weeks) +8 mgWeek 24 (on study <4 weeks) +20 mgWeek 24 (on study <4 weeks) +24 mgWeek 24 (on study <4 weeks) +60 mg
OROS Hydromorphone HCl5092065029100805807607302910080
Oxycodone4109405443014044010870614301404

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Clinical Global Assessment of Efficacy

Overall clinical efficacy was assessed by the Investigator using the following global ratings: very good, good, moderate, poor, or very poor, at weeks 4, 24, and 52. (NCT00261495)
Timeframe: weeks 4, 24, and 52

,
InterventionSubjects (Number)
Visit 5, week 4: very goodVisit 5, week 4: goodVisit 5, week 4: moderateVisit 5, week 4: poorVisit 5, week 4: very poorVisit 8, week 24: very goodVisit 8, week 24: goodVisit 8, week 24: moderateVisit 8, week 24: poorVisit 8, week 24: very poorVisit 10, week 52: very goodVisit 10, week 52: goodVisit 10, week 52: moderateVisit 10, week 52: poorVisit 10, week 52: very poor
OROS Hydromorphone HCl49925112048915044161837500
Oxycodone27925093311034150101134610

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Mode and Convenience of Drug Intake.

Subjects filled out a questionnaire based on the mode and convenience of drug intake and could rate their responses as very convenient, convenient, neither convenient or inconvenient, inconvenient, and very inconvenient. (NCT00261495)
Timeframe: weeks 4, 24, and 52

,
InterventionSubjects (Number)
Very convenient, week 4Convenient, week 4Neither convenient or inconvenient, week 4Inconvenient, week 4Very inconvenient, week 4Very convenient, week 24Convenient, week 24Neither convenient or inconvenient, week 24Inconvenient, week 24Very inconvenient, week 24Very convenient, week 52Convenient, week 52Neither convenient or inconvenient, week 52Inconvenient, week 52Very inconvenient, week 52
OROS Hydromorphone HCl57973073639631872110200
Oxycodone369430615390331181115200

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Number of Drop-outs

Number of drop-outs according to reasons for drop-out and due to inefficacy at maximal dosage was assessed at weeks 24 and 52. (NCT00261495)
Timeframe: baseline to week 24 (core); week 24 to week 52 (extension)

,
InterventionSubjects (Number)
Adverse events (core)Adverse events (extension)Consent withdrawn (core)Consent withdrawn (extension)Inadequate pain relief (core)Inadequate pain relief (extension)Investigator withdrew patient (core)Investigator withdrew patient (extension)Lost to follow up (core)Lost to follow up (extension)Non compliance (core)Non compliance (extension)Other (core)Other (extension)Protocol violation (core)Protocol violation (extension)Treatment completed no follow up visit (core)Treatment completed no follow up visit (extension)Inefficacy at maximal dosage (core)
OROS Hydromorphone HCl57412022040213164602017
Oxycodone561161181200010052600012

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Number of Subjects Indicating Optimal Sleep at Week 52

Number of subjects who experienced optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 52. Optimal sleep was defined as 7-8 hours sleep per night. (NCT00261495)
Timeframe: week 52

,
InterventionSubjects (Number)
YesNo
OROS Hydromorphone HCl2728
Oxycodone1930

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Number of Subjects Indicating That They Had Optimal Sleep at Week 24

Number of subjects indicating that they had optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 24. Optimal sleep was defined as 7 to 8 hours sleep per night. (NCT00261495)
Timeframe: baseline and week 24

,
InterventionSubjects (Number)
YesNo
OROS Hydromorphone HCl83166
Oxycodone71171

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Number of Subjects With Dose Escalation

Number of subjects with dose increase in study medication. (NCT00261495)
Timeframe: week 4 and week 24

,
InterventionSubjects (Number)
YesNo
OROS Hydromorphone HCl27176
Oxycodone34148

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Number of Subjects With Dose Escalation at Week 24 (ITT Population)

The number of subjects with dose increase in study medication was assessed at week 24. (NCT00261495)
Timeframe: week 24

,
InterventionSubjects (Number)
YesNo
OROS Hydromorphone HCl14657
Oxycodone14537

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"Change From Baseline in BPI Interference Score Interfered With General Activity (BPI Item 9a) at Week 4"

"Change from baseline in interference of pain was assessed using the BPI questionnaire, specifically BPI item 9a pain interfered with general activity at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with general activity." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.6
Oxycodone-1.9

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"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 24"

"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically average pain (BPI item 5) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in average pain." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.8
Oxycodone-1.7

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"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 4"

"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically average pain (BPI item 5) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in average pain." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.9
Oxycodone-2.1

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"Change From Baseline in BPI Pain Severity Pain at Its Least (BPI Item 4) at Week 24"

"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its least (BPI item 4) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its least." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.3
Oxycodone-1.4

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"Change From Baseline in BPI Pain Severity Pain at Its Worst (BPI Item 3) at Week 4"

"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its worst (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its worst." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.8
Oxycodone-2.1

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"Change From Baseline in BPI Pain Severity Score Pain at Its Least (BPI Item 4) at Week 4"

"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its least (BPI item 4) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its least." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.3
Oxycodone-1.8

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"Change From Baseline in BPI Pain Severity Sub-score Pain at Its Worst (BPI Item 3) at Week 24 (ITT Population)"

"Change from baseline to week 24 in BPI pain severity, pain at its worst (BPI item 3) assessed using the BPI questionnaire. Score values ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its worst." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.9
Oxycodone-1.9

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"Change From Baseline in BPI Questionnaire Item 6 Pain Right Now Score at Week 24 (Intent to Treat [ITT] Population)"

"Assessment of non-inferiority of OROS hydromorphone compared with SR oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 pain right now score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-2.1
Oxycodone-2.1

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"Change From Baseline in BPI Severity Score Pain Right Now (BPI Item 6) at Week 4"

"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain right now (BPI item 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-2.2
Oxycodone-2.6

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Number of Subjects With Dose Escalation at Week 4 (ITT Population)

The number of subjects with dose increase in study medication was assessed at week 4. (NCT00261495)
Timeframe: week 4

,
InterventionSubjects (Number)
YesNo
OROS Hydromorphone HCl17579
Oxycodone16684

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Number of Participants With a Change in Pain Score

Pain score is a measure of pain intensity using the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Data is separated into two groups: those with greater than or equal to 50% change in their pain score and those with less than 50% change in their pain score. (NCT00305058)
Timeframe: Baseline to 30 minutes after medication infused

,
InterventionParticipants (Count of Participants)
less than 50% decreasegreater than or equal to 50% decrease
Hydromorphone5340
Morphine5337

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Number of Participants With Pain Relief

Pain relief here is a subjective measure indicated by the following categories: No, Slight, Moderate, and Complete. Participants were asked to pick the category that best fit their level of pain relief 30 minutes after medication was infused. (NCT00305058)
Timeframe: 30 minutes after medication infused

,
InterventionParticipants (Count of Participants)
none or slightmoderate to complete
Hydromorphone3261
Morphine3753

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Change in Pain Intensity

Pain scores are a measure of pain intensity and are measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable). Participants are asked to rate their pain using this scale at baseline before any medication is administered and again 30 minutes after medication is infused (NCT00305058)
Timeframe: Baseline to 30 minutes after medication infused

Interventionunits on a scale (Mean)
Morphine3.3
Hydromorphone3.8

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Number of Participants Satisfied With Pain Medication

"Number of participants who were satisfied with pain medication received, based on their response of good to excellent or poor to fair. Participants were asked to pick which response best fit their satisfaction with the pain medication they received 30 minutes after that medication was infused Good to Excellent or Poor to fair." (NCT00305058)
Timeframe: 30 minutes after medication infused

,
InterventionParticipants (Count of Participants)
Good to excellentPoor to fair
Hydromorphone5934
Morphine5634

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Number of Participants Requiring Naloxone

Naloxone is a reversal agent - a medication that reverses the effects of another. Hydromorphone is an opiate pain medication that acts as a depressant to the body, thereby slowing it down. A large slow down is dangerous, as it can cause the breathing rate to slow down too much and prevent enough oxygen from entering the body and reaching the brain, resulting in death. Naloxone is a medication that blocks the receptors binding opiate pain medication and reversing the body's reaction to the hydromorphone, allowing body processes to return to normal speeds, including the breathing rate. The use of naloxone in the study indicates that the participant received too much pain medication or reacted more strongly than the average person, requiring the rescue medication to reverse the negative effects. The number of participants who required naloxone is assessed. (NCT00305110)
Timeframe: immediately after infusion, up to 120 minutes post infusion

InterventionParticipants (Count of Participants)
2 mg IV Hydromorphone0

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Number of Participants Experiencing a Systolic Blood Pressure Less Than 90 mmHg

Normal systolic blood pressure is approximately 120 mmHg. A low systolic blood pressure indicates blood, and therefore oxygen, are not being distributed around the body properly. This leads to a decreased amount of oxygen for the body to use and can result in injury or death if prolonged or severe. (NCT00305110)
Timeframe: Immediately after infusion, up to 120 minutes post infusion

InterventionParticipants (Count of Participants)
2 mg IV Hydromorphone2

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Number of Participants Experiencing a Respiratory Rate Lower Than 12 Breaths Per Minute

Normal respiratory rate ranges from 12 to 20 breaths per minute. The decreased respiration results in a decreased amount of oxygen entering the body and therefore low amount of oxygen supplied to the brain. Prolonged oxygen deprivation can result in injury or death. Respiratory rates lower than 12 breaths per minute is a sign of distress. Number of participants experiencing a respiratory rate lower than 12 breaths per minute is measured. (NCT00305110)
Timeframe: immediately after infusion, up to 120 minutes post infusion

InterventionParticipants (Count of Participants)
2 mg IV Hydromorphone12

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Oxygen Desaturation Measured Over 2-hour Time Frame

blood oxygen saturation less than 95% is considered oxygen desaturation. Blood oxygen saturation is normally above 95%. Oxygen desaturation of less than 90% is dangerous because there is less oxygen throughout the body for cellular energy. Prolonged or severe blood oxygen desaturation can result in injury or death. (NCT00305110)
Timeframe: immediately after infusion, up to 120 minutes post infusion

Interventionparticipants (Number)
at least 95% oxygen saturation, all time points90-94% oxygen saturation, one or more timesbelow 90% oxygen saturation, one or more times
2 mg IV Hydromorphone68266

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Oxygen Saturation Measured Over 2-hour Time Frame

blood oxygen saturation is measured periodically from 1 minute to 120 minutes after the medication was infused (NCT00305110)
Timeframe: baseline to 120 minutes post infusion

Intervention% oxygen saturation (Median)
Baseline1 minute post infusion2 minutes post infusion3 minutes post infusion4 minutes post infusion5 minutes post infusion15 minutes post infusion30 minutes post infusion120 minutes post infusion
2 mg IV Hydromorphone999898989897979898

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Pain Intensity Assessed Over 2-hour Time Frame

"Pain intensity is measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain possible). Participants are asked to rate their pain periodically over a 2 hour time period following infusion of the medication." (NCT00305110)
Timeframe: baseline up to 120 minutes after post infusion

Interventionunits on a scale (Median)
Baseline1 minute post infusion2 minutes post infusion3 minutes post infustion4 minutes post infusion5 minutes post infusion15 minutes post infusion30 minutes post infusion120 minutes post infusion
2 mg IV Hydromorphone1043321101

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Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale

The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst). (NCT00385541)
Timeframe: 1 hour after surgery, 8 hours after surgery

InterventionUnits on a scale (Mean)
Morphine PCA2
Hydromorphone PCA2.5

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Mean Score on the Ramsey Scale of Sedation

The Ramsey scale is used as a measure of sedation from 1 (the patient in anxious and agitated) to 6 (the patient exhibits no response). (NCT00385541)
Timeframe: 1 hour after surgery, 8 hours after surgery

Interventionscore on scale (Mean)
Morphine PCA2.8
Hydromorphone PCA2.8

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Nausea Assessment by Patient

Nausea scale range: (0 = none, 10 = the worst), ordinal. (NCT00385541)
Timeframe: 1 hour after surgery, 8 hours after surgery

InterventionUnits on a scale (Mean)
Morphine PCA4.6
Hydromorphone PCA3.0

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Pain Assessment by Patient

Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal. (NCT00385541)
Timeframe: 1 hour after surgery, 8 hours after surgery

InterventionUnits on a scale (Mean)
Morphine PCA7.9
Hydromorphone PCA7.1

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The Number of Patients Who Vomited

(NCT00385541)
Timeframe: 1 hour after surgery, 8 hours after surgery

Interventionparticipants (Number)
Morphine PCA1
Hydromorphone PCA0

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Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)

"Model was built using sparse blood samples: Sampling times: immediately predose, and between 0.25-0.75, 1-3, and 4-6 hours postdose for the first 2 doses of oral hydromorphone: predose for each dose of oral hydromorphone HCl thereafter; and at the end of study.~Efficacy was based on Oral treatment only." (NCT00465647)
Timeframe: A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.

InterventionL/hour (Number)
All Patients114

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Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time

"The Visual Analog Scale (VAS), a 10-cm Color Analog Scale anchored by the descriptors of 0 = no pain and 10 = most pain, was used by children ≥ 12 years of age." (NCT00465647)
Timeframe: Immediately prior to first oral dose, up to 54 hours

Interventionunit on a scale (Mean)
PredoseDose 1 (1 hour postdose)Dose 2 (1 hour postdose)Dose 3 (1 hour postdose)Dose 4 (1 hour postdose)Dose 5 (1 hour postdose)Dose 6 (1 hour postdose)
Oral ≥ 12 Years to < 17 Years4.043.733.954.094.134.193.25

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Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]

There are 5 categories in this pediatric pain measurement: face, legs, activity, cry, and consolability. Responses in each category are scored between 0 and 2 (0 = normal, relaxed to 2 = upset, agitated), for a maximum total score of 10. The FLACC scale was used for children under the age of 3 years and older children who have limited verbal skills. (NCT00465647)
Timeframe: Immediately prior to first oral dose, up to 54 hours

,,
Interventionunits on a scale (Mean)
PredoseDose 1 (1 hour postdose)Dose 2 (1 hour postdose)Dose 3 (1 hour postdose)Dose 4 (1 hour postdose)Dose 5 (1 hour postdose)Dose 6 (1 hour postdose)
Oral ≥ 13 Months to < 5 Years2.671.070.670.930.850.091.20
Oral ≥ 28 Days to < 13 Months1.341.130.570.270.550.700.61
Oral ≥ 5 Years to < 12 Years2.712.171.200.750.401.000.75

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Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time

Faces Pain Scale-Revised (FPS-R) consists of 6 facial expressions. Each face is 25 x 35 mm with 13 mm between faces. Each subject was asked to point to the face that reflected his or her pain. The end points are 0 = no pain and 10 = very much pain. The FPS-R scale was used for children over the age of 5 up to 12 years who have appropriate verbal skills. (NCT00465647)
Timeframe: Immediately prior to first oral dose with potentially up to 54 hours duration.

,
Interventionunits on a scale (Mean)
PredoseDose 1 (1 hour postdose)Dose 2 (1 hour postdose)Dose 3 (1 hour postdose)Dose 4 (1 hour postdose)Dose 5 (1 hour postdose)Dose 6 (1 hour postdose)
Oral ≥ 13 Months to < 5 Years1.501.201.332.67000
Oral ≥ 5 Years to <12 Years2.592.250.921.541.861.640.40

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Peak Change From Baseline Opioid Agonist Effects Assessed by the Visual Analog Scale (VAS)

"The Visual Analog Scale (VAS) measures subjective ratings of opioid agonist effects. The scale on this measure ranges from 0 being Not at all to 100 being Extremely. On this scale, higher scores indicate a stronger drug effect. The outcome measure illustrates a difference from peak (120 min) to baseline measure on VAS." (NCT00499746)
Timeframe: Measure at 120 min after drug administration

Interventionunits on a scale (Mean)
Placebo 0 mg1.4
Hydromorphone 4 mg2.9
Hydromorphone 8 mg4.8
Methylphenidate 30 mg2.1
Methylphenidate 60 mg3.4
Tramadol 50 mg0.4
Tramadol 100 mg1.6
Tramadol 200 mg2.1
Tramadol 400 mg3.8

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Peak Change From Baseline Stimulant Effects Assessed by the Visual Analog Scale (VAS)

"The Visual Analog Scale (VAS) measures subjective ratings of stimulant effects. The scale on this measure ranges from 0 being Not at all to 100 being Extremely. On this scale, higher scores indicate a stronger drug effect. The outcome measure illustrates a difference from peak (120 min) to baseline measure." (NCT00499746)
Timeframe: Measure at 120 min after drug administration

Interventionunits on a scale (Mean)
Placebo 0 mg1.4
Hydromorphone 4 mg3.6
Hydromorphone 8 mg3.6
Methylphenidate 30 mg8.0
Methylphenidate 60 mg10.6
Tramadol 50 mg0.6
Tramadol 100 mg0.9
Tramadol 200 mg4.9
Tramadol 400 mg6.9

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Physiologic Effects Assessed by the Pharmacological Class Questionnaire

"During the peak (assessed at 120 min) of each drug administration, participants were asked to complete the pharmacological class questionnaire. The pharmacological class questionnaire had volunteers indicate which drug class was most similar to the drug condition they received. Ten drug classes were listed with descriptive labels and examples of each: placebo, opiates (or opioid agonist), phenothiazines, barbiturates, antidepressants, opiate antagonists, hallucinogens, benzodiazepines, stimulants, and other. Of these choices, participants chose 3: placebo, opioid agonist, and stimulant.~The outcome measure represents the percentage of participants who chose either placebo, opioid agonist, or stimulant across each drug condition." (NCT00499746)
Timeframe: Measure at 120 min after drug administration

,,,,,,,,
Interventionpercentage of drug identification (Number)
PlaceboOpioid AgonistStimulant
Hydromorphone 4 mg25750
Hydromorphone 8 mg01000
Methylphenidate 30 mg00100
Methylphenidate 60 mg00100
Placebo 0 mg10000
Tramadol 100 mg75250
Tramadol 200 mg37630
Tramadol 400 mg256312
Tramadol 50 mg10000

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Discrimination Effects Assessed by Discrete Choice

"During discrete choice, volunteers were given three choices (placebo, hydromorphone, methylphenidate) and were asked to choose which of the training drugs they thought they received. The outcome measure illustrates the percentage of participants who chose either placebo, hydromorphone, or methylphenidate during each drug condition (i.e., Placebo, Hydromorphone 8 mg, Tramadol 50 mg, etc.), ranging from 0-100.~The outcome measure represents the percentage of participants who chose either placebo, opioid agonist, or stimulant across each drug condition." (NCT00499746)
Timeframe: 1 day

,,,,,,,,
Interventionpercentage of drug identification (Number)
PlaceboHydromorphoneMethylphenidate
Hydromorphone 4 mg25750
Hydromorphone 8 mg01000
Methylphenidate 30 mg00100
Methylphenidate 60 mg00100
Placebo 0 mg10000
Tramadol 100 mg75250
Tramadol 200 mg25750
Tramadol 400 mg256312
Tramadol 50 mg10000

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Discrimination Effects Assessed by Operant Responses

Volunteers emitted operant responses on computer keys that corresponded to the training letter, on a fixed interval 1 second schedule for 8.5 minutes. The range is from 0 to 500 operant responses. (NCT00499746)
Timeframe: 1 day

,,,,,,,,
InterventionResponses (Mean)
PlaceboHydromorphoneMethylphenidate
Hydromorphone 4 mg116.6341.30.0
Hydromorphone 8 mg0.0453.40.0
Methylphenidate 30 mg0.00.0465.4
Methylphenidate 60 mg0.00.0465.8
Placebo 0 mg455.50.00.0
Tramadol 100 mg341.3118.10.0
Tramadol 200 mg86.6367.00.0
Tramadol 400 mg115.6282.959.9
Tramadol 50 mg464.10.00.0

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Physiological Effects Assessed by Peak Change From Baseline Pupil Diameter

Change in pupil diameter (mm) at peak (120 min) compared to baseline measure of pupil diameter (NCT00499746)
Timeframe: Measure at 120 min after drug administration

Interventionmm (Mean)
Placebo 0 mg-0.5
Hydromorphone 4 mg-1.2
Hydromorphone 8 mg-1.9
Methylphenidate 30 mg-0.6
Methylphenidate 60 mg-0.3
Tramadol 50 mg-0.5
Tramadol 100 mg-0.2
Tramadol 200 mg-0.8
Tramadol 400 mg-0.8

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Acquisition of Discrimination Assessed by Accuracy of the Discrimination Test

The acquisition of discrimination was to test whether volunteers could identify each training drug condition by the correct letter code. Results are the percentage of correct responses with a range of 0% to 100%. (NCT00499746)
Timeframe: 1 day

Interventionpercent of correct response (Mean)
Placebo 0 mg87
Hydromorphone 8 mg87.5
Methylphenidate 60 mg90

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Discrimination Effects Assessed by Point Distribution

In point distribution, volunteers distributed 50 points among three training drug letters depending on how certain they were of the identity of the administrated drug. Maximum total is 50 points. (NCT00499746)
Timeframe: 1day

,,,,,,,,
InterventionPoints distributed (Mean)
PlaceboHydromorphoneMethylphenidate
Hydromorphone 4 mg11.938.10.0
Hydromorphone 8 mg0.050.00.0
Methylphenidate 30 mg0.00.050.0
Methylphenidate 60 mg0.00.050.0
Placebo 0 mg50.00.00.0
Tramadol 100 mg37.512.50.0
Tramadol 200 mg9.438.30.0
Tramadol 400 mg12.531.36.3
Tramadol 50 mg50.00.00.0

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Change From Baseline to Week 12 in Mean Pain Intensity

Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated. (NCT00549042)
Timeframe: Baseline, Week 12 (or final visit)

Interventionscore on a scale (Mean)
OROS Hydromorphone0.6
Placebo1.7

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Change in Numerical Rating Scale (NRS) Scores Among Patients Who Received 1 Dose of Intravenous (IV) Hydromorphone

"Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 (no pain) to 10 (worst pain imaginable). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department)." (NCT00627367)
Timeframe: 60 minutes

Interventionunits on a scale (Median)
Protocolized6.1
Nonprotocolized4.5

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Change in Numerical Rating Scale (NRS) Scores Among Patients in the Protocolized Group vs Those in the Physician Driven Group Who Received Only Intravenous (IV) Morphine

"Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 (no pain) to 10 (worst pain imaginable). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department). The comparison of hydromorphone to morphine is due to the wide use of morphine for pain management in the Emergency Department setting and the comparison of the two opioids in previous studies." (NCT00627367)
Timeframe: 60 minutes

Interventionunits on a scale (Mean)
Protocolized5.6
Nonprotocolized4.4

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Patient Reported Change in Pain Intensity From Initial Administration of Analgesics (Baseline) to 60 Minutes Post-baseline.

"Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 (no pain) to 10 (worst pain imaginable). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline NRS score (before treatment in the Emergency Department)." (NCT00627367)
Timeframe: 60 minutes

Interventionunits on a scale (Mean)
Protocolized5.5
Nonprotocolized4.5

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Change in Numerical Rating Scale (NRS) Scores Among Patients Who Received 2 Doses of Intravenous (IV) Hydromorphone

"Pain intensity is rated on the numerical rating scale (NRS), measured in integer units from 0 (no pain) to 10 (worst pain imaginable). The change in pain intensity subtracts the NRS score given by the patient 60 minutes after treatment was administered from the baseline score (before treatment in the Emergency Department)." (NCT00627367)
Timeframe: 60 minutes

Interventionunits on a scale (Mean)
Protocolized4.0
Nonprotocolized4.3

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Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase

Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated. (NCT00631319)
Timeframe: Baseline, Week 12

Interventionunits on a scale (Mean)
OROS Hydromorphone0.6
Placebo0.6

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Number of Patients With Reduction in Pain Intensity

Pain intensity is measured on the numerical rating scale (NRS), with a pain score from 0 (no pain) to 10 (worst pain imaginable). The reduction in pain intensity is defined here as a change in pain score by 2 or more units. (NCT00682435)
Timeframe: 60 minutes after medication infused

Intervention% of participants (Number)
Hydromorphone86

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Number of Patients Who Had Adequate Analgesia

Adequate analgesia is defined as declining additional hydromorphone within 1 hour of entering the protocol (NCT00682435)
Timeframe: 60 minutes after medication infused

InterventionParticipants (Count of Participants)
15 minutes after 1st 1mg dose of IV hydromorphone7236642315 minutes after 2nd 1 mg dose of IV hydromorphone72366423
wanted more pain medicationDid not want more pain medication
Hydromorphone51
Hydromorphone172
Hydromorphone9
Hydromorphone35

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Number of Patients With Oxygen Desaturation Less Than 95%

primary safety outcome, defined as number of participants who experienced oxygen saturation < 95% (NCT00682435)
Timeframe: 120 minutes after medication infused

InterventionParticipants (Count of Participants)
1 mg IV hydromorphone2 mg IV hydromorphone
Hydromorphone110

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Change in Pain Intensity

Pain intensity is measured on the numerical rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable) from baseline to 60 minutes after medication infused (NCT00682435)
Timeframe: 60 minutes after medication infused

Interventionunits on a scale (Median)
Hydromorphone6

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Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain

"The Investigator evaluated sleep disturbance through the participant's answers to below question in yes or no response: 'Did you wake up because of unbearable pain this morning?'" (NCT00766831)
Timeframe: Baseline and Day 15

InterventionParticipants (Number)
Baseline: YesBaseline: NoDay 15: YesDay 15: No
Hydromorphone OROS32501567

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Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score

The CGI-Improvement score evaluates how much the participant's condition is improved compared to Baseline. The score ranges from 1 to 7, where 1=improved very much, 2=Improved much, 3=Improved a little, 4=No change, 5=Aggravated a little,6=Aggravated much and 7=aggravated very much. (NCT00766831)
Timeframe: Day 15

InterventionParticipants (Number)
Improved very muchImproved muchImproved a littleNo changeAggravated a littleAggravated much
Hydromorphone OROS121372021

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Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug

Participant's preferences between the oral long-action opioids analgesic and the study drug was reported. (NCT00766831)
Timeframe: Day 15

InterventionPercentage of participants (Number)
Hydromorphone hydrochloride OROS tabletsPreviously administered strong opioid analgesic
Hydromorphone OROS80.519.5

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Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain

Percentage of treatment response in sleep disturbance caused by cancer pain was reported. Treatment response in sleep disturbance was measured by Numeric Rating Scale (NRS) ranging from 0=no disturbance to 10=extreme disturbance. (NCT00766831)
Timeframe: Day 15 or Early withdrawal

InterventionPercentage of treatment response (Number)
Hydromorphone OROS34.9

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Korean Brief Pain Inventory (K-BPI) Questionnaire Score

K-BPI is a questionnaire designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of 9 items out of which 6 items were assessed. Score of each item ranges from 0 to 10, where 0=no pain/impact and 10=severe pain/impact. The 6 items that were assessed are: a) level of pain worst in last 24 hours; b) level of pain weakest in last 24 hours; c) level of pain average in last 24 hours; d) level of pain right now; e) how much pain reduced with the therapy taken; sixth item was further classified into 7 categories: i) general activities ii) mood iii) ambulatory ability iv) routine works v) interpersonal relation vi) sleep vii) life enjoyment. (NCT00766831)
Timeframe: Baseline and Day 15

InterventionUnits on a scale (Mean)
Baseline: Worst pain in last 24 hours (n=74)Baseline: Weakest pain in last 24 hours (n=74)Baseline: Average pain in last 24 hours (n=74)Baseline: Level of pain right now (n=76)Baseline: Pain reduced from therapy taken (n=76)Baseline: General activities (n=76)Baseline: Mood (n=76)Baseline: Ambulatory ability (n=75)Baseline: Routine works (n=76)Baseline: Interpersonal relation (n=76)Baseline: Sleep (n=76)Baseline: Life enjoyment (n=76)Day 15: Worst pain in last 24 hours (n=75)Day 15: Weakest pain in last 24 hours (n=75)Day 15: Average pain in last 24 hours (n=74)Day 15: Level of pain right now (n=75)Day 15: Pain reduced from therapy taken (n=75)Day 15: General activities (n=75)Day 15: Mood (n=75)Day 15: Ambulatory ability (n=75)Day 15: Routine works (n=75)Day 15: Interpersonal relation (n=76)Day 15: Sleep (n=74)Day 15: Life enjoyment (n=75)
Hydromorphone OROS6.73.65.24.40.45.05.15.05.64.85.95.55.42.94.13.70.55.04.64.54.94.64.25.0

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Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators

Investigator evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective. (NCT00766831)
Timeframe: Day 15

InterventionParticipants (Number)
Not effectiveAverageEffectiveVery effectiveExtremely effective
Hydromorphone OROS73232101

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Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants

Participants evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective. (NCT00766831)
Timeframe: Day 15

InterventionParticipants (Number)
Not effectiveAverageEffectiveVery effective
Hydromorphone OROS729388

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Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score

The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. ECOG performance status score ranges from Grade 0 to 4, where Grade 0=Fully active, Grade 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, Grade 2=ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3=capable of only limited self-care, confined to bed or chair, and Grade 4=completely disabled. (NCT00766831)
Timeframe: Baseline and Day 15

InterventionParticipants (Number)
Baseline: Grade 0Baseline: Grade 1Baseline: Grade 2Baseline: Grade 3Baseline: Grade 4Day 15: Grade 1Day 15: Grade 2Day 15: Grade 3Day 15: Grade 4
Hydromorphone OROS1532341522253

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Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain

The participants recorded the frequency of short acting opioid analgesic taken for treating breakthrough pain among the pains suffered by the participants. Here frequency means number of times the short-acting opioid analgesic administered for breakthrough pain from baseline to Day 15 (NCT00766831)
Timeframe: Baseline and Day 15

InterventionFrequency of breakthrough pain drug (Mean)
BaselineDay 15
Hydromorphone OROS0.920.36

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Participant's Pain Intensity

Participant's pain intensity was measured using NRS ranging from 0=no pain to 10=unimaginable extreme pain. Participants maintained pain diary for 3 days before Baseline until Day 15 and pain intensity was measured twice daily (morning and afternoon). Here average pain intensity is reported. Average pain intensity was calculated as mean of morning pain intensity and evening pain intensity for each baseline and Day 15. (NCT00766831)
Timeframe: Baseline and Day 15

InterventionUnits on a scale (Mean)
BaselineDay 15
Hydromorphone OROS5.34.1

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Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug

"Participants reasons for preference between the long acting oral opioid analgesic and the study drug administered were reported. Reasonos for preferences were I experienced a certain pain relief effect during the administration of the drug, I didn't wake up due to pain while sleeping, It was more convenient because the number of administrations was reduced, I could reduce the administration of short acting narcotic analgesic to treat breakthrough pain and other." (NCT00766831)
Timeframe: Day 15

InterventionPercentage of participants (Number)
Hydromorphone OROS: pain reliefPreviously administered analgesic: pain reliefHydromorphone OROS: couldn't wake upPreviously administered analgesic:couldnHydromorphone OROS: reduced dosesPreviously administered analgesic: reduced dosesHydromorphone OROS: could reduce administrationPreviously taken analgesic: reduce administration
Hydromorphone OROS1.537.531.850.054.612.512.10

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Sleep Disturbance Questionnaire: Analgesic Administration

"The Investigator evaluated sleep disturbance through the participant's answers to below question in yes or no response: 'Did you need to take an analgesic for pain relief in order to go to sleep last night?'" (NCT00766831)
Timeframe: Baseline and Day 15

InterventionParticipants (Number)
Baseline : YesBaseline: NoDay 15: YesDay 15: No
Hydromorphone OROS37452557

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Sleep Disturbance Questionnaire: Frequency of Waking Up

The Investigator evaluated sleep disturbance through the participant's answers to below question: How many times did you wake up while sleeping late night (frequency [once, 2 times, 3 times, 4 times, 5 times, couldn't fall asleep at all] of waking up due to pain last night). (NCT00766831)
Timeframe: Baseline and Day 15

InterventionParticipants (Number)
Baseline: once (n=77)Baseline: 2 times (n=77)Baseline: 3 times (n=77)Baseline: 4 times (n=77)Baseline: 5 times (n=77)Day 15: once (n=58)Day 15: 2 times (n=58)Day 15: 3 times (n=58)Day 15: 4 times (n=58)Day 15: 5 times (n=58)
Hydromorphone OROS829216132317774

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Percentage of Patients With Successful Treatment

Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes (NCT00825370)
Timeframe: 60 minutes

InterventionPercentage of Participants (Number)
Protocolized86.8
Discretionary Care76.6

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Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes

"Patients who did not want pain medication determined by those who answered no to the question do you want more pain medication? at 60 minutes after treatment." (NCT00825370)
Timeframe: 60 minutes

Interventionpercentage of participants (Number)
Protocolized72.5
Discretionary Care63.7

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Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes

"As defined by the percentage of patients who answer no to the question, Do you want more pain medication? at 15 minutes" (NCT00825370)
Timeframe: 15 min

InterventionPercentage of Participants (Number)
Protocolized73.7
Discretionary Care66.7

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Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).

"Mean change in pain intensity between baseline and 15 minutes and between baseline and 60 minutes post treatment. Pain intensity is measured on a numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). The averages were calculated by finding the mean of change in pain intensity for each patient." (NCT00825370)
Timeframe: Up to 60 minutes

,
Interventionunits on a scale (Mean)
15 minutes60 minutes
Discretionary Care4.554.66
Protocolized4.905.32

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High VAS - Emax (mm)

"The High Visual Analog Scale (VAS) consisted of a horizontal line with a statement presented above the bar (I am feeling high). The ends of the line were marked with the descriptive anchors (Definitely not and Definitely so). Using a laptop computer, participants were instructed to click and drag the mouse to the appropriate position along the line, according to how they felt at that moment. Each scale was scored as an integer from 0 (Definitely not) to 100 (Definitely so), representing the position on the line." (NCT00955110)
Timeframe: High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose.

Interventionmm (Mean)
Placebo23.1
Oxymorphone ER 15 mg30.6
Oxymorphone ER 30 mg62.5
Oxycodone CR 30 mg81.4
Oxycodone CR 60 mg93.0

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The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event

The number of patients dropping out of the study owing to adverse events will be presented for each treatment group. (NCT00980798)
Timeframe: At each study visit from baseline until week 16

Interventionparticipants (Number)
Placebo7
OROS Hydromorphone HCl36

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Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average)

"The analgesic effect was assessed by the BPI item 5 pain on average using a 0 to 10 numeric rating scale, with 0 being no pain and 10 being pain as bad as you can imagine." (NCT00980798)
Timeframe: At each study visit from screening to week 16

,
Interventionunits on a scale (Mean)
ScreeningBaseline (Visit 1)Visit 2Visit 3Visit 4Visit 5Visit 6Visit 7Visit 8Visit 9
OROS Hydromorphone HCl6.46.65.04.64.03.93.53.44.14.4
Placebo6.46.55.24.84.33.93.73.64.04.2

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Pain Intensity Score

Average Pain intensity score experienced by Participant over the last 24 hours of Day 3 and Day 13 was recorded. Pain intensity was measured using numerical rating scale (NRS) ranging from 0=no pain to 10=most severe pain. (NCT01006356)
Timeframe: Day 3 and Day 13

InterventionUnits on a scale (Mean)
Day 3 (8 AM) (n=106)Day 3 (8 PM) (n=106)Day 13 (8 AM) (n=103)Day 13 (8 PM) (n=103)
Hydromorphone HCl OROS3.73.63.33.3

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Frequency of Experiencing Breakthrough Pain

Frequency of experiencing 3 types of breakthrough pain: Idiopathic pain (pain of unknown cause), incidental pain (pain that arises as a result of activity, such as movement of an arthritic joint, stretching a wound) and end-of-dose failure pain was reported. (NCT01006356)
Timeframe: Day 1 and Day 15

InterventionPain episodes per day (Mean)
Day 1: Incidental PainDay 15: Incidental PainDay 1: Idiopathic PainDay 15: Idiopathic PainDay 1: End-of-dose failureDay 15: End-of-dose failure
Hydromorphone HCl OROS1.10.81.81.21.00.6

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European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) which are based on 4-point scale (1=Not at all to 4=Very much); and global health status and quality of life scale based on 7-point scale (1=very poor to 7=Excellent). All scales and items are averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptomatology or problems. (NCT01006356)
Timeframe: Day 1 and Day 15

InterventionUnits on a Scale (Mean)
Day 1: Trouble in strenuous activities (n=106)Day 15: Trouble in strenuous activities (n=106)Day 1: Trouble in long walk (n=106)Day 15: Trouble in long walk (n=106)Day 1: Trouble in short walk outside house (n=106)Day 15: Trouble in short walk outside house(n=106)Day 1: Stay in bed/chair (n=106)Day 15: Stay in bed/chair (n=106)Day 1: Need help in usual activities (n=106)Day 15: Need help in usual activities (n=106)Day 1: Limitation in work/other activites (n=106)Day 15: Limitation in work/other activites (n=106)Day 1:Limitation-hobbies/leisure activites(n=106)Day 15:Limitation-hobbies/leisure activites(n=106)Day 1: Short of breath (n=106)Day 15: Short of breath (n=106)Day 1: Had pain (n=106)Day 15: Had pain (n=106)Day 1: Needs rest (n=105)Day 15: Needs rest (n=105)Day 1: Trouble in sleeping (n=106)Day 15: Trouble in sleeping (n=106)Day 1: Felt weak (n=106)Day 15: Felt weak (n=106)Day 1: Apetite loss (n=106)Day 15: Apetite loss (n=106)Day 1: Felt nauseated (n=106)Day 15: Felt nauseated (n=106)Day 1: Vomitting (n=106)Day 15: Vomitting (n=106)Day 1: Constipation (n=106)Day 15: Constipation (n=106)Day 1: Diarrhea (n=106)Day 15: Diarrhea (n=106)Day 1: Tired (n=106)Day 15: Tired (n=106)Day 1:Pain interference - daily activities(n=106)Day 15:Pain interference - daily activities(n=106)Day 1: Difficulty in concentrating (n=106)Day 15: Difficulty in concentrating (n=106)Day 1: Felt tensed (n=106)Day 15: Felt tensed (n=106)Day 1: Worried (n=106)Day 15: Worried (n=106)Day 1: Felt irritated (n=106)Day 15: Felt irritated (n=106)Day 1: Felt depressed (n=106)Day 15: Felt depressed (n=106)Day 1: Difficulty in remembering (n=104)Day 15: Difficulty in remembering (n=104)Day 1: Interference in family life (n=106)Day 15: Interference in family life (n=106)Day 1: Interference in social life (n=106)Day 15: Interference in social life (n=106)Day 1: Economical difficulties (n=106)Day 15: Economical difficulties (n=106)Day 1: Global health status (n=106)Day 15: Global health status (n=106)Day 1: Quality of life (n=106)Day 15: Quality of life (n=106)
Hydromorphone HCl OROS3.003.072.983.181.982.222.642.711.561.722.582.662.562.612.022.042.902.662.742.782.182.132.502.522.272.411.751.851.291.242.152.081.341.182.622.512.692.602.102.131.952.012.122.162.222.202.071.942.021.952.472.592.582.602.582.513.423.423.473.44

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Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15

K-BPI is an inventory designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of total 9 items in total, and the ninth item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0 to 10, where 0=no pain, 1 to 4=mild pain, 5 to 6=moderate pain and 7 to 10=severe pain. (NCT01006356)
Timeframe: Baseline and Day 15

InterventionUnits on a scale (Mean)
BaselineChange at Day 15
Hydromorphone HCl OROS3.660.359

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Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain

Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started). (NCT01006356)
Timeframe: Day 15

InterventionPercentage of Participants (Number)
Hydromorphone HCl OROS50.9

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Global Assessment of Overall Efficacy of Study Drug by Investigator

Investigator evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'. (NCT01006356)
Timeframe: Day 15

InterventionParticipants (Number)
Ineffective responseAverage responseEffective responseVery effective responseHighly effective response
Hydromorphone HCl OROS43748123

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Global Assessment of Overall Efficacy of Study Drug by Participant

Participants evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', 'effective response', 'very effectiveresponse', and 'highly effective response'. (NCT01006356)
Timeframe: Day 15

InterventionParticipants (Number)
IneffectiveAverageEffectiveVery effectiveHighly effective
Hydromorphone HCl OROS93149123

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Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score

Investigators evaluated the overall improvement of the participant's condition using CGI scale. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=greatly improved; 2=somewhat improved; 3=slightly improved; 4=no change; 5=slightly aggravated ; 6=somewhat aggravated; 7=greatly aggarvated. (NCT01006356)
Timeframe: Day 15

InterventionParticipants (Number)
greatly improvedsomewhat improvedslightly improvedno changeslightly aggravatedsomewhat aggravated
Hydromorphone HCl OROS323453012

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Participant's Preferences Along With Reasons

The number of participants who preferred oral long-acting narcotic analgesics or previously administered oral opioid analgesic were reported along with detailed and specific reasons such as consistent analgesic effect during administration, sleep undisturbed by pain, reduced intake of medication frequency, reduce intake of immediate-release opioid analgesic for breakthrough pain treatment, other and no response, for their preferences. Same participant may have multiple reason for their preference. (NCT01006356)
Timeframe: Day 15

InterventionParticipants (Number)
Hydromorphone OROS:Consistent effect(n=91)Oral Opioid: Consistent effect(n=9)Hydromorphone OROS: Sleep undisturbed(n=91)Hydromorphone OROS:reduced intake frequency(n=91)Hydromorphone OROS:reduced intake(n=91)Hydromorphone OROS:Other(n=91)Oral Opioid: Other(n=9)Oral Opioid: No response(n=9)
Hydromorphone HCl OROS33137429281

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Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in worst pain in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine. (NCT01205126)
Timeframe: Baseline and Day 29

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 29
Hydromorphone Hydrochloride (HCl)6.7-1.8
Oxycodone HCl Controlled Release (CR)6.9-1.8

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Breakthrough Pain Medication (Rescue Medication) Doses Taken

Any breakthrough pain medication taken during the overall study was reported. Morphine hydrochloride was used as a rescue medication in case of breakthrough pain. (NCT01205126)
Timeframe: Baseline up to Day 29

InterventionDoses (Mean)
Hydromorphone Hydrochloride (HCl)24.2
Oxycodone HCl Controlled Release (CR)29.3

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Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in average pain in the past 24 hours, in BPI score was reported. The score ranges from 0 to 10 wherein, 0 indicates no pain and 10 indicates pain as bad as participants could imagine. (NCT01205126)
Timeframe: Baseline and Day 29

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 29
Hydromorphone Hydrochloride (HCl)4.7-1.8
Oxycodone HCl Controlled Release (CR)4.7-1.4

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Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in pain at its least, in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine. (NCT01205126)
Timeframe: Baseline and Day 29

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 29
Hydromorphone Hydrochloride (HCl)2.4-0.8
Oxycodone HCl Controlled Release (CR)2.3-0.5

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Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. BPI comprises of total 9 items in total, and the 8th item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0% to 100%, wherein 0% indicates no relief and 100% indicates complete relief. (NCT01205126)
Timeframe: Baseline and Day 29

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 29
Hydromorphone Hydrochloride (HCl)48.815.8
Oxycodone HCl Controlled Release (CR)48.014.1

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Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in Pain Right now in BPI was reported. The score ranges from 0=no pain to 10=pain as bad as participants could imagine. (NCT01205126)
Timeframe: Baseline and Day 29

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 29
Hydromorphone Hydrochloride (HCl)4.1-1.4
Oxycodone HCl Controlled Release (CR)4.1-1.4

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Global Assessment of Treatment Satisfaction

"Patients were asked to rate their global assessment of treatment satisfaction, ranging from very dissatisfied to very satisfied. Adverse events were monitored throughout the study" (NCT01207596)
Timeframe: Baseline visit to Week 12 or last visit

Interventionpercentage of patients (Number)
Very satisfiedSatisfiedDissatisfiedVery dissatisfied
Hydromorphone38.542.315.43.8

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Sleep Quality Assessment (SQA)

Sleep Quality Assessment (SQA) scale, asking patients to assess the degree that pain has interfered with their sleep in the last 24 hours (where 0 = does not interfere and 10 = completely interferes) (NCT01207596)
Timeframe: Baseline visit to Week 12 or last visit

Interventionunits on a scale (Mean)
Hydromorphone-1.7

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Pain Quality Assessment Scale (PQAS)

The PQAS is a 20-item scale that quantifies the quality and intensity of neuropathic and non-neuropathic pain; scores range from 1 to 200, with higher scores indicating more severe pain (NCT01207596)
Timeframe: Baseline visit to 12 weeks visit

Interventionunits on a scale (Mean)
Hydromorphone-24.8

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Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #6: the Number That Tells How Much Pain You Have Right Now

"Change from baseline to end of study on question #4 (current pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that tells how much pain you have right now, where 0 = no pain and 10 = pain as bad as you can imagine." (NCT01207596)
Timeframe: Baseline visit to Week 12 or last visit

Interventionunits on a scale (Mean)
Hydromorphone-1.3

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Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #4: the Number That Best Describes Your Pain at Its Least in the Last 24 Hours

"Change from baseline to end of study on question #4 (least pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that best describes your pain at its least in the last 24 hours, where 0 = no pain and 10 = pain as bad as you can imagine." (NCT01207596)
Timeframe: Baseline visit to Week 12 or last visit

Interventionunits on a scale (Mean)
Hydromorphone-0.9

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Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #3: the Number That Best Describes Your Pain at Its Worst in the Last 24 Hours

"Change from baseline to end of study on question #3 (worst pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours, where 0 = no pain and 10 = pain as bad as you can imagine." (NCT01207596)
Timeframe: Baseline visit to Week 12 or last visit

Interventionunits on a scale (Mean)
Hydromorphone-1.8

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Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale

"The primary efficacy measure was the change from baseline to end of study on question #5 (average pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that best describes your pain on the average, where 0 = no pain and 10 = pain as bad as you can imagine." (NCT01207596)
Timeframe: Baseline visit to Week 12 or last visit

Interventionunits on a scale (Mean)
Hydromorphone-1.2

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Slope Change From Baseline for Pupil Size

Photographs of subjects' pupils were measured horizontally and vertically, 15 minutes before the first hydromorphone dose and every 15 minutes after each hydromorphone/placebo for hydromorphone dose, for up to 1 hour. Size was the product of vertical and horizontal measures. The slope, determined by linear regression, was used as a summary measure of the dose-response relationship between the hydromorphone dose and pupil size. The steeper the slope, the greater the hydromorphone effect. A slope of zero indicated no evidence of a hydromorphone effect. (NCT01218984)
Timeframe: 4 weeks (Baseline to Day 28)

Interventioncm(2)/hr (Mean)
Medisorb Naltrexone 75 mg-0.5540
Medisorb Naltrexone 150 mg-0.3607
Medisorb Naltrexone 300 mg-0.1410

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Number of Patients With Satisfactory Pain Management at 60 Minutes

The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes. (NCT01311895)
Timeframe: 60 minutes

InterventionParticipants (Count of Participants)
H2O (2 mg IV Hydromorphone)112
1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)113

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Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes

(NCT01311895)
Timeframe: 60 minutes

InterventionParticipants (Count of Participants)
H2O (2 mg IV Hydromorphone)112
1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)112

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Mean Change in Pain Intensity From Baseline to 60 Minutes

"Pain intensity is measured in numerical rating scale (NRS) units from 0 (no pain) to 10 (worst pain imaginable). The change here represents the NRS score given by the patients at 60 minutes subtracted from the score at baseline, before treatment in the Emergency Department." (NCT01311895)
Timeframe: 60 minutes

Interventionunits on a scale (Mean)
H2O (2 mg IV Hydromorphone)6.1
1+1 (1 mg IV Hydromorphone + Optional 1 mg IV Hydromorphone)5.7

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Number of Patients Who Achieved Satisfactory Analgesia at 15 Minutes Post-baseline

"Satisfactory Analgesia is defined as declining additional pain medication when asked the question, Do you want more pain medication?" (NCT01429285)
Timeframe: 15 minutes

InterventionParticipants (Count of Participants)
Hydromorphone89
Usual Care111

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Number of Patients Who Achieved Satisfactory Analgesia at 60 Minutes Post-baseline

"Satisfactory analgesia is defined as the patient declining additional pain medication when asked the question, Do you want more pain medication?. This measure refers only to the answer to this question asked at the 60 minute mark. The Primary Outcome (1. Primary Outcome - Number of Patients with successful treatment) refers to the answering no to this question at 15 minutes or 60 minutes post-baseline." (NCT01429285)
Timeframe: 60 minutes

InterventionParticipants (Count of Participants)
Hydromorphone111
Usual Care119

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Mean Change in Pain Intensity From Baseline to 60 Minutes

"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable). The change in scores over time is calculated by subtracting the score at 60 minutes from the score at baseline (before treatment). These change values were then averaged." (NCT01429285)
Timeframe: 60 minutes

Interventionunits on a scale (Mean)
Hydromorphone5.4
Usual Care5.2

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Number of Patients With 50% or Greater Decline in Pain Intensity Score From Baseline to 60 Minutes

"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable). The 50% or greater change in pain score is measured by subtracting the pain score at 60 minutes from the pain score at baseline, then dividing that value by the original baseline value and multiplying by 100% to get a percent change value." (NCT01429285)
Timeframe: 60 minutes

InterventionParticipants (Count of Participants)
Hydromorphone106
Usual Care107

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Pain Intensity Score at 60 Minutes

"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable)." (NCT01429285)
Timeframe: 60 minutes

Interventionunits on a scale (Median)
Hydromorphone3
Usual Care3

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Number of Patients With a Pain Intensity Score of 3 or Less at 60 Minutes

"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable)." (NCT01429285)
Timeframe: 60 minutes

InterventionParticipants (Count of Participants)
Hydromorphone83
Usual Care87

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Mean Change in Pain Intensity Score From Baseline to 30 Minutes

"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable). The change in NRS score is calculated by subtracting the score at 30 minutes post treatment from the score at baseline, before treatment. The average of these values was calculated." (NCT01429298)
Timeframe: 30 minutes

Interventionunits on a scale (Mean)
Hydromorphone6.7
Usual Care5.6

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Number of Participants Who Achieved at Least 50% Decline in NRS Pain Score at 30 Minutes

(NCT01429298)
Timeframe: 30 minutes

InterventionParticipants (Count of Participants)
Hydromorphone136
Usual Care111

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Number of Participants Who Declined Additional Medication at 30 Minutes

"Amount of patients who choose to forgo additional pain medication at 30 minutes post-baseline when asked the question, Do you want more pain medication?" (NCT01429298)
Timeframe: 30 minutes

InterventionParticipants (Count of Participants)
Hydromorphone127
Usual Care106

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Number of Participants Who Reported no Pain or Mild Pain at 30 Minutes

(NCT01429298)
Timeframe: 30 minutes

InterventionParticipants (Count of Participants)
Hydromorphone122
Usual Care95

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Number of Patients Who Achieved Absolute Pain Intensity Score of 3 or Less at 30 Minutes

"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable)" (NCT01429298)
Timeframe: 30 minutes

InterventionParticipants (Count of Participants)
Hydromorphone114
Usual Care90

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Change in NRS After Treadmill Walk

Numeric Rating Scale (NRS) pain score was given verbally after completing functional treadmill walk test on a scale 0-10 (0=none, and 10=the worst). (NCT01455519)
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

InterventionNRS pain score (Mean)
Sugar Pill0.1
Hydromorphone ER-0.51

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Change in Treadmill Distance Walked

Treadmill distance walked in 6 minutes (NCT01455519)
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

Interventionmiles (Mean)
Sugar Pill0.02
Hydromorphone ER0.02

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Change in Pain Disability

The Pain Disability Index (PDI) is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability. (NCT01455519)
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

Interventionunits on a scale (Mean)
Sugar Pill-9.84
Hydromorphone ER-9.25

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Change in Sit to Stand Repetitions

Sit to stand repetitions completed in 1 minute (NCT01455519)
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

Interventionnumber of repetitions (Mean)
Sugar Pill-1.07
Hydromorphone ER.54

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Change in Stair Climb Time

Time to climb 1 flight of stairs (NCT01455519)
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

Interventionseconds (Mean)
Sugar Pill1.28
Hydromorphone ER-1.25

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Change in Time to Lift Box

Time to lift 13 pound box to floor and back up to table. (NCT01455519)
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

Interventionseconds per lift (Mean)
Sugar Pill-1.45
Hydromorphone ER-1.06

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Change in VAS

Visual Analogue Scale is a self report pain scale on a scale 0(no pain) to 100 (the worst pain imaginable). (NCT01455519)
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

Interventionunits on a scale (Mean)
Sugar Pill-10.57
Hydromorphone ER-10.67

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Change in NRS After Stair Climb

Numeric Rating Scale (NRS) pain score was given verbally after completing functional stair climb test on a scale 0-10 (0=none, and 10=the worst). (NCT01455519)
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

InterventionNRS pain score (Mean)
Sugar Pill0.04
Hydromorphone ER-0.11

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Change in Distance to Floor

Distance from fingers to Floor when bending forward. A functional test of flexibility (NCT01455519)
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

Interventioncentimeters (Mean)
Sugar Pill-4.61
Hydromorphone ER-4.02

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Change in McGill Pain Questionnaire - Short Form

The McGill Pain Questionnaire - Short Form (MPQ-SF) is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain). (NCT01455519)
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

Interventionunits on a scale (Mean)
Sugar Pill-0.73
Hydromorphone ER-3.78

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Change in PASS

Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety. (NCT01455519)
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

Interventionunits on a scale (Mean)
Sugar Pill-7.14
Hydromorphone ER-5.85

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Change in NRS After Box Lift

Numeric Rating Scale (NRS) pain score was given verbally after completing functional box lift test on a scale 0-10 (0=none, and 10=the worst). (NCT01455519)
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

InterventionNRS pain score (Mean)
Sugar Pill0.39
Hydromorphone ER-0.43

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Change in NRS After Sit to Stand Repetitions

Numeric Rating Scale (NRS) pain score was given verbally after completing functional sit to stand test on a scale 0-10 (0=none, and 10=the worst). (NCT01455519)
Timeframe: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention

InterventionNRS pain score (Mean)
Sugar Pill-0.24
Hydromorphone ER-0.57

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Worst Postoperative Pain Score

"Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for worst, average, and least pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average worst postoperative pain score for each treatment arm is reported." (NCT01591382)
Timeframe: Participants were followed for the duration of hospital stay, an average of approximately 3 days.

Interventionunits on a scale (Mean)
Ketamine8.7
Placebo9.0

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Average Postoperative Pain Score

"Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for worst, average, and least pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average postoperative pain score for each treatment arm is reported." (NCT01591382)
Timeframe: Participants were followed for the duration of hospital stay, an average of approximately 3 days.

Interventionunits on a scale (Mean)
Ketamine6.0
Placebo7.3

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24-Hour Postoperative Opioid Use

Opioid use is defined as the total milligrams of hydromorphone plus other home or oral opioid used per 24 hours, converted to oral morphine equivalents. (NCT01591382)
Timeframe: For 24 hours following surgery

Interventionoral morphine mg equivalents (Mean)
Ketamine726
Placebo770

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Least Postoperative Pain Score

"Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for worst, average, and least pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average least postoperative pain score for each treatment arm is reported." (NCT01591382)
Timeframe: Participants were followed for the duration of hospital stay, an average of approximately 3 days.

Interventionunits on a scale (Mean)
Ketamine4.4
Placebo5.6

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Pain Score, Visual Analogue Pain Scores

Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). (NCT01598506)
Timeframe: 30 minutes after intrathecal injection

Interventionunits on a scale (Mean)
Hydromorphone1.9

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Pain Scores, Visual Analogue Pain Scale

Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). (NCT01598506)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Hydromorphone8.6

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Pain Scores, Visual Analogue Pain Scale

Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). (NCT01598545)
Timeframe: 24 hours after intrathecal injection

Interventionunits on a scale (Mean)
Hydromorphone3.3

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Pain Scores, Visual Analogue Pain Scale

Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). (NCT01598545)
Timeframe: 6 hours after intrathecal injection

Interventionunits on a scale (Mean)
Hydromorphone4.4

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Pain Scores, Visual Analogue Pain Scale

Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). (NCT01598545)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Hydromorphone0.45

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Pain Scores, Visual Analogue Pain Scale

Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). (NCT01598545)
Timeframe: 12 hours after intrathecal injection

Interventionunits on a scale (Mean)
Hydromorphone2.75

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Pain Scores, Visual Analogue Pain Scale

Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain). (NCT01598545)
Timeframe: 18 hours after intrathecal injection

Interventionunits on a scale (Mean)
Hydromorphone3.05

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Brief Pain Inventory (BPI) Average Score at Baseline

The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely. (NCT01648699)
Timeframe: Baseline

,,,,,,
InterventionUnits on a scale (Mean)
Severity item: Worst pain in last 24 hoursSeverity item: Least pain in last 24 hoursSeverity item: Average painSeverity item: Pain right nowInterference item: General activityInterference item: MoodInterference item: Walking abilityInterference item: Normal workInterference item: Relationships with other peopleInterference item: SleepInterference item: Enjoyment of life
OROS Hydromorphone 12 mg6.501.002.502.004.503.004.175.832.332.333.17
OROS Hydromorphone 16 mg4.001.003.002.674.335.335.336.333.332.675.00
OROS Hydromorphone 20 mg10.003.005.507.006.506.008.009.006.508.007.50
OROS Hydromorphone 24 mg2.000.001.004.000.005.003.000.008.000.007.00
OROS Hydromorphone 32 mg8.03.05.03.08.07.007.009.009.005.008.00
OROS Hydromorphone 36 mg5.03.53.55.07.06.006.509.004.504.504.00
OROS Hydromorphone 8 Milligram (mg)7.402.605.504.606.207.007.405.003.006.805.40

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Number of Participants Given Rescue Pain Medications

Rescue medication was a medication intended to relieve symptoms immediately. Rescue medication of morphine was used during the study duration and dose was set at 10-15 percent of the total daily morphine dose which ranged from 10-60 milligram. (NCT01648699)
Timeframe: Day 28

InterventionParticipants (Number)
OROS Hydromorphone 8 Milligram (mg)1
OROS Hydromorphone 12 mg4
OROS Hydromorphone 16 mg0
OROS Hydromorphone 20 mg1
OROS Hydromorphone 24 mg1
OROS Hydromorphone 32 mg2
OROS Hydromorphone 40 mg1
OROS Hydromorphone (No Dose Indicated)2

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Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician

"The Clinical Global Impression (CGI) rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant, which ranges from very much worse to very much improved (as compared to Baseline)." (NCT01648699)
Timeframe: Day 28

InterventionParticipants (Number)
Very much improved: Day 28 (n=15)Much improved: Day 28 (n=15)Minimally improved: Day 28 (n=15)No change: Day 28 (n=15)Minimally worse: Day 28 (n=15)Very much worse: Day 28 (n=15)Not evaluated: Day 28 (n=15)
OROS Hydromorphone7331001

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Brief Pain Inventory (BPI) Average Score at Day 28

The BPI assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely. (NCT01648699)
Timeframe: Day 28

,,,,,,
InterventionUnits on a scale (Mean)
Severity item: Worst pain in last 24 hoursSeverity item: Least pain in last 24 hoursSeverity item: Average painSeverity item: Pain right nowInterference item: General activityInterference item: MoodInterference item: Talking abilityInterference item: Normal workInterference item: Relationships with other peopleInterference item: SleepInterference item: Enjoyment of life
OROS Hydromorphone 12 mg3.202.402.401.004.201.804.003.201.802.601.20
OROS Hydromorphone 16 mg0.000.000.000.000.000.000.000.000.000.000.00
OROS Hydromorphone 20 mg4.001.501.500.005.005.005.005.005.002.004.00
OROS Hydromorphone 24 mg4.000.000.000.000.000.000.000.000.000.000.00
OROS Hydromorphone 32 mg7.003.675.336.677.334.678.008.005.007.335.33
OROS Hydromorphone 40 mg7.003.004.003.007.007.007.007.005.005.005.00
OROS Hydromorphone 8 Milligram (mg)2.000.002.002.002.002.000.002.001.001.001.00

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Correlation Between Change in Pain Intensity and TBW at 15 Minutes Post-treatment

Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 15 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient. (NCT01675778)
Timeframe: 15 minutes post-treatment

Interventioncorrelation coefficient (Number)
Hydromorphone-0.06

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Number of Participants Who Desired for More Analgesics

Some participants liked to receive additional analgesics after hydromorphone treatment. Number of participants who desired for additional analgesics is reported. (NCT01675778)
Timeframe: 30 minutes post-treatment

InterventionParticipants (Count of Participants)
Hydromorphone37

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Correlation Between Change in Pain Intensity and TBW at 30 Minutes Post-treatment

Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient. (NCT01675778)
Timeframe: 30 minutes post-treatment

Interventioncorrelation coefficient (Number)
Hydromorphone-0.03

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Effects of Race/Ethnicity on the Correlation Between TBW and Change in Pain Intensity

This study evaluated the effect of race/ethnicity on the correlation between total body weight (TBW) and change in pain intensity. Participants were asked to rate their pain levels from o (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient. (NCT01675778)
Timeframe: 30 minutes post-treatment

Interventioncorrelation coefficient (Number)
HispanicAfrican American
Hydromorphone-0.030.08

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Number of Participants With Oxygen Saturation Level < 92%

Opioids can induce respiratory depression, which could lead to low oxygen saturation level. Prolonged low oxygen saturation level < 92% could cause brain damage. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use. (NCT01675778)
Timeframe: 30 minutes post-treatment

InterventionParticipants (Count of Participants)
Hydromorphone1

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Effects of Single-nucleotide Polymorphisms of Opioid Metabolism (UGT2B7, -G840A) on the Correlation Between TBW and Change in Pain Intensity

This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity. Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid metabolism (UGT2B7, -G840A). Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test. (NCT01675778)
Timeframe: 30 minutes post-treatment

Interventionscore on a scale (Median)
AAAGGG
Hydromorphone5.05.06.0

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Effects of Single-nucleotide Polymorphisms of Opioid Receptor (OPRM1, A118G) on the Correlation Between TBW and Change in Pain Intensity

This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity. Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid receptor (OPRM1, A118G). Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. The median and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test. (NCT01675778)
Timeframe: 30 minutes post-treatment

Interventionscore on a scale (Median)
AAAGGG
Hydromorphone5.07.06.0

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Number of Participant With Systolic Blood Pressure < 90 mmHg

Opioids can induce low blood pressure. Prolonged low systolic blood pressure < 90 mmHg can cause shock and multi-organ failure. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use. (NCT01675778)
Timeframe: 30 minutes post-treatment

InterventionParticipants (Count of Participants)
Hydromorphone0

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Effects of Single-nucleotide Polymorphisms of Pain Sensitivity (COMT, G1947A) on the Correlation Between TBW and Change in Pain Intensity

This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity. Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving pain sensitivity (COMT, G1947A). Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test. (NCT01675778)
Timeframe: 30 minutes post-treatment

Interventionscore on a scale (Median)
AAAGGG
Hydromorphone5.06.05.0

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Pain Treatment Satisfaction Levels as Assessed by Self-report

"Participant's satisfaction with their treatment were assessed by self-report. After treatment, participants were asked How satisfied are you with the result of your pain treatment today? and they were told to pick their satisfaction level from very dissatisfied, dissatisfied, uncertain, satisfied, and very satisfied. Participants at each level is reported." (NCT01675778)
Timeframe: 30 minutes post-treatment

InterventionParticipants (Count of Participants)
Very dissatisfiedDissatisfiedUncertainSatisfiedVery satisfiedMissing
Hydromorphone282668572

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Effect of Gender on the Correlation Between BMI and Change in Pain Intensity

This study evaluated the effect of gender on the correlation between body mass index (BMI) and change in pain intensity. Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI). The reported value represents the correlation coefficient. (NCT01675778)
Timeframe: 30 minutes post-treatment

Interventioncorrelation coefficient (Number)
FemaleMale
Hydromorphone0.00170.1887

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Number of Participants With Vomit

Opioids can induce vomit. Number of participants with vomit is reported. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use. (NCT01675778)
Timeframe: 30 minutes post-treatment

InterventionParticipants (Count of Participants)
Hydromorphone4

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Number of Participants With Skin Itching

Opioids can induce skin itching. Number of participants with skin itching is reported. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use. (NCT01675778)
Timeframe: 30 minutes post-treatment

InterventionParticipants (Count of Participants)
Hydromorphone15

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Effects of Single-nucleotide Polymorphisms of Opioid Transporter (ABCB1, C3435T) on the Correlation Between TBW and Change in Pain Intensity

This study evaluated the effect of genetic factors on the correlation between Total Body Weight (TBW) and change in pain intensity. Clinical responses to hydromorphone could be affected by the single-nucleotide polymorphisms (SNPs) in gene involving opioid transporter (ABCB1, C3435T). Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. The mean and inter-quantile ranges of pain intensity reduction post-treatment were compared among patients by Kruskal-Wallis test. (NCT01675778)
Timeframe: 30 minutes post-treatment

Interventionscore on a scale (Median)
CCCTTT
Hydromorphone5.05.06.0

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Association Between Change in Pain Intensity and BMI at 15 Minutes Post-treatment

Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 15 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI). The reported value represents the correlation coefficient. (NCT01675778)
Timeframe: 15 minutes post-treatment

Interventioncorrelation coefficient (Number)
Hydromorphone-0.05

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Number of Participants With Nausea

Opioids can could induce nausea. Number of participants with nausea is reported. Understanding all potential negative impacts of Hydromorphone helps make it safer for clinical use. (NCT01675778)
Timeframe: 30 minutes post-treatment

InterventionParticipants (Count of Participants)
Hydromorphone33

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Correlation Between Change in Pain Intensity and BMI at 30 Minutes Post-treatment

Participants were asked to rate their pain levels from 0 (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported 30 minutes after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and body mass index (BMI). The reported value represents the correlation coefficient. (NCT01675778)
Timeframe: 30 minutes post-treatment

Interventioncorrelation coefficient (Number)
Hydromorphone-0.04

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Effect of Gender on the Correlation Between TBW and Change in Pain Intensity

This study evaluated the effect of gender on the correlation between Total Body Weight (TBW) and change in pain intensity. Participants were asked to rate their pain levels from o (=no pain) to 10 (= worst pain). The change in pain intensity was determined by subtracting the intensity reported before treatment from the intensity reported after treatment. Pearson correlation was used to assess the correlation between change in pain intensity and total body weight (TBW). The reported value represents the correlation coefficient. (NCT01675778)
Timeframe: 30 minutes post-treatment

Interventioncorrelation coefficient (Number)
FemaleMale
Hydromorphone0.060.11

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Effects of Age on the Correlation Between TBW and Change in Pain Intensity

Age might affect the responses to the hydromorphone treatment. The effects of age on the correlation between total body weight (TBW) and change in pain intensity. The mean of age was compared in TBW tertile groups. (NCT01675778)
Timeframe: 30 minutes post-treatment

Interventionyears (Mean)
low TBW tertilemedium TBW tertilehigh TBW tertile
Hydromorphone39.542.139.3

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Patient Global Impression of Change (PGIC)

The PGIC rating represents observed changes (if any) from the subject's Baseline Visit in activity limitations, symptoms, emotions, and overall quality of life, related to the subject's painful condition. Change is rated on a 7-point Likert-type scale from 1 (no change) through 7 (a great deal better). High score is better outcome. (NCT01709721)
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119 / Treatment Failure]

Interventionscore on a scale (Mean)
Hydromorphone Hydrochloride (Randomized/Double-Blind)4.95
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)3.73

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Proportion of Subjects Who Are Treatment Failures During the Double-blind Randomized Withdrawal Period

"Treatment failure during the Randomized Phase is defined as at least one of the following: a) increase of >= 20mm VASPI vs. baseline over 5 days; b) intolerable pain that in investigator's opinion requires intervention; or c) pain-related interventions that violate protocol from Day 84 to Day 119.~Note: Baseline pain for the randomized phase is defined as the average of the last 5 days with daily pain measurements while on an optimal intrathecal dose of Hydromorphone, between Days 77 and 83 of the open label dosing period.~Note: A subject who does not have sufficient data for evaluation, drops out for any other reasons that are not listed above or who experiences withdrawal syndrome as identified by COWS > 12 during the randomized phase will not be classified as a treatment failure.~Note: Analysis period is from beginning of randomization phase (Day 84) to end of study." (NCT01709721)
Timeframe: 5 weeks [Baseline (Day 84) to Day 119 Visit]

InterventionParticipants (Count of Participants)
Hydromorphone Hydrochloride (Randomized/Double-Blind)18
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)24

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Short-Form McGill Pain Questionnaire (SF-MPQ): Summary Score

The SF-MPQ consists of a 15 item pain rating index. The severity of each item will be scored as None (0), Mild (1), Moderate (2), or Severe (3). The total SF-MPQ score is the sum of the severity scores for each item. The total score can range from 0 to 45; high score is worse. (NCT01709721)
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]

Interventionscore on a scale, summed across 15 quest (Mean)
Hydromorphone Hydrochloride (Randomized/Double-Blind)11.05
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)16.95

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Time to Rescue - Rescue Medication Given

Number of subjects with rescue medication given (NCT01709721)
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]

InterventionParticipants (Count of Participants)
Hydromorphone Hydrochloride (Randomized/Double-Blind)16
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)27

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Time to Rescue Medication After Randomization (Days)

The number of days to rescue will be calculated by calculating the number of hours between the time of randomization and the time of rescue. The number of hours will then be divided by 24 to obtain the number of days. (NCT01709721)
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]

Interventiondays (Mean)
Hydromorphone Hydrochloride (Randomized/Double-Blind)28.85
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)24.35

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Brief Pain Inventory (BPI): Pain Severity Summary Measure

Pain severity will be evaluated by rating pain on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) for the 'worst', 'least', and 'average' pain experienced in the past 24 hours, as well as, the pain experienced 'now'. In addition, a calculated mean pain severity score will be based on the sum of all 4 of the pain scores divided by 4. If any of the 4 questions are missing, then the calculated mean pain severity score will be considered missing. High values indicate worse outcome. (NCT01709721)
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]

Interventionscore on scale (Mean)
Hydromorphone Hydrochloride (Randomized/Double-Blind)4.19
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)5.24

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"Brief Pain Inventory (BPI): Pain Severity Average"

'Average' pain experienced in the past 24 hours. The Brief Pain Inventory (BPI): Scale: 0 = No Pain, 10 = Pain as bad as you can imagine; a high score indicates a worse outcome. (NCT01709721)
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]

Interventionscore on a scale (Mean)
Hydromorphone Hydrochloride (Randomized/Double-Blind)4.09
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)4.78

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"Brief Pain Inventory (BPI): Pain Severity, Worst"

'Worst' pain experienced in the past 24 hours. Brief Pain Inventory (BPI): Scale: 0 = No Pain, 10 = Pain as bad as you can imagine; a high score indicates a worse outcome. (NCT01709721)
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119 Visit]

Interventionscore on a scale (Mean)
Hydromorphone Hydrochloride (Randomized/Double-Blind)5.62
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)6.62

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Brief Pain Inventory: Interference With Function Summary Measure

Pain interference with daily functioning will be evaluated by rating interference on a scale from 0 (does not interfere) to 10 (completely interferes) for 'general activity', 'mood', 'walking ability', 'normal work', 'relation with other people', 'sleep', and 'enjoyment of life'. A calculated mean pain interference will be based on the sum of non-missing interference questions answered divided by the number of questions answered. The mean should be set to missing if fewer than 4 pain interference questions are answered. A high score is worse. (NCT01709721)
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]

Interventionscore on scale (Mean)
Hydromorphone Hydrochloride (Randomized/Double-Blind)3.76
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)5.54

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Oral Opioid Supplement Consumption

Total consumption (mg) = The total number of milligrams consumed of any oral opioid product from Day 84 (Baseline) through the end of study will be calculated for each subject. (NCT01709721)
Timeframe: 5 Weeks [Baseline (Day 84) to Day 119]

Interventionmilligrams (mg) (Mean)
Hydromorphone Hydrochloride (Randomized/Double-Blind)6916.88
Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind)1732.84

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Patient Global Impression of Change (PGIC)

Change from Baseline in the Patient Global Impression of Change (PGIC). Scale: 7-point Likert scale, from 1 = No Change through 7 = A great deal better; a high score indicates a better outcome. Therefore, a positive change from baseline indicates a better outcome. (NCT01709747)
Timeframe: Early Termination/Final Visit through 12 months

Interventionunits on a scale (Mean)
Hydromorphone Hydrochloride0.44

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Brief Pain Inventory (BPI) - Mean Pain Severity

Change from Baseline in the Brief Pain Inventory (BPI). Pain Severity Measures, Scale: 0 = No Pain, 10 = Pain as bad as you can imagine; a high score indicates a worse outcome. Therefore, a negative change from baseline indicates a better outcome. Outcome is Mean Pain Severity score calculated as the arithmetic mean of the Worst, Least, Average and Now scores. A negative change indicates better outcome. (NCT01709747)
Timeframe: Early Termination/Final Visit through 12 months

Interventionunits on a scale (Mean)
Hydromorphone Hydrochloride-.20

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Visual Analog Scale Pain Intensity (VASPI)

Change from Baseline in Visual Analog Scale Pain Intensity (VASPI). Scale: 0 mm = No Pain, 100 mm = Unbearable Pain; high score is worse. Therefore, a negative change from baseline indicates a better outcome. (NCT01709747)
Timeframe: Early Termination/Final Visit through 12 months

Interventionmm (Mean)
Hydromorphone Hydrochloride-0.41

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Number of Participants With Total Pain Relief Score (TOTPAR4) at Four Hours After Treatment Initiation.

Primary outcome is total pain relief score (TOTPAR4) at 4 hours after treatment initiation. TOTPAR4 defined as the sum of hourly pain relief scores after baseline to four hours after the first administered dose of Lazanda or placebo. Scores range from -1 (worse pain) to 4 (complete relief). Range of possible TOTPAR4 summed scores is -4 to 16. A TOTPAR4 score greater than or equal to 8 is considered a positive response. (NCT01812759)
Timeframe: 4 hours

InterventionParticipants (Count of Participants)
Placebo1
Intervention1
No Medication0

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"Number of Patients Responding to the Question, Do You Want More Pain Medication? at Each Time Point"

"Time points 2, 3, and 4 are dependent on patient response to Do you want more pain medication? Time 1 is 30 min post-baseline. For those who answer no at Time 1, Time 2 is 30 minutes later (at 1 hour), and for those who answer yes, Time 2 is 30 minutes after additional pain medication is given. This pattern follows for Time 3 and 4, with a total study time of 4 hours" (NCT01892709)
Timeframe: 4 hours

InterventionParticipants (Count of Participants)
Time 172437239Time 272437239Time 372437239Time 472437239
YesNo
Hydromorphone42
Hydromorphone165
Hydromorphone41
Hydromorphone166
Hydromorphone31
Hydromorphone176
Hydromorphone39
Hydromorphone168

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Number of Participants Requesting Pain Medication in Different Patterns Over Time

"This is a descriptive hypothesis-generating trial, which is why it is not being compared in a randomized fashion to a comparison group. We are examining extended titration by expanding our 1+1 protocol to a 1+1+1+1 protocol and the various patterns of opioid request. For example, some may state no every time they are asked Do you want more pain medication? Some will state yes each time, and others will answer yes and no at different time periods. We will report these various patterns (i.e. X participants answered no everytime they were asked, Y answered yes everytime they were asked, Z answered no twice, etc).~Time points 2, 3, and 4 are dependent on patient response to Do you want more pain medication? Time 1 is 30 min post-baseline. For those who answer no, Time 2 is 30 minutes later (at 1 hour), and for yes, Time 2 is 30 minutes after additional pain medication is given. This pattern follows for Time 3 and 4, with a total study time of 4 hours" (NCT01892709)
Timeframe: 4 hours

InterventionParticipants (Count of Participants)
No requests for additional pain medicationRequested additional pain medication, Time 1 onlyRequested additional pain medication, Time 2 onlyRequested additional pain medication, Time 3 onlyRequested additional pain medication, Time 4 onlyRequested add'l pain medication at >1 time point
Hydromorphone94202219182

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Adverse Events and Side Effects by Total Amount of Hydromorphone Received

(NCT01892709)
Timeframe: 120 min

,,,
InterventionParticipants (Count of Participants)
Oxygen saturation <95%Respiratory Rate <10 breaths/minPulse rate <50 beats/minSystolic blood pressure <90 mmHgPruritusNauseaVomiting
1 mg Hydromorphone3111864
2 mg Hydromorphone50108145
3 mg Hydromorphone1100220
4 mg Hydromorphone0000230

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"Mean Pain Intensity Score in Numerical Rating Scale (NRS) Units at Each Time Point, Based on Response to the Question, Do You Want More Pain Medication?"

"Pain intensity is measured on the numerical rating scale (NRS) with scores from 0 (no pain) to 10 (worst pain imaginable).~Time points 2, 3, and 4 are dependent on patient response to Do you want more pain medication? Time 1 is 30 min post-baseline. For those who answer no at Time 1, Time 2 is 30 minutes later (at 1 hour), and for those who answer yes, Time 2 is 30 minutes after additional pain medication is given. This pattern follows for Time 3 and 4, with a total study time of 4 hours" (NCT01892709)
Timeframe: 4 hours

Interventionunits on a scale (Mean)
Time 1, YesTime 1, NoTime 2, YesTime 2, NoTime 3, YesTime 3, NoTime 4, YesTime 4, No
Hydromorphone7.43.87.22.97.13.16.82.4

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Number of Patients With Hypothermia (Body Temperature < 95F/35C)

intrathecally administered opioids can cause hypothermia (body temperature <95F/35C) (NCT01943565)
Timeframe: 24hrs post administration of IT hydromorphone

InterventionParticipants (Count of Participants)
Hydromorphone 25mcg0
Hydromorphone 50mcg0
Hydromorphone 100mcg0

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Intraoperative Vasopressor Use: Phenylephrine Equivalents

"IT (intrathecal ) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely).~Total intraoperative vasopressor use will be reported for phenylephrine equivalents." (NCT01943565)
Timeframe: Intraoperatively (at time of operation)

Interventionmcg (Mean)
Hydromorphone 25mcg751.04
Hydromorphone 50mcg695.54
Hydromorphone 100mcg560.11

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Intraoperative Vasopressor Use: Ephedrine Equivalents

IT (intrathecal) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely). Total intraoperative vasopressor use will be reported for ephedrine equivalents. (NCT01943565)
Timeframe: Intraoperatively (at time of operation)

Interventionmg (Mean)
Hydromorphone 25mcg60.98
Hydromorphone 50mcg56.48
Hydromorphone 100mcg45.48

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24hr Post-partum IV Opioid Requirement

Intrathecal (IT) hydromorphone added to intrathecally administered local anesthetics for spinal anesthesia increases patient comfort by decreasing post-operative pain. This leads to a decrease in the post-operative intravenous hydromorphone requirements. (NCT01943565)
Timeframe: 24hrs after administration of intrathecal hydromorphone

Interventionmg (Mean)
Hydromorphone 25mcg3.44
Hydromorphone 50mcg3.11
Hydromorphone 100mcg4.40

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Number of Patients With Pruritus

IT opioids can cause pruritus. Persistent pruritus requiring treatment will be recorded. (NCT01943565)
Timeframe: 24hrs post administration of IT hydromorphone

InterventionParticipants (Count of Participants)
Hydromorphone 25mcg0
Hydromorphone 50mcg4
Hydromorphone 100mcg3

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Patients With Nausea and Vomiting Requiring Rescue Medication

IV and IT opioids can induce nausea and vomiting. Outcome measure is reported as percentage of patients with nausea and vomiting requiring rescue medication. (NCT01943565)
Timeframe: 24hrs post administration of IT hydromorphone

InterventionParticipants (Count of Participants)
Hydromorphone 25mcg3
Hydromorphone 50mcg2
Hydromorphone 100mcg2

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Number of Patients With Visual Disturbances

IT/IV opioids can create visual disturbances. The number of patients with visual disturbances are reported. (NCT01943565)
Timeframe: 24hrs post administration of IT hydromorphone

InterventionParticipants (Count of Participants)
Hydromorphone 25mcg0
Hydromorphone 50mcg0
Hydromorphone 100mcg0

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Oxygen Saturation, Need for Supplemental Oxygen

Intravenously, and to a lesser extent, intrathecally administered opioids can lead to respiratory depressions. Therefore the subjects' oxygen saturation is measured (standard clinical practice). (NCT01943565)
Timeframe: 24hrs post administration of IT hydromorphone

Interventionpercentage oxygenated haemoglobin (Mean)
Hydromorphone 25mcg98.3
Hydromorphone 50mcg99.0
Hydromorphone 100mcg98.4

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Number of Participants Experiencing Delirium

(NCT01986946)
Timeframe: Post-operative Day 3

Interventionparticipants (Number)
Intravenous Opioids0
Epidural Catheter0

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Number of Participants Experiencing Delirium

(NCT01986946)
Timeframe: Post-operative Day 2

Interventionparticipants (Number)
Intravenous Opioids0
Epidural Catheter0

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Number of Participants Experiencing Delirium

(NCT01986946)
Timeframe: Post-operative Day 1

Interventionparticipants (Number)
Intravenous Opioids0
Epidural Catheter0

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Length of Hospital Stay

(NCT01986946)
Timeframe: during hospitalization (approximately 3-8 days)

Interventiondays (Mean)
Intravenous Opioids4.4
Epidural Catheter4.33

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Patient Satisfaction With Perioperative Analgesia

Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied). (NCT01986946)
Timeframe: 6-Week Follow up Visit

Interventionunits on a scale (Mean)
Intravenous Opioids2
Epidural Catheter1.5

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Patient Satisfaction With Perioperative Analgesia

Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied). (NCT01986946)
Timeframe: Post-operative Day 1

Interventionunits on a scale (Mean)
Intravenous Opioids2.4
Epidural Catheter1.29

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Total Post-operative Opioid Consumption

(NCT01986946)
Timeframe: during hospitalization (approximately 3-8 days)

Interventionoral morphine equivilant (mg) (Mean)
Intravenous Opioids438.52
Epidural Catheter410.42

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Patient Satisfaction With Overall Care

Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied). (NCT01986946)
Timeframe: 6-Week Follow up Visit

Interventionunits on a scale (Mean)
Intravenous Opioids1
Epidural Catheter1.5

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Post-operative Pain as Assessed by Visual Analogue Scale (VAS)

The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain. (NCT01986946)
Timeframe: Postoperative day 1

Interventionunits on a scale (Mean)
Intravenous Opioids36.33
Epidural Catheter40.63

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Number of Participants Readmitted to Hospital Within 30 Days of Surgery

(NCT01986946)
Timeframe: Post-operative Day 30

Interventionparticipants (Number)
Intravenous Opioids0
Epidural Catheter0

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Pruritus

Patients will be evaluated by a member of the study team at 24 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded. (NCT02009722)
Timeframe: 24 hours after spinal

Interventionparticipants (Number)
Intrathecal Hydromorphone8
Intrathecal Morphine8

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Treatment for Pruritus

The number of patients needing medical treatment for pruritus in first 24 hours after surgery (NCT02009722)
Timeframe: First 24 hours after spinal

Interventionparticipants (Number)
Intrathecal Hydromorphone8
Intrathecal Morphine4

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Side Effects: Nausea

Patients will be evaluated by a member of the study team at 6 hours after spinal administration. Patients with moderate or severe nausea will be recorded. (NCT02009722)
Timeframe: 6 hours after spinal

Interventionparticipants (Number)
Intrathecal Hydromorphone11
Intrathecal Morphine16

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Side Effects: Pruritus

Patients will be evaluated by a member of the study team at 6 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded. (NCT02009722)
Timeframe: 6 hours after spinal administration

Interventionparticipants (Number)
Intrathecal Hydromorphone23
Intrathecal Morphine19

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Side Effects: Sedation

Patients will be evaluated by a member of the study team at 6, 12, and 24 hours after spinal administration. The presence of sedation will be graded by the Richmond Agitation Sedation Scale. Patients with a score of (-)2 or lower on the Richmond were classified as being positive for sedation. (NCT02009722)
Timeframe: 6, 12, and 24 hours after spinal administration

Interventionparticipants (Number)
Intrathecal Hydromorphone0
Intrathecal Morphine0

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Treatment for Nausea

number of patients needing medication treatment for nausea in first 24 hours (NCT02009722)
Timeframe: First 24 hours

Interventionparticipants (Number)
Intrathecal Hydromorphone13
Intrathecal Morphine17

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Dose of IT Morphine and IT Hydromorphone for Adequate Analgesia (Pain Score Less Than or Equal to 3) in 90% of Patients

Each patient will be interviewed by a member of the study team 12 hours after receiving their spinal anesthetic (which will include either hydromorphone or morphine). Patients will be asked to rate their current level of pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A pain score <4 will be considered a success. The up-down sequential allocation method will be used to determine the dose (mcg) of IT hydromorphone and IT morphine for subsequent patients (NCT02009722)
Timeframe: 12 hours after administration of spinal anesthesia

Interventionmicrograms (Number)
Intrathecal Hydromorphone75
Intrathecal Morphine150

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Nausea

Patients will be evaluated by a member of the study team at 12 hours after spinal administration. The number of patients with moderate or severe nausea will be recorded. (NCT02009722)
Timeframe: 12 hours after spinal

Interventionparticipants (Number)
Intrathecal Hydromorphone7
Intrathecal Morphine5

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Nausea

Patients will be evaluated by a member of the study team at 24 hours after spinal administration. The number of patients with moderate or severe nausea will be recorded. (NCT02009722)
Timeframe: 24 hours after spinal

Interventionparticipants (Number)
Intrathecal Hydromorphone1
Intrathecal Morphine4

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Pruritus

Patients will be evaluated by a member of the study team at 12 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded. (NCT02009722)
Timeframe: 12 hours after spinal

Interventionparticipants (Number)
Intrathecal Hydromorphone10
Intrathecal Morphine9

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Reinforcing Effects (Breakpoint) by Study Week Analyzed by Mixed Model for Repeated Measures

"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Reinforcing Effects tasks began >= 5 hours after hydromorphone challenge. Participants made 12 choices between a preference for working for the amount of hydromorphone dosed that day or for money. The hydromorphone break point value is assigned to the highest level of hydromorphone units earned, with 1 unit having a breakpoint value of 5 and 12 units with a value of 2160.~A repeated measures mixed-effects analysis of variance (ANOVA) was performed with the log transformed hydromorphone break point value as the dependent variable with period, hydromorphone sequence and hydromorphone dose as fixed effects, and subject nested within hydromorphone sequence as a random effect.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,,
Interventionunits on a scale (Least Squares Mean)
Baseline Week -1Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Hydromorphone 18 mg7.0425.7085.4965.6696.0304.9365.2825.9654.7475.4374.9975.0765.615
Hydromorphone 6 mg7.1215.3794.7795.7065.5334.4704.4195.8084.4184.4324.5784.1144.623
Placebo4.9844.7674.0364.7604.1444.5644.3035.0923.8994.3424.5464.3304.029

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"Change From Placebo in VAS Score for Do You Feel Any Drug Effect? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"

"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme drug effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,
Interventionunits on a scale (Least Squares Mean)
Baseline Week -1: 0.00/0.00 %Week 1: 67.88/67.09 %Week 2: 66.06/66.49 %Week 3: 66.00/66.44 %Week 4: 65.11/65.35 %Week 5: 76.29/76.42 %Week 6: 75.70/75.69 %Week 7: 75.64/75.43 %Week 8: 74.79/75.18 %Week 9: 73.97/74.04 %Week 10: 73.08/74.18 %Week 11: 73.05/73.51 %Week 12: 71.31/71.30 %
Hydromorphone 18 mg55.645.233.694.857.761.460.691.641.944.510.061.940.98
Hydromorphone 6 mg35.773.011.011.743.981.560.20-0.09-0.97-0.22-0.160.130.24

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"Change From Placebo in VAS Score for Do You Feel Sedated? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"

"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme sedation 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,
Interventionunits on a scale (Least Squares Mean)
Baseline Week -1: 0.00/0.00 %Week 1: 67.88/67.09 %Week 2: 66.06/66.49 %Week 3: 66.00/66.44 %Week 4: 65.11/65.35 %Week 5: 76.29/76.42 %Week 6: 75.70/75.69 %Week 7: 75.64/75.43 %Week 8: 74.79/75.18 %Week 9: 73.97/74.04 %Week 10: 73.08/74.18 %Week 11: 73.05/73.51 %Week 12: 71.31/71.30 %
Hydromorphone 18 mg27.584.203.923.765.111.342.201.551.614.49-0.122.44-0.26
Hydromorphone 6 mg11.102.780.380.842.801.76-0.23-0.12-0.640.54-0.590.552.06

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Reinforcing Effects Of the Daily Randomized Hydromorphone Challenge as Measured by the Mean Hydromorphone Break Point Value at Weeks 1-12

"The ability of RBP-6000 to reduce the reinforcing effects of hydromorphone used money as a choice alternative to hydromorphone.~Reinforcing Effects Tasks began no earlier than 5 hours after randomised hydromorphone administration for each day. Each test consisted of the participant making 12 choices between a preference for working for the amount of hydromorphone dosed earlier that day or for money (each choice therefore has a scale of 0-12). The hydromorphone break point value is the ratio of the highest number of choices for hydromorphone to the highest number of choices for money. Hydromorphone breakpoint values were then analysed by week using a repeated measures mixed-effects model with period, hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect. Analyses were carried out on the log10 transformed hydromorphone breakpoint value." (NCT02044094)
Timeframe: Weeks 1 (Days 5-7), 2 (Days 12-14), 3 (Days 19-21), 4 (Days 26-28), 5 (Days 33-35), 6 (Days 40-42), 7 (Days 47-49), 8 (Days 53-56), 9 (Days 61-63), 10 (Days 68-70), 11 (Days 75-77), 12 (Days 82-84)

,,
Interventionlog10 transformed ratio (Least Squares Mean)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Hydromorphone 18 mg2.4792.3872.4622.6192.1442.2942.5912.0622.3612.1702.2052.438
Hydromorphone 6 mg2.3362.0752.4782.4031.9411.9192.5221.9191.9251.9881.7872.008
Placebo2.0701.7532.0671.8001.9821.8692.2121.6941.8861.9741.8801.750

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"Change From Placebo in VAS Score for Does the Drug Have Any Bad Effects? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"

"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme bad effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,
Interventionunits on a scale (Least Squares Mean)
Baseline Week -1: 0.00/0.00 %Week 1: 67.88/67.09 %Week 2: 66.06/66.49 %Week 3: 66.00/66.44 %Week 4: 65.11/65.35 %Week 5: 76.29/76.42 %Week 6: 75.70/75.69 %Week 7: 75.64/75.43 %Week 8: 74.79/75.18 %Week 9: 73.97/74.04 %Week 10: 73.08/74.18 %Week 11: 73.05/73.51 %Week 12: 71.31/71.30 %
Hydromorphone 18 mg6.25-0.010.530.390.43-0.100.03-0.12-0.040.06-0.100.05-0.02
Hydromorphone 6 mg2.350.040.140.08-0.030.030.03-0.090.010.02-0.080.11-0.01

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"VAS Score for Do You Feel Any Drug Effect? by Study Week Analyzed by Mixed Model for Repeated Measures"

"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme drug effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,,
Interventionunits on a scale (Least Squares Mean)
Baseline Week -1Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Hydromorphone 18 mg58.9126.4335.4666.0468.2692.3881.3642.2693.2405.0330.7092.9351.269
Hydromorphone 6 mg39.0474.2142.7872.9334.4912.4970.8720.5330.3290.3050.4911.1180.524
Placebo3.2741.2001.7751.1930.5140.9330.6730.6251.2970.5220.6540.9930.285

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"Change From Placebo in VAS Score for Does the Drug Have Any Good Effects? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"

"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme good effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,
Interventionunits on a scale (Least Squares Mean)
Baseline Week -1: 0.00/0.00 %Week 1: 67.88/67.09 %Week 2: 66.06/66.49 %Week 3: 66.00/66.44 %Week 4: 65.11/65.35 %Week 5: 76.29/76.42 %Week 6: 75.70/75.69 %Week 7: 75.64/75.43 %Week 8: 74.79/75.18 %Week 9: 73.97/74.04 %Week 10: 73.08/74.18 %Week 11: 73.05/73.51 %Week 12: 71.31/71.30 %
Hydromorphone 18 mg58.515.833.506.177.651.410.751.651.864.420.152.561.70
Hydromorphone 6 mg40.763.010.601.714.031.400.35-0.07-1.10-0.130.03-0.130.13

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"Change From Placebo in VAS Score for How High Are You Right Now? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"

"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme high from the drug 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy 6 mg / 18 mg" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,
Interventionunits on a scale (Least Squares Mean)
Baseline Week -1: 0.00/0.00 %Week 1: 67.88/67.09 %Week 2: 66.06/66.49 %Week 3: 66.00/66.44 %Week 4: 65.11/65.35 %Week 5: 76.29/76.42 %Week 6: 75.70/75.69 %Week 7: 75.64/75.43 %Week 8: 74.79/75.18 %Week 9: 73.97/74.04 %Week 10: 73.08/74.18 %Week 11: 73.05/73.51 %Week 12: 71.31/71.30 %
Hydromorphone 18 mg50.944.853.154.377.141.442.091.821.854.02-0.021.510.71
Hydromorphone 6 mg30.403.060.521.673.661.550.42-0.12-1.17-0.25-0.230.040.17

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"Opioid Blockade Following Administration of Hydromorphone Challenge As Measured Using the Subjective Opioid Effects Rating for the Question Do You Like the Drug? Visual Analog Scale (VAS) at Weeks 1-4 Analyzed by Mixed Model for Repeated Measures"

"The study's primary objective was to determine if the opioid blocking effect for the first injection of buprenorphine 300 mg (RBP-6000) on Day 1 was not inferior to placebo when challenged by hydromorphone.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme liking of the drug 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone administration on the challenge days listed in the time frame field. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis." (NCT02044094)
Timeframe: Weeks 1 (Days 5-7), 2 (Days 12-14), 3 (Days 19-21), 4 (Days 26-28)

,,
Interventionunits on a scale (Least Squares Mean)
Week 1Week 2Week 3Week 4
Hydromorphone 18 mg8.3744.7506.2467.211
Hydromorphone 6 mg5.1032.4362.1833.849
Placebo1.4471.8501.3200.534

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"VAS Score for Do You Feel Sedated? by Study Week Analyzed by Mixed Model for Repeated Measures"

"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme sedation 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,,
Interventionunits on a scale (Least Squares Mean)
Baseline Week -1Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Hydromorphone 18 mg30.9795.4017.0484.8975.7742.4453.3543.8943.3954.9961.0323.2990.086
Hydromorphone 6 mg14.5043.9793.5081.9753.4622.8730.9232.2331.1421.0410.5671.4032.408
Placebo3.3991.1993.1261.1350.6611.1101.1522.3481.7870.5061.1550.8580.344

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"VAS Score for Does the Drug Have Any Bad Effects? by Study Week Analyzed by Mixed Model for Repeated Measures"

"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme bad effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,,
Interventionunits on a scale (Least Squares Mean)
Baseline Week -1Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Hydromorphone 18 mg11.0461.1071.5071.2281.1170.6900.5250.6420.5080.4340.4030.5690.368
Hydromorphone 6 mg7.1451.1591.1200.9260.6630.8170.5210.6660.5530.3950.4200.6290.387
Placebo4.7971.1170.9800.8420.6910.7850.4940.7600.5440.3760.5040.5230.393

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"VAS Score for Does the Drug Have Any Good Effects? by Study Week Analyzed by Mixed Model for Repeated Measures"

"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme good effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,,
Interventionunits on a scale (Least Squares Mean)
Baseline Week -1Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Hydromorphone 18 mg61.6407.0725.2637.3958.1302.2701.1642.2253.1464.8150.6813.7122.251
Hydromorphone 6 mg43.8884.2522.3642.9304.5082.2640.7610.5040.1880.2700.5641.0230.681
Placebo3.1311.2391.7681.2210.4760.8630.4100.5741.2890.3990.5361.1490.550

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"VAS Score for How High Are You Right Now? by Study Week Analyzed by Mixed Model for Repeated Measures"

"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme high from the drug 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,,
Interventionunits on a scale (Least Squares Mean)
Baseline Week -1Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Hydromorphone 18 mg53.5976.2405.1735.7317.7372.3042.5552.4813.2774.5340.6242.4600.994
Hydromorphone 6 mg33.0524.4442.5393.0284.2512.4060.8780.5400.2610.2650.4170.9870.458
Placebo2.6541.3862.0201.3620.5950.8600.4630.6611.4310.5190.6440.9500.289

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"Visual Analog Scale (VAS) Score for Do You Like the Drug? by Study Week Analyzed by Mixed Model for Repeated Measures"

"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme liking of the drug 30 minutes before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11." (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,,
Interventionunits on a scale (Least Squares Mean)
Baseline Week -1Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Hydromorphone 18 mg63.5038.3744.7506.2467.2112.2583.6002.5503.2034.6160.7224.7093.756
Hydromorphone 6 mg48.2525.1032.4362.1833.8491.7850.7890.5210.2250.3280.5071.1540.939
Placebo2.8921.4471.8501.3200.5341.0480.4400.6721.2700.4510.5961.4710.973

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Change From Placebo in Reinforcing Effects (Breakpoint) by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)

"This endpoint explores the correlation between the reinforcing effects of hydromorphone and simulated mu opioid receptor occupancy.~Data are reported as change from placebo least square mean of Log10 transformed values for reinforcing effects. Reinforcing Effects tasks began >= 5 hours after hydromorphone challenge. Participants made 12 choices between a preference for working for the amount of hydromorphone dosed that day or for money. The hydromorphone break point value is assigned to the highest level of hydromorphone units earned, with 1 unit having a breakpoint value of 5 and 12 units with a value of 2160.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,
Interventionlog10 transformed ratio (Least Squares Mean)
Baseline Week -1: 0.00/0.00 %Week 1: 67.88/67.09 %Week 2: 66.06/66.49 %Week 3: 66.00/66.44 %Week 4: 65.11/65.35 %Week 5: 76.29/76.42 %Week 6: 75.70/75.69 %Week 7: 75.64/75.43 %Week 8: 74.79/75.18 %Week 9: 73.97/74.04 %Week 10: 73.08/74.18 %Week 11: 73.05/73.51 %Week 12: 71.31/71.30 %
Hydromorphone 18 mg0.890.410.630.400.820.160.430.380.370.480.200.320.69
Hydromorphone 6 mg0.930.270.320.410.60-0.040.050.310.230.040.01-0.090.26

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Participants With Treatment-Emergent Adverse Events (TEAE)

"TEAE=any untoward medical occurrence that develops or worsens in severity after administration of study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required intervention to prevent one of the outcomes listed above.~All adverse events that occurred between Day 1 to Day 91 are reported under the Depot Buprenorphine treatment arm.~Adverse events that occurred on the day of a hydromorphone challenge are also reported under the appropriate hydromorphone challenge arm." (NCT02044094)
Timeframe: Depot Buprenorphine: Day 1 to Day 91. The three hydromorphone challenge levels were randomly assigned to one day in each of the three-day groupings spanning 12 weeks: Days 5-7, 11-14, 19-21, 26-28, 33-35, 40-42, 47-49, 54-56, 61-63, 68-70, 75-77, 82-84

,,
InterventionParticipants (Count of Participants)
>=1 TEAE>=1 Severe TEAEDeaths>=1 SAE other than deathWithdrew from study due to a TEAE
Hydromorphone 18 mg Challenge250000
Hydromorphone 6 mg Challenge260000
Placebo Challenge290000

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Participants With Treatment-Emergent Adverse Events (TEAE)

"TEAE=any untoward medical occurrence that develops or worsens in severity after administration of study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required intervention to prevent one of the outcomes listed above.~All adverse events that occurred between Day 1 to Day 91 are reported under the Depot Buprenorphine treatment arm.~Adverse events that occurred on the day of a hydromorphone challenge are also reported under the appropriate hydromorphone challenge arm." (NCT02044094)
Timeframe: Depot Buprenorphine: Day 1 to Day 91. The three hydromorphone challenge levels were randomly assigned to one day in each of the three-day groupings spanning 12 weeks: Days 5-7, 11-14, 19-21, 26-28, 33-35, 40-42, 47-49, 54-56, 61-63, 68-70, 75-77, 82-84

InterventionParticipants (Count of Participants)
>=1 TEAE>=1 TEAE related to study drug>=1 Severe TEAEDeaths>=1 SAE other than deathWithdrew from study due to a TEAE
Depot Buprenorphine39250000

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Plasma Concentrations of Buprenorphine Summarized by Study Week

"PK Sampling Schedule:~Day -17 to -15: before hydromorphone admin~Day -4: before Suboxone admin~Day 2: 24 hours after RBP-6000 admin~Days 5-7, 12-14, 19-21 and 26-28: immediately before hydromorphone admin~Days 29: before RBP-6000 admin~Day 30: 24 hours after RBP-6000 admin~Days 33-35, 40-42, 47-49, 54-56, 61-63, 68-70, 75-77, and 82-84: immediately before hydromorphone admin" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,,
Interventionng/mL (Mean)
Week -1Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Hydromorphone 18 mg0.0002.0421.9701.9161.8123.6673.5213.4663.4973.2101.1501.0832.624
Hydromorphone 6 mg0.0002.1641.8741.8821.7763.6493.5303.4953.3653.1223.0392.9852.646
Placebo0.0002.0301.8921.9331.7223.6843.4233.4273.3263.1562.9853.1172.626

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"Change From Placebo in VAS Score for Do You Like the Drug? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"

"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme liking of the drug 30 minutes before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,
Interventionunits on a scale (Least Squares Mean)
Baseline Week -1: 0.00/0.00 %Week 1: 67.88/67.09 %Week 2: 66.06/66.49 %Week 3: 66.00/66.44 %Week 4: 65.11/65.35 %Week 5: 76.29/76.42 %Week 6: 75.70/75.69 %Week 7: 75.64/75.43 %Week 8: 74.79/75.18 %Week 9: 73.97/74.04 %Week 10: 73.08/74.18 %Week 11: 73.05/73.51 %Week 12: 71.31/71.30 %
Hydromorphone 18 mg60.616.932.904.936.681.213.161.881.934.170.133.242.78
Hydromorphone 6 mg45.363.660.590.863.320.740.35-0.15-1.05-0.12-0.09-0.32-0.03

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Predicted mu Opioid Receptor Occupancy (μORO) by Mean Buprenorphine Concentrations and Study Week

"A population pharmacokinetic/pharmacodynamic (PK/PD) model was developed to model the relationship between buprenorphine plasma concentrations and brain μORO based on 2 published clinical trials. This model used individual buprenorphine plasma concentrations measured to derive muORO individual predictions that were further described using summary statistics. The relationship between buprenorphine plasma concentration and μORO was best described by a maximal effect (Emax) model:~µORO = E(max)*Cp / EC(50) + Cp~Where Cp is the plasma concentration of buprenorphine, Emax is the maximal μORO, and EC50 is the plasma concentration of buprenorphine that is expected to achieve 50% of the maximal μORO. A direct (instantaneous) relationship between buprenorphine plasma concentration and µORO, i.e. without equilibration delay, was assumed.~Row title format: Study Week: buprenorphine plasma concentrations for placebo/ 6 mg / 18 mg challenge dosages" (NCT02044094)
Timeframe: Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)

,,
Interventionpercentage receptor occupancy (Mean)
Baseline Week -1: 0.00/0.00/0.00Week 1: 2.03/2.16/2.04Week 2: 1.89/1.87/1.97Week 3: 1.93/1.88/1.92Week 4: 1.72/1.78/1.81Week 5: 3.68/3.65/3.67Week 6: 3.42/3.53/3.52Week 7: 3.43/3.50/3.47Week 8: 3.33/3.37/3.50Week 9: 3.16/3.12/3.21Week 10: 2.99/3.04/3.19Week 11: 3.12/2.99/3.08Week 12: 2.63/2.65/2.62
Hydromorphone 18 mg0.00067.08966.48566.43865.34976.41775.68675.42975.17974.03674.17973.50771.303
Hydromorphone 6 mg0.00067.87566.05966.00065.10876.28575.69975.64174.79273.97073.07573.05471.313
Placebo0.00067.07766.07166.44264.27076.34675.43275.35174.54474.00073.00273.38571.274

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Verbal Pain Scale Scores During Postoperative Days 0-4

The aim of this study is to compare the efficacy of epidural and IV analgesia in controlling pain in patients undergoing Nuss repair of pectus excavatum. The primary end point will be the mean pain scores during postoperative days (POD) 0-4. Pain was measured using the verbal pain scale. The scale ranges from 0-10. A score of 0 means the patient is in no pain. (NCT02056301)
Timeframe: Postoperative days 0-4

,
Interventionunits on a scale (Mean)
Post-Operative Day 0Post-Operative Day 1Post-Operative Day 2Post-Operative Day 3Post-Operative Day 4
Epidural Catheter2.281.112.142.732.14
Patient Controlled Analgesia3.692.772.252.692.24

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Total Morphine Equivalent Consumption During Postoperative Days 0-4

This outcome measures total amount of morphine administered in mg/kg by post-operative day 0-4. This captures all standard of care opioids delivered via their assigned cohort route (Epidural vs. IV PCA). Opioids other than morphine that were administered for pain were multiplied by their equianalgesic conversion factor to calculate the IV Morphine equivalent. (NCT02056301)
Timeframe: Postoperative days 0-4

,
Interventionmg/kg (Mean)
Day 0Day 1Day 2Day 3Day 4
Epidural Catheter0.140.230.610.920.45
Patient Controlled Analgesia0.750.900.670.570.39

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Rescue Morphine Equivalent Administration During Postoperative Days 0-4

This outcome measures the amount of rescue morphine administered due to breakthrough pain in mg/kg by post-operative day 0-4. This captures additional opioids that were administered by a nurse through an IV. Opioids other than morphine that were administered for pain were multiplied by their equianalgesic conversion factor to calculate the IV Morphine equivalent. (NCT02056301)
Timeframe: Postoperative days 0-4

,
Interventionmg/kg (Mean)
Day 0Day 1Day 2Day 3Day 4
Epidural Catheter0.570.260.700.390.10
Patient Controlled Analgesia1.260.230.130.070.05

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Median Pain Score

Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain. (NCT02062879)
Timeframe: Participants will be followed for their entire hospital stay, an expected average of 1 week

Interventionscores on a scale (Median)
Ketamine6.3
Hydromorphone5.3

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Total Daily Opioid Requirement

Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents (NCT02062879)
Timeframe: Participants will be followed for their entire hospital stay, an expected average of 1 week.

Interventionmg morphine equivalents/day (Median)
Ketamine10
Hydromorphone42.5

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Breakthrough Daily Opioid Requirement

Breakthrough daily opioid requirement in milligrams of morphine equivalents/day (NCT02062879)
Timeframe: Participants will be followed for their entire hospital stay, an expected average of 1 week

Interventionmg morphine equivalents/day (Median)
Ketamine10
Hydromorphone10

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Post Operative Fentanyl PCA Consumption

Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op. (NCT02096003)
Timeframe: at 24 hours

Interventionµg (Mean)
Intrathecal Morphine300
Intrathecal Hydromorphone446

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Pain Score

Assess pain scores on a scale of 1-5, with higher score indicating more pain. (NCT02096003)
Timeframe: at 24 hours

Interventionscore on a scale (Mean)
Intrathecal Morphine4.8
Intrathecal Hydromorphone4.7

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Patient Satisfaction Score

Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction (NCT02096003)
Timeframe: at 24 hours

Interventionscore on a scale (Mean)
Intrathecal Morphine4.8
Intrathecal Hydromorphone4.6

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Symptom Scale for Two Specific Side Effects of Nausea and Pruritus

Symptom scale for nausea and pruritus. Full scale from 1-5, with higher score indicating more symptoms. (NCT02096003)
Timeframe: up to 24 hours

,
Interventionscore on a scale (Mean)
NauseaPruritus
Intrathecal Hydromorphone4.74
Intrathecal Morphine4.43.8

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Chronic Persistent Surgical Pain-Weekly Frequency of Pain

0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant (NCT02107339)
Timeframe: 12 months after surgery

Interventionscore on a scale (Median)
Methadone Group0
Hydromorphone Group2

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Pain Scores Postanesthesia Care Unit (PACU) Arrival

11-point verbal rating scale (0=no pain, 10=worst pain imaginable) (NCT02107339)
Timeframe: First 5 minutes after PACU arrival

Interventionunits on a scale (Median)
Methadone Group5
Hydromorphone Group8

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Pain Scores on Postoperative Day One

11-point verbal rating scale (0=no pain, 10=worst pain imaginable) (NCT02107339)
Timeframe: Pain scores one day after PACU admission

Interventionunits on a scale (Median)
Methadone Group4
Hydromorphone Group5

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Pain Scores on Postoperative Day 2

11-point verbal rating scale (0=no pain, 10=worst pain imaginable) (NCT02107339)
Timeframe: Pain scores 48 hours after PACU admission

Interventionunits on a scale (Median)
Methadone Group4.56
Hydromorphone Group6

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Pain Scores 2 Hours After PACU Arrival

11-point verbal rating scale (0=no pain, 10=worst pain imaginable) (NCT02107339)
Timeframe: Pain scores at 120 minutes after PACU admission

Interventionunits on a scale (Median)
Methadone Group4
Hydromorphone Group6

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Pain Scores 1 Hour After PACU Arrival

11-point verbal rating scale (0=no pain, 10=worst pain imaginable) (NCT02107339)
Timeframe: Pain scores at 60 minutes after PACU admission

Interventionunits on a scale (Median)
Methadone Group4
Hydromorphone Group6

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Hydromorphone Use Third 24 Hours

(NCT02107339)
Timeframe: 48-72 hours after surgery

Interventionmilligrams (Median)
Methadone Group0
Hydromorphone Group0.35

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Hydromorphone Use Second 24 Hours

(NCT02107339)
Timeframe: 24-48 hours after surgery

Interventionmilligrams (Median)
Methadone Group0.6
Hydromorphone Group3.15

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Hydromorphone Use at 24 Hours

(NCT02107339)
Timeframe: Use of hydromorphone at 24 hours

Interventionmilligrams (Median)
Methadone Group4.56
Hydromorphone Group9.9

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Chronic Persistent Surgical Pain-weekly Frequency of Pain

0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant (NCT02107339)
Timeframe: 3 months after surgery

Interventionscore on a scale (Median)
Methadone Group0
Hydromorphone Group3

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Chronic Persistent Surgical Pain-Weekly Frequency of Pain

0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant (NCT02107339)
Timeframe: One month after surgery

Interventionscore on a scale (Median)
Methadone Group2
Hydromorphone Group3

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Patient Satisfaction Scores

Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best)) (NCT02107339)
Timeframe: Postopertive day 1

Interventionunits on a scale (Median)
Methadone Group92.5
Hydromorphone Group80

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Chronic Persistent Surgical Pain-Weekly Frequency of Pain

0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant (NCT02107339)
Timeframe: 6 months after surgery

Interventionscore on a scale (Median)
Methadone Group0
Hydromorphone Group2

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Pain Scores Postoperative Day 3

11-point verbal rating scale (0=no pain, 10=worst pain imaginable) (NCT02107339)
Timeframe: Pain scores 72 hours after PACU admission

Interventionunits on a scale (Median)
Methadone Group4
Hydromorphone Group5

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Patient Satisfaction Scores

Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best)) (NCT02107339)
Timeframe: postoperative day 2

Interventionunits on a scale (Median)
Methadone Group90
Hydromorphone Group82.5

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Patient Satisfaction Scores

Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best)) (NCT02107339)
Timeframe: Postoperative day 3

Interventionunits on a scale (Median)
Methadone Group95
Hydromorphone Group90

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Time to First Ingestion of Solid Food

(NCT02164929)
Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

InterventionDays (Mean)
Paravertebral Block1
TAP Block2
Epidural0.75
No Block (PCA Alone)1.5

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Length of Stay

(NCT02164929)
Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

InterventionDays (Mean)
Paravertebral Block2.66
TAP Block4.33
Epidural4
No Block (PCA Alone)3.5

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Pain Scores

"Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where 0 represents no pain and 10 represents worst pain ever, at 30, 60, 90, 120 min and every 6 hours for 24 hours and every 12 hours for 48 hours and once a day thereafter until discharge. Data were collected at the indicated time points and an average pain score was calculated." (NCT02164929)
Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

InterventionUnits on a scale (Mean)
Paravertebral Block4.66
TAP Block2.66
Epidural1.75
No Block (PCA Alone)6

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Postoperative Opioid Consumption

If opioid other than fentanyl is used, the dose will be converted to morphine equivalent. (NCT02164929)
Timeframe: 24 hours after surgery

Interventionmcg (Mean)
Paravertebral Block734
TAP Block666
Epidural125
No Block (PCA Alone)1017.5

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Quality of Recovery

Quality of Recovery Score (QoR-15) is measured on a scale of 0-150 (0=poor, 150 = excellent). Scores were collected daily for 72 hours and then averaged. (NCT02164929)
Timeframe: 72 hours

InterventionUnits on a scale (Mean)
Paravertebral Block89.5
TAP Block117
Epidural115.5
No Block (PCA Alone)99

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Time to First Bowel Movement

(NCT02164929)
Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

Interventiondays (Mean)
Paravertebral Block1
TAP Block2
Epidural1
No Block (PCA Alone)2

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"Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire"

"The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: Feel Drug, Feel High, Like Drug, and Want More. The Feel Drug, Feel High, Like Drug, and Want More subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. The values shown below are only from week 4" (NCT02205983)
Timeframe: End of study (time 0 and approximately 4 weeks later), week 4 reported.

,,,
Interventionunits on a scale (Mean)
Feel DrugLike DrugFeel HighWant More
1000 mg Acetaminophen289.61157.38
2 mg Hydromophone7.4125.96.088.0
4 mg Hydromphone14.7535.5810.3326.83
Dextrose5.764.152.612.65

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Change in Pain Visual Analogue Scale (VAS) Scores Over Time

"Pain severity was assessed at arrival and every 30 minutes until discharge from the ED using a 100 mm visual analogue scale (VAS). The VAS range is 0 to 100 with 0 indicating no pain and 100 indicating pain as bad as it could be or worst imaginable pain. Discharge was defined by which one of the following occurred first: (a) decision to admit to hospital; (b) patient physically leaves the ED to home; or (c) after six hours of observation in the ED.~A hierarchical random coefficients regression model for repeated measurements (type of mixed hierarchical mixed-effect model) was conducted on the pain scores collected at six time points (arrival, post-placement 30-min, 60-min, 90-min,120-min, discharge) to evaluate the trajectory of change in pain. Discharge occurred at 120 minutes or later during each visit, with the exception of one discharge at 54 minutes." (NCT02222246)
Timeframe: Every 30 minutes from arrival in ED to discharge from the ED, up to 6 hours

,
InterventionUnits on a 100 mm VAS (Mean)
Emergency Department ArrivalPost-placement 30 minutesPost-placement 60 minutesPost-placement 90 minutesPost-placement 120 minutesEmergency Department Discharge
Patient Specific Dose of Morphine Sulfate or Hydromorphone82.279.677.274.772.240.9
Standard Dose of Morphine Sulfate or Hydromorphone82.280.679.077.475.955.7

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Difference in Pain Score as Measured by a Visual Analogue Scale (VAS)

"Each ED study visit was the unit of analysis for the statistical methods addressing the primary outcome. The primary outcome was change in pain score from arrival to discharge. Pain severity was assessed at arrival and discharge from ED using a 100 mm visual analogue scale (VAS). The VAS range is 0 to 100 with 0 indicating no pain and 100 indicating pain as bad as it could be or worst imaginable pain.Discharge was defined by which one of the following occurred first: (a) decision to admit to hospital; (b) patient physically leaves the ED to home; or (c) after six hours of observation in the ED. Thus, the difference in pain scores were calculated as the arrival minus discharge VAS scores, with higher positive pain difference or change scores indicating greater pain reduction." (NCT02222246)
Timeframe: Arrival in ED to discharge from the ED, up to 6 hours

InterventionUnits on a 100 mm VAS (Mean)
Standard Dose of Morphine Sulfate or Hydromorphone26.4
Patient Specific Dose of Morphine Sulfate or Hydromorphone43.0

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Severe Sedation

Ramsay Sedation Scale 0-6 (NCT02223377)
Timeframe: At 2hrs or at the time of discharge from PACU

InterventionParticipants (Count of Participants)
Morphine5
Hydromorphone8

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Time to Discharge From Hospital

For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours. (NCT02223377)
Timeframe: At 5 hours post-admit to hospital

InterventionHours (Mean)
Morphine3.2
Hydromorphone3.3

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Time to Discharge From PACU

For a day surgery case, from the time out of operating room to discharge from PACU is an average 2 hours. (NCT02223377)
Timeframe: At 2hrs or at the time of discharge from PACU

InterventionMinutes (Mean)
Morphine91.2
Hydromorphone92.8

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Mean Dose of Analgesic Used

For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours. (NCT02223377)
Timeframe: 5 hours post-admit to hospital

InterventionEquivalent morphine unit (Mean)
Morphine5.7
Hydromorphone4.9

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Number of Patients With Severe Itching

Severe itching measured as visual analog scale score > 5 on a 0-10 Visual Analog Scale, where 0 = no itching, and 10 = worst itching imaginable (NCT02223377)
Timeframe: At 2hrs or at the time of discharge from PACU

InterventionParticipants (Count of Participants)
Morphine2
Hydromorphone5

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Our Combined Primary Outcome Will be Number of Patients With Same Analgesia Minimal Emesis, as Compared Between the 2 Groups.

Our combined primary outcome will be number of patients with SAME, as compared between the 2 groups. Analgesia will be based on Numerical Analogue Scale for Pain 0-10 (appendix 3), and Post-operative nausea and vomiting will be based on Verbal Descriptive Scale 0-5 (appendix 3). These observations will be made at the end of 2 hrs or before (corresponding to the time of discharge from PACU), by the PACU nurse. (NCT02223377)
Timeframe: At 2hrs or at the time of discharge from PACU

InterventionParticipants (Count of Participants)
Morphine172
Hydromorphone175

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Patients Requesting Oral Analgesia in the Day Surgery Unit

Use of rescue drug for pain (NCT02223377)
Timeframe: At 2hrs or at the time of discharge from PACU

InterventionParticipants (Count of Participants)
Morphine128
Hydromorphone135

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Patient Satisfaction Score

Patient satisfaction is measured on a 0-10 visual analogue scale, where 0=completely unsatisfied; 10=extremely satisfied (NCT02223377)
Timeframe: At 5 hours post-admit to hospital

Interventionscore on a scale (Mean)
Morphine9.1
Hydromorphone9.3

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Severe Respiratory Depression

Presence of Respiratory Rate below 10 and/or Presence of Oxygen Saturation <90 (NCT02223377)
Timeframe: At 2hrs or at the time of discharge from PACU

InterventionParticipants (Count of Participants)
Morphine11
Hydromorphone10

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Number of Participants With Adverse Events (AEs)

Clinically significant changes in vital signs, pulse oximetry, and/or clinical laboratory assessments, were recorded as AEs (NCT02321319)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Hydromorphone HCl ER Tablets1

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Mean Pain Score

Postoperative mean pain score for 48 hours after surgery. Pain was assessed on a 0 to 10 point visual analog scale (VAS), with 0 indicating no pain and 10 indicating severe pain. The mean pain score was summarized as the area under the curve (AUC) of the observed pain score, normalized for the total time of observation. (NCT02356198)
Timeframe: First 48 hours post operative

Interventionscore on a scale (Mean)
TAP Block (EXPAREL)3.0
Intrathecal Opioid (IT)2.4

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Number of Participants With Post-operative Ileus

Post-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery. (NCT02356198)
Timeframe: 24 hours post-operatively

InterventionParticipants (Count of Participants)
TAP Block (EXPAREL)11
Intrathecal Opioid (IT)14

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Total Length of Hospital Stay

Length of stay was defined as the total number of nights spent in the hospital after surgery. (NCT02356198)
Timeframe: post-operative to discharge

Interventionnights (Median)
TAP Block (EXPAREL)3
Intrathecal Opioid (IT)3

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Total Morphine Milligram Equivalents Use (MME)

The total cumulative use of opioids administered within 48 hours after surgery. MME is a standard value based on morphine and its potency assigned to all opioids to represent relative potencies. (NCT02356198)
Timeframe: First 48 hours post operative

Interventiontotal morphine milligram equivalents (Median)
TAP Block (EXPAREL)47.5
Intrathecal Opioid (IT)32.5

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Use of Intravenous Patient-controlled Analgesia

The total number of patients that used patient-controlled analgesia within 48 hours after surgery. (NCT02356198)
Timeframe: First 48 hours post-operative

InterventionParticipants (Count of Participants)
TAP Block (EXPAREL)5
Intrathecal Opioid (IT)1

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Number of Participants Needing Rescue Medication as Assessed by Questionnaire

Data collected by telephone. Patients were asked if they needed additional medication after discharge in order to reduce level of pain. This additional medication is considered rescue medication. (NCT02389829)
Timeframe: 48 hours after discharge from Emergency Department

InterventionParticipants (Count of Participants)
Hydromorphone23
Prochlorperazine4

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Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire

Participants were asked to evaluate pain status since discharge. Participants who achieved total headache freedom for at least 1 hour are considered to achieve short term headache relief. (NCT02389829)
Timeframe: 48 hours after discharge from Emergency Department

InterventionParticipants (Count of Participants)
Hydromorphone16
Prochlorperazine29

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Number of Participants With Sustained Headache Relief Assessed by Self-evaluation

"Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours, without use of addition medication. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration." (NCT02389829)
Timeframe: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department

InterventionParticipants (Count of Participants)
Hydromorphone20
Prochlorperazine37

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Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire

"Participants were asked to make evaluation of pain status since discharge. Those achieving headache level mild or none for 1 hour are considered to achieve short term headache relief." (NCT02389829)
Timeframe: 48 hours after discharge from Emergency Department

InterventionParticipants (Count of Participants)
Hydromorphone33
Prochlorperazine53

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Number of Recorded Episodes of Emesis

Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. (NCT02423876)
Timeframe: Up to 5 days post-surgery

Interventionnumber of episodes (Mean)
Arm I (Epidural Placement, ERP).192
Arm II (ERP).1875

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Post-operative Antiemetic Use (Measured in mg of Ondanestron Used in the First 24 Hours After Surgery)

Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. (NCT02423876)
Timeframe: Up to 4 weeks post-surgery

Interventionmg (Mean)
Arm I (Epidural Placement, ERP)4.46
Arm II (ERP)3.17

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Post-operative Complications (UTIs, Thromboembolic Events, Pneumonia, Blood Transfusion, Myocardial Infarction, Falls)

# of events in each group will be reported (NCT02423876)
Timeframe: Up to 6 weeks post-surgery

InterventionParticipants (Count of Participants)
Arm I (Epidural Placement, ERP)15
Arm II (ERP)12

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Average Daily Pain Score as Measured by Pain NRS Scores

Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. (NCT02423876)
Timeframe: Up to 2 days following surgery

Interventionscore on a scale (Mean)
Arm I (Epidural Placement, ERP)3.98
Arm II (ERP)5.12

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Length of Time Until Return of Bowel Function

Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. (NCT02423876)
Timeframe: From completion of surgery to passage of flatus (report in days)

Interventiondays (Mean)
Arm I (Epidural Placement, ERP)2.22
Enhanced Recovery Pathway2.20

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Difference in IL-2 Levels Between Pre-operative and Post-operative Values

Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. (NCT02423876)
Timeframe: Baseline to up to day 1 post-surgery

Interventionnmol/L (Mean)
Arm I (Epidural Placement, ERP)9.6
Arm II (ERP)15.5

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Epidural Discontinuation Rates Prior to Planned Removal (in Epidural Group Only)

Will be tabulated and presented for each group (where applicable). (NCT02423876)
Timeframe: Up to post-operative day 14

InterventionParticipants (Count of Participants)
Arm I (Epidural Placement, ERP)4

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Total Opioid Use Measured in Oral Morphine Equivalents (mg)

Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. (NCT02423876)
Timeframe: Up to first 2 days post-surgery

Interventionmg (Mean)
Arm I (Epidural Placement, ERP)50.1
Arm II (ERP)82.56

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Length of Hospital Stay (Hours)

Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. (NCT02423876)
Timeframe: From admission to time of discharge order placement

Interventionhours (Mean)
Arm I (Epidural Placement, ERP)99.83
Enhanced Recovery Pathway87.25

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Relative Pain Scores, as Measured by the Pain Numeric Rating Scale (NRS)

Relative pain scores between the epidural and non-epidural group will be analyzed by calculating a two-sided 95% confidence interval on the difference in mean scores between the two groups and concluding non-inferiority if this lies entirely below 2 points (mean non-epidural pain score proven, within a 95% confidence limit, to be at most 2 points worse than mean pain score in the epidural group). NRS rates pain on a 1-10 scale, with 1 being no pain, and 10 being the worst pain imaginable. (NCT02423876)
Timeframe: Up to 24 hours post-surgery

Interventionscore on a scale (Mean)
Arm I (Epidural Placement, ERP)3.87
Arm II (ERP)4.95

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Readmission Rate

Will be compared using two-sided 95% confidence intervals for their mean differences. Superiority tests at the two-sided .05 level will be conducted by determining whether these confidence intervals overlap. (NCT02423876)
Timeframe: Up to 6 weeks post-surgery

InterventionParticipants (Count of Participants)
Arm I (Epidural Placement, ERP)2
Arm II (ERP)2

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Score on Verbal Numeric Rating Scale

Pain was measured using the Verbal Numerical Rating Scale (VNRS). The VNRS is a self-reported measure of pain that is administered verbally by asking a patient to rate their pain on a scale from 0 to 10, with 0 representing no pain, and 10 representing maximum pain. More information about the VNRS in children can be found here: https://bit.ly/2VZ7aWU (NCT02437669)
Timeframe: 1 hour

Interventionunits on a scale (Mean)
Intranasal Hydromorphone5.1

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Score on Faces Pain Scale - Revised

"Pain was measured using the Faces Pain Scale - Revised (FPS-R). The FPS-R is a self-reported measure of pain that is administered using a picture of 6 different faces lined up in a row, each face representing an escalating degree of pain intensity. The faces, starting from the left-most face and moving towards the right-most face, are scored 0, 2, 4, 6, 8 and 10. A score of 0 represents no pain, a score of 10 represents very much pain (i.e. maximum possible pain). More information about the FPS-R can be found here: https://bit.ly/2VPk8GM" (NCT02437669)
Timeframe: 1 hour

Interventionunits on a scale (Mean)
Intranasal Hydromorphone4.7

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Number of Minor Adverse Events

Lightheadedness, dizziness; confusion; sleepy, drowsy, tiredness; nausea; vomiting; itchiness, warm sensation; dry mouth; bad taste in mouth; rhinitis. (NCT02437669)
Timeframe: 6 hours

InterventionMinor adverse events (Number)
Intranasal Hydromorphone39

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Number of Major Adverse Events

Oxygen desaturation, respiratory depression, hypotension, bradycardia, need for supplemental oxygen, bag-mask ventilation, airway support intervention, administration naloxone. (NCT02437669)
Timeframe: 6 hours

InterventionMajor adverse events (Number)
Intranasal Hydromorphone0

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Non-inferiority of Fentanyl Nasal Spray Versus Intravenous Opioids in the Change in the Numeric Rating Scale (NRS) Pain Intensity Score at One Hour, Starting From the Time of Drug Delivery (Treatment Initiation).

The median change in Numeric Rating Scale (NRS) pain intensity scores (assessed on an 11-point Likert scale with 0 = no pain and 10 = worst pain) from randomization, estimate of treatment initiation, to one hour post-treatment calculated for both treatment arms. (NCT02459964)
Timeframe: Baseline, One hour post time of drug delivery/treatment initiation

InterventionNRS Pain Intensity Score (Median)
Treatment Arm 1 (Intranasal Fentanyl)5.14
Treatment Arm 2 (Intravenous Hydromorphone)4.90

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Number of Participants With Change in Numeric Rating Scale (NRS) Pain Intensity Score

Change in NRS pain intensity scores from randomization to one hour after treatment start based on the percentage of participants with severe pain, NRS score = 7-10, one hour after treatment start for both treatment arms. Numeric Rating Scale (NRS) pain intensity scores (assessed on an 11-point Likert scale with 0 = no pain and 10 = worst pain). (NCT02459964)
Timeframe: One (1) hour after treatment start.

InterventionParticipants (Count of Participants)
Treatment Arm 1 (Intranasal Fentanyl)5
Treatment Arm 2 (Intravenous Hydromorphone)10

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Post-operative Narcotic Usage

Narcotic usage was collected for first 48 hours post-operatively after breast reconstruction. The type and amount of each narcotic administered were each converted to the morphine equivalent amount that would be orally administered to achieve the same event. This term is known as the oral morphine equivalent (OME). Narcotic usage was assessed between the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the observed OME for each group. (NCT02601027)
Timeframe: 48 hours

Interventionmilligrams (mg) (Mean)
0.125% Bupivacaine139.3
Placebo169.2

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Quality of Life Measurement

Quality of life for the study groups was assessed with the BREAST-Q questionnaire, a survey set of 6 pre-operative questionnaires comprised of 58 questions, and 15 post-operative questionnaires, collected 2 to 6 months after surgery, which is comprised of 109 questions. The results range for the pre-operative and post-operative questionnaire sets is 0 to 269 and 0 to 462, respectively. Because the baseline and post-operative domains are different, the BREAST-Q survey is not a measure of quality of life change over time. The Breast Q questionnaire was validated by Pusic, et al (citation provided). Higher scores for a domain represents better quality of life. The outcome is reported as the mean for each group and timepoint, with standard deviation. (NCT02601027)
Timeframe: Pre-operative Baseline and Post-operative (2-6 months)

,
Interventionscore on a scale (Mean)
Pre-operative baselinePost-operative (2 to 6 month)
0.125% Bupivacaine97.30342.11
Placebo99.08358.00

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Time to First Bowel Movement

Time to first bowel movement is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant was to be able to pass a stool post-operatively. The outcome is reported as the time in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control. (NCT02601027)
Timeframe: up to 1 week

Interventiondays (Mean)
0.125% Bupivacaine1.67
Placebo1.62

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Time to Ambulation

Time to ambulation is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant to be able to stand up and walk a few steps post-operatively. The assessment of whether or not the participant was able to walk was subjective on the part of the shift nurse (ie, no defined number of steps nor quantitative assessment of gait or stability), and was not explicitly defined in the protocol or elsewhere. The outcome is reported as the time to ambulation in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control. (NCT02601027)
Timeframe: up to 1 week

Interventiondays (Mean)
0.125% Bupivacaine1.28
Placebo1.45

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Post-operative Pain Score

Post-operative Pain Score is defined using Visual Analog Scale (VAS), a patient-reported pain score based on viewing a graphic of a scale 0 to 10, and indicating pain level. Each participant was asked about 48 hours after breast reconstruction to indicate their their perceived pain according on the VAS scale. Higher scores represent greater pain. The outcome is reported as the mean VAS score at 48 hours, with standard deviation. (NCT02601027)
Timeframe: 2 days

Interventionunits on a scale (Mean)
0.125% Bupivacaine3.76
Placebo3.96

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Post-operative Anti-emetic Usage

Odansetron by intravenous administration was used to control nausea (ie, an anti-emetic drug). Anti-emetic usage was collected for first 48 hours post-operatively after breast reconstruction for the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the mean quantity of Odansetron in milligrams (mg) administered to each group, with standard deviation. (NCT02601027)
Timeframe: 48 hours

Interventionmilligrams (mg) (Mean)
0.125% Bupivacaine5.14
Placebo9.93

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Narcotic Use

Quantity of systemic narcotic used (hydromorphone hydrochloride, Dilaudid) averaged per day over the length of hospital stay, in mg/24 hours. (NCT02604589)
Timeframe: 3 days or hospital length of stay, if less than 3 days

Interventionmg/24 hours over days 1-3 (Mean)
PCA Only3.7
Bupivicaine 0.25% (LOW DOSE)8.2
Bupivicaine 0.5% (HIGH DOSE)2.5

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Mortality

All cause death, death associated with infusion catheter, within 30 days from date of randomization. This outcome will be scored as yes/no and cause of death will be collected. (NCT02604589)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
PCA Only0
Bupivicaine 0.25% (LOW DOSE)0
Bupivicaine 0.5% (HIGH DOSE)0

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Surgical Intensive Care Unit (SICU) Length of Stay

Integer days of admission to the surgical intensive care unit. For patients not requiring admission to surgical intensive care, patient is not analyzed. Usual range is 3-5 days. (NCT02604589)
Timeframe: from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit

Interventiondays (Mean)
PCA Only2.3
Bupivicaine 0.25% (LOW DOSE)5.1

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Time to Improvement in Pain Intensity

Determine the impact of catheter-infused medications on self-reported pain intensity reported as a change from baseline (admission) at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group) on a 0-10 point Likert scale, with 0=no pain, and 10= the worst pain ever. Response will be defined as time to a decrease of at least two points on the scale. (NCT02604589)
Timeframe: 3 days or hospital length of stay, if less than 3 days

Interventiondays (Mean)
PCA Only2.0
Bupivicaine 0.25% (LOW DOSE)3.0
Bupivicaine 0.5% (HIGH DOSE)1.0

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Time to Improvement in Pulmonary Function

Determine the impact of catheter-infused medications on maximal inspiratory lung volume measured by incentive spirometer (IS) as a change from baseline at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group). Endpoint will be the time to improvement of vital capacity to greater than 1.4 liters (or 15 mL/kg). (NCT02604589)
Timeframe: 3 days or hospital length of stay, if less than 3 days

Interventiondays (Mean)
PCA Only1.7
Bupivicaine 0.25% (LOW DOSE)1.8
Bupivicaine 0.5% (HIGH DOSE)1.0

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Morbidity

Collection of complications observed at any point during the hospital admission that included randomization, including pneumothorax, hemothorax, acute respiratory distress syndrome, pneumonia, empyema, need for tracheostomy, need for mechanical ventilation, length of time on mechanical ventilation, and an assessment of the degree of association of each event with the catheter insertion procedure or with underlying trauma. Each of these outcomes will be scored as yes/no. (NCT02604589)
Timeframe: 3 days or hospital length of stay, whichever is longer

Interventionnumber of complications (Number)
PCA Only0
Bupivicaine 0.25% (LOW DOSE)0
Bupivicaine 0.5% (HIGH DOSE)0

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Hospital Length of Stay

Integer days of inpatient admission in the hospital stay that included randomization. (NCT02604589)
Timeframe: from randomization to discharge, usually within the range of 5-15 days

Interventiondays (Mean)
PCA Only5.0
Bupivicaine 0.25% (LOW DOSE)11.1
Bupivicaine 0.5% (HIGH DOSE)3.6

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Change in Pain Intensity Over Time

"Pain intensity is measured on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable).~Change in pain intensity is calculated by subtracting pain intensity at a later time point from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(15 min)].~Change over time is from baseline to a series of time points: 5 minutes, 15 minutes, 30 minutes, and 45 minutes" (NCT02621619)
Timeframe: baseline to 5 min, 15 min, 30 min, and 45 minutes

,
Interventionunits on a scale (Mean)
Baseline to 5 minutesBaseline to 15 minutesBaseline to 30 minutesBaseline to 45 minutes
IV Acetaminophen + 0.5 mg IV Hydromorphone3.44.75.15.5
Placebo + 0.5 mg IV Hydromorphone2.94.04.85.2

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Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused

"Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable).~Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(60 min)].~Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given." (NCT02621619)
Timeframe: baseline and 60 minutes after medication was infused

Interventionunits on a scale (Mean)
IV Acetaminophen + 0.5 mg IV Hydromorphone5.8
Placebo + 0.5 mg IV Hydromorphone5.2

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The Number of Prophylactic Interventions for PONV

the absolute number of prophylactic interventions applied between the admission of the patient in the holding room until admission to the PACU. (NCT02625181)
Timeframe: A specific time frame on the day of surgery: from the start of admission at the holding room to the end of the anesthetic case

Interventionprophylactic antiemetics administered (Mean)
Baseline Measurement2.196
CDS Email Recommendations2.176
CDS Email + Real TIme Recommenations2.129

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Adherence to PONV Guidelines

PONV guideline adherence: percentage of patients who received the exact number of prophylactic interventions for PONV that were recommended by the decision support. (NCT02625181)
Timeframe: A specific time frame on the day of surgery: the start of admission at the holding room to the end of the anesthetic case

InterventionParticipants (Count of Participants)
Baseline Measurement666
CDS Email Recommendations5260
CDS Email + Real TIme Recommenations5863

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PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting

The occurrence of PONV, as defined by the administration of antiemetics in the PACU between admission to PACU and discharge from PACU. (NCT02625181)
Timeframe: PACU recovery period

InterventionParticipants (Count of Participants)
Baseline Measurement139
CDS Email Recommendations1323
CDS Email + Real TIme Recommenations1343

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Time to Discharge From the Postanesthesia Care Unit (PACU)

This is the number of minutes from admission to the PACU until discharge, assessed up to 2 days (NCT02625181)
Timeframe: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU

Interventionminutes (Mean)
Baseline Measurement266
CDS Email Recommendations264
CDS Email + Real TIme Recommenations266

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Pruritus

The number of subjects who experienced and self-reported pruritus within the first 24 hours after administration of spinal anesthesia. (NCT02789410)
Timeframe: 24 hours after administration of spinal anesthesia

InterventionParticipants (Count of Participants)
Intrathecal Hydromorphone27
Intrathecal Morphine28

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NRS Score for Pain (0-10) With Movement 24 Hours After Spinal Administration

Each patient will be interviewed by a member of the study team 24 hours after receiving their spinal anesthetic. Patients will be asked to rate their current level of pain on a Numeric Rating Scale (NRS) of 0 (no pain) to 10 (worst pain imaginable). (NCT02789410)
Timeframe: 24 hours after administration of spinal anesthesia

Interventionscore on a scale (Median)
Intrathecal Hydromorphone4
Intrathecal Morphine3

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Nausea

The number of subjects who experienced and self-reported nausea within the first 24 hours after administration of spinal anesthesia. (NCT02789410)
Timeframe: 24 hours after administration of spinal anesthesia

InterventionParticipants (Count of Participants)
Intrathecal Hydromorphone28
Intrathecal Morphine32

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Change From Baseline in Average Weekly Numeric Pain Rating Score (NRS)

"Average Weekly Numeric Pain Rating Score (NRS) over the past week~Numerical Rating Pain Scale (NRS): scale from 0-10 0 = no pain 10 = worst imaginable pain" (NCT02886286)
Timeframe: Day 0, 7, 14, score at day 7 or day 14 reported

Interventionunits on a scale (Mean)
Bupivacaine + Opioid-0.47
Opioid-0.38

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Change From Baseline in Oswestry Disability Index (ODI)

"Oswestry Disability Index (ODI): calculated as a percentage based on scores from 0-5 in 10 categories (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, travelling). 0 signifies no pain interference while 5 signifies maximum possible pain interference in the 10 categories. Scores from 0-5 for 10 categories are added and divided by total possible score (50) X 100 to give percentage.~Interpretation of percentage scores:~0 - 20% minimal disability 21-40% moderate disability 41-60% severe disability 61-80% crippled 81-100% either bed bound or patient is exaggerating symptoms" (NCT02886286)
Timeframe: Day 0, 7, 14, score at day 7 or day 14 reported

Interventionunits on a scale (Mean)
Bupivacaine + Opioid.88
Opioid2.67

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Change From Baseline in painDETECT

painDETECT is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain. A total score that ranges from -1 to 38 can be calculated from the nine items, with higher scores indicating higher levels of pain. (NCT02886286)
Timeframe: Day 0, 7, 14, score at day 7 or day 14 reported

Interventionunits on a scale (Mean)
Bupivacaine + Opioid0.69
Opioid0.25

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Change From Baseline in Patient Global Impression of Change (PGIC)

"Patient Global Impression of Change (PGIC): reflects patient's belief about the efficacy of treatment~= very much improved~= much improved~= minimally improved~= no change~= worse~= much worse~= very much worse" (NCT02886286)
Timeframe: Day 0, 7, 14, score at day 7 or day 14 reported

Interventionunits on a scale (Mean)
Bupivacaine + Opioid-0.06
Opioid1.25

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Change From Baseline in the Numerical Rating Pain Scale (NRS)

"Patients will be provided with a diary to record pain scores just before a PTM bolus and the lowest pain score within half an hour after a PTM bolus.~Numerical Rating Pain Scale (NRS): scale from 0-10 0 = no pain 10 = worst imaginable pain" (NCT02886286)
Timeframe: Before self-administered bolus using Patient Therapy Manager device (PTM) and within 30 minutes of PTM bolus

Interventionunits on a scale (Mean)
Bupivacaine + Opioid1.87
Opioid1.81

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Change From Baseline in Treatment Satisfaction

A 5-point qualitative Likert scale was used to report measures of patient satisfaction (i.e., not satisfied at all, not satisfied, somewhat, satisfied, very satisfied). To quantify satisfaction, these responses were transformed to a scale of 0-4, with higher numbers representing greater levels of satisfaction. (NCT02886286)
Timeframe: Day 0, 7, 14, score at day 7 or day 14 reported

Interventionunits on a scale (Mean)
Bupivacaine + Opioid2.36
Opioid1.94

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Length of Stay

Length of time from the end of surgery to discharge home from the hospital, assessed up to 1 week. (NCT03052816)
Timeframe: Time from end of surgery to discharge home from hospital, assessed up to 1 week.

Interventionhours (Mean)
ICE T24.1
STANDARD24.1

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Total Dose of Opioids Administered During Hospitalization

Total dose of opioids administered during hospitalization in morphine equivalents upon hospital discharge. (NCT03052816)
Timeframe: Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 week

Interventionmilligrams of oral morphine equivalents (Mean)
ICE T55.7
STANDARD91.2

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Satisfaction Scores in the Morning After Surgery (7AM)

Satisfaction scores in the morning after surgery (7AM). The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale. (NCT03052816)
Timeframe: Satisfaction scores in the morning after surgery (7AM)

Interventionscore on a scale (Median)
ICE T10
STANDARD10

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VAS Scores at 4 Hours Post Surgery

VAS Scores at 4 hours post surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm. (NCT03052816)
Timeframe: VAS Scores at 4 hours post surgery

Interventionmm (Median)
ICE T35
Standard50

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Satisfaction Scores 96 Hours After Surgery

Satisfaction scores 96 hours after surgery. The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale. (NCT03052816)
Timeframe: Satisfaction scores 96 hours after surgery

Interventionscore on a scale (Median)
ICE T10
STANDARD9

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Postoperative Nausea and Vomiting at 7AM After Surgery

Number of patients with postoperative nausea and vomiting at 7AM after surgery (NCT03052816)
Timeframe: Postoperative nausea and vomiting from the time to end of surgery until 7AM after surgery

InterventionParticipants (Count of Participants)
ICE T14
STANDARD18

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Quality of Recovery Scores on Post op Day 1

Quality of Recovery scores on post op day 1. The QoR-40 is a 40-item quality of recovery score measuring 5 dimensions: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). It was specifically designed to measure a patient's health status after surgery and anesthesia, and it has been proposed as a measure of outcome in clinical trials. (NCT03052816)
Timeframe: Quality of Recovery scores on post op day 1

Interventionscore on a scale (Median)
ICE T182
STANDARD173

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Visual Analog Scores (VAS)

Visual Analog Scores (VAS) Scores in the morning of post op day 1. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm. (NCT03052816)
Timeframe: Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.

Interventionmm (Median)
ICE T20
Standard40

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VAS Scores 96 Hours After Surgery

VAS Scores 96 hours after surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm. (NCT03052816)
Timeframe: VAS Scores 96 hours after surgery

Interventionmm (Median)
ICE T20
STANDARD30

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Number of Participants With Urinary Retention.

Number of participants with urinary retention (discharge home with foley) (NCT03052816)
Timeframe: Number of participants with urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week.

InterventionParticipants (Count of Participants)
ICE T5
STANDARD7

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Postoperative Opioid Use

Determine the impact of administering a supplemental non-opioid analgesic drug such as IV/oral acetaminophen on total opioid dose administered over the perioperative period. (NCT03104816)
Timeframe: Within 24 hours after surgery

,,
Interventionmg (Mean)
PACU doseWard dose
Acetaminophen IV Soln 10 MG/ML (A)1.29.8
Hydromorphone (Control Arm) (C)1.713
PO Acetaminophen (B)1.310.4

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Visual Analog Pain Score (VAS)

Postoperative Visual Analog Pain Score following lumbar fusion surgery. VAS on the scale 0 to 100 (0= no pain, 100= worst pain). (NCT03115151)
Timeframe: VAS score at postoperative 24 hours

Interventionunits on a scale (Mean)
Patient-Controlled Epidural Analgesia40.23
Intravenous Patient-controlled Analgesia54.27

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Average Sedation Scores Over 72 Hours

Sedation scores will be documented by a study team member post operatively up to 3 days per protocol requirements. Determining if patient is 0=awake and alert, 1=quietly awake, 2=asleep and arousable, or 3=deep sleep. (NCT03151434)
Timeframe: Sedation scores will be documented at 1 hour post op, 24,48,and 72 hours after the sugery. The scores will then be averaged.

Interventionunits on a scale (Mean)
Group #10.38
Group #20.32
Group #30.22

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Average Nausea Scores Over 72 Hours

Nausea scores will be collected by a study team member post operatively up to 3 days per protocol. Nausea will be recorded as 0=none, 1=mild, 2=moderate, or 3=severe (NCT03151434)
Timeframe: Nausea scores will be documented at 1 hour post op, 24,48,and 72 hours after the surgery.The scores will then be averaged.

Interventionunits on a scale (Mean)
Group #10.27
Group #20.27
Group #30.29

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Subjects Overall Satisfaction Scores

Subjects will be followed up at 24 hours post operatively by a study team member to document patient overall satisfaction scores. Score was recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied. (NCT03151434)
Timeframe: post operatively at hour 24

Interventionunits on a scale (Mean)
Group #10.89
Group #20.95
Group #31.33

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The Primary Endpoint of This Study Will be VAS Pain Score at 24 Hours

"The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using units on a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain" (NCT03151434)
Timeframe: Pain scores will be measured 24 hours after surgery.

Interventionunits on a scale (Median)
US Guided Single Shot Paravertebral Block4.0
US Guided Paravertebral Catheter4.5
Thoracic Epidural3.0

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The Primary Endpoint of This Study Will be VAS Pain Score at 48 Hours

"The VAS scores will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Usingunits on a scale scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain" (NCT03151434)
Timeframe: Pain scores will be measured 48 hours after surgery.

Interventionunits on a scale (Median)
US Guided Single Shot Paravertebral Block3.0
US Guided Paravertebral Catheter4.0
Thoracic Epidural2.0

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Secondary Endpoint Includes Total Intravenous Opioid Consumption at 72 Hours

Opioid consumption will be collected by a study team member post operatively up to 3 days per protocol time requirements (NCT03151434)
Timeframe: Opioid consumption will be measured at 1 hour post op, 24,48, and 72 hours post op. The total amount will be recorded.

Interventionmiligram morphine equivalent (Median)
Group #157
Group #235
Group #321.3

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Subjects Overall Satisfaction Scores

Subjects will be followed up at 48 hours post operatively by a study team member to document patient overall satisfaction scores. Scores will be recorded as 0=dissatisfied, 1=satisfied, 2=very satisfied. (NCT03151434)
Timeframe: post operatively at hour 48

Interventionunits on a scale (Mean)
Group #11.19
Group #21.05
Group #31.32

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Change in 0-10 Pain Scale Between Baseline and 90 Minutes

Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable (NCT03300674)
Timeframe: up to 90 minutes

Interventionunits on a scale (Mean)
Intravenous Hydromorphone5.0
Intravenous Lidocaine3.8

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Adverse Events

Any new symptom development after administration of investigational medication (NCT03300674)
Timeframe: 4 hours

InterventionParticipants (Count of Participants)
Intravenous Hydromorphone28
Intravenous Lidocaine23

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Rescue Medication

no need for off-protocol parenteral pain medication during the ED visit. The following parenteral medications will be considered off protocol pain medication: any opioid, any non-steroidal anti-inflammatory drug (NCT03300674)
Timeframe: 4 hours

InterventionParticipants (Count of Participants)
Intravenous Hydromorphone20
Intravenous Lidocaine39

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"Positive Subjective Drug Effects (i.e., Drug Liking)."

"The positive subjective effects of the most efficacious dose of the intravenous challenge drugs. These are measured using self-reported assessment by the participant in terms of drug liking rated on a visual analog scale of 0-100. Higher values indicate a greater drug effect." (NCT03389750)
Timeframe: Throughout study enrollment period (8-9 weeks)

Interventionunits on a scale (Mean)
IV Placebo52.1
IV Oxymorphone 1.8 mg57.5
IV Oxymorphone 3.2 mg71.8
IV Oxymorphone 5.6 mg71.5
IV Oxymorphone 10 mg84
IV Hydromorphone 3.2 mg66.3
IV Hydromorphone 5.6 mg71.3
IV Hydromorphone 10 mg84.3
IV Hydromorphone 18 mg79.6
IV Oxycodone 10 mg59.5
IV Oxycodone 18 mg63.3
IV Oxycodone 32 mg70.3
IV Oxycodone 56 mg79.1

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Clinical Improvement in NRS Pain Score

"Pain improvement was assessed using an NRS (numeric rating scale) to assess pain on a range of 0-10. Participants were asked to verbalize intensity of pain on the scale with zero meaning no pain and 10 meaning the worst pain imaginable. Pain was assessed at baseline and 60 minutes later to determine if clinically important improvement in pain was achieved. Clinically important improvement in pain was defined as an improvement of >=1.3 points on the 0-10 scale." (NCT03521102)
Timeframe: 60 minutes following administration of medication

InterventionParticipants (Count of Participants)
Acetaminophen 1000mg IV62
Hydromorphone 0.5mg IV63

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Improvement in NPS Pain Score by >=50%

The number of patients who minimally achieved a 50% improvement in NPS pain score from 0 to 60 minutes. (NCT03521102)
Timeframe: 60 minutes after administration of medication

InterventionParticipants (Count of Participants)
Acetaminophen 1000mg IV30
Hydromorphone 0.5mg IV43

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Need for Rescue Medication

Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course. (NCT03521102)
Timeframe: 120 minutes following administration of medication

InterventionParticipants (Count of Participants)
Acetaminophen 1000mg IV37
Hydromorphone 0.5mg IV31

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Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment

The between group difference in change in NRS pain scores from before administration of study medications to 60 minutes post administration of study medications. The NRS is a previously validated and reproducible measure of pain intensity ranging from 0 = no pain, to 10 = worst possible pain. Higher values indicate more pain relief from before treatment to 60 minutes after treatment (NCT03553498)
Timeframe: Before treatment to 60 minutes after treatment

Interventionunits on a scale (Mean)
IV Hydromorphone and IV Acetaminophen6.2
IV Hydromorphone and Placebo5.4

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Percentage of Patients Who Want Additional Analgesics

"Number of patients who answer yes to question: Do you want more pain medication divided by number of patients" (NCT03553498)
Timeframe: Immediately after administration of study medication to 120 minutes after administration of study medication

InterventionParticipants (Count of Participants)
IV Hydromorphone and IV Acetaminophen21
IV Hydromorphone and Placebo29

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Percentage of Patients Who Received Additional Pain Medication Within 60 Minutes of Administration of Study Medication

Difference in percentage of patients who received additional pain medication within 60 minutes of administration of study medication in the two arms of the study (NCT03553498)
Timeframe: Baseline to 60 minutes post-baseline

InterventionParticipants (Count of Participants)
IV Hydromorphone and IV Acetaminophen2
IV Hydromorphone and Placebo2

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Percentage of Patients Who Received Additional Pain Medication Between 61 and 120 Minutes After Administration of Study Medications

Difference in percentage of patients who received additional pain medication between 61 and 120 minutes after administration of study medication by study group (NCT03553498)
Timeframe: 61 to 120 minutes post-baseline

InterventionParticipants (Count of Participants)
IV Hydromorphone and IV Acetaminophen2
IV Hydromorphone and Placebo4

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Time to Opioid Cessation or Freedom

Time to the last use of opioid (NCT03789318)
Timeframe: From Surgery to Day 17

Interventionhours (Median)
CA-008 5 mg (0.05 mg/mL) Cohort 156.37
Placebo for Cohort 155.42
CA-008 10 mg (0.1 mg/mL)83.89
CA-008 15 mg (0.15 mg/mL)59.55
Placebo for Cohorts 2 and 342.26

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Total Opioid Consumption

The sum of daily opioid consumption (in morphine equivalents) (NCT03789318)
Timeframe: 0 to 96 hours

Interventionmg morphine equivalents (Mean)
CA-008 5 mg (0.05 mg/mL) Cohort 185.83
Placebo for Cohort 196.67
CA-008 10 mg (0.1 mg/mL)69.77
CA-008 15 mg (0.15 mg/mL)58.00
Placebo for Cohorts 2 and 377.85

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Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores

Pain intensity scores (using a Numeric Rating Scale of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable) from 0 to T96 hours (NCT03789318)
Timeframe: 0 to 96 hours

Interventionscore on a scale*hours (Mean)
CA-008 5 mg (0.05 mg/mL) Cohort 1392.98
Placebo for Cohort 1392.67
CA-008 10 mg (0.1 mg/mL)384.94
CA-008 15 mg (0.15 mg/mL)406.88
Placebo for Cohorts 2 and 3356.23

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Pain Intensity Scores at 96 Hours at Rest Using Numerical Rating Scale (NRS)

Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 96 hours (NCT03789318)
Timeframe: 96 hours

Interventionscore on a scale (Mean)
CA-008 5 mg (0.05 mg/mL) Cohort 12.8
Placebo for Cohort 12.0
CA-008 10 mg (0.1 mg/mL)3.0
CA-008 15 mg (0.15 mg/mL)2.8
Placebo for Cohorts 2 and 31.8

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Percent of Opioid Free Subjects

Percent of subjects who were opioid free at 0-96 hours (NCT03789318)
Timeframe: 0 to 96 hours

InterventionParticipants (Count of Participants)
CA-008 5 mg (0.05 mg/mL) Cohort 10
Placebo for Cohort 10
CA-008 10 mg (0.1 mg/mL)1
CA-008 15 mg (0.15 mg/mL)1
Placebo for Cohorts 2 and 30

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Length of Care

Length of care from bed placement to last drug dose in hours. (NCT03933397)
Timeframe: up to 6 hours

Interventionhours (Mean)
Patient-Specific Protocol2.5
Weight-based Protocol2.6

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Length of Index ED (Emergency Department) Stay

Length of index ED stay in hours from bed placement to discharge (NCT03933397)
Timeframe: From bed placement to discharge or 6 hours whichever comes first

Interventionhours (Mean)
Patient-Specific Protocol3.4
Weight-based Protocol4.2

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The Change in Pain Score

Pain is measured by having the patient mark pain on a scale of 0 to 100, with 0 being no pain and 100 being the worst pain ever. Pain scores were initially measured using a 0-100 millimeter visual analog scale with higher (closer to 100 being worse); however during the COVID-19 pandemic, one site removed paper forms from the emergency department as an infection control measure. The protocol was amended to add collection of a 0-100 verbal numerical rating scale and sites were ask to obtain both a vision and verbal score if possible collecting the visual score first. For the analysis, the visual score was used if available for the primary outcome. if not available, the verbal score was used. (NCT03933397)
Timeframe: baseline (bed placement), to disposition decision or a maximum treatment duration of 6 hours, whichever came first

Interventionscore on a scale (Mean)
Patient-Specific Protocol-27.0
Weight-based Protocol-27.6

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Number of Participants Experiencing Side Effects

Side effects and safety at any time during the emergency department visit (NCT03933397)
Timeframe: Bed placement to discharge or 6 hours, whichever comes first

,
InterventionParticipants (Count of Participants)
NauseavomitingpruritusSPO2<95% requiring supplemental oxygen via nasal cannula due to opioid therapyModerate to severe sedation (sedation score of >=3Drowsinessrespiratory depression not requiring intubationLow blood pressure (SBP,90mmHg and/or DBP<50mmHg
Patient-Specific Protocol19731441503
Weight-based Protocol1963675911

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Total Number of Hospitalizations for Vaso-Occlusive Episode 7 Days Post Enrollment

Number of hospitalizations for Vaso-Occlusive Episode (VOE) within 7 days following enrollment (NCT03933397)
Timeframe: Up to 7 days post enrollment

Interventionhospitalizations (Number)
Patient-Specific Protocol11
Weight-based Protocol14

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Pain Scores

Subjective, Score 0-10 with 0 being no pain and 10 being severe pain (NCT04429022)
Timeframe: 0-3 hours after surgery

Interventionscore on a scale (Mean)
Prospective Cohort3.82
Historical Control5.13

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Length of Stay in Hours

Length of stay in hours (NCT04429022)
Timeframe: 0- 240 hours

Interventionhours (Mean)
Prospective Cohort12.05
Historical Control35.82

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Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period

Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period (NCT04429022)
Timeframe: 0-14 days

InterventionParticipants (Count of Participants)
Prospective Cohort1
Historical Control3

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Operative Time

minutes (NCT04429022)
Timeframe: 0-300 minutes

Interventionminutes (Mean)
Prospective Cohort128.80
Historical Control139.69

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Pain Scores

Subjective, Score 0-10 with 0 being no pain and 10 being severe pain (NCT04429022)
Timeframe: 3-24 hours after surgery

Interventionscore on a scale (Mean)
Prospective Cohort1.75
Historical Control5.43

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Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)

Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME) (NCT04429022)
Timeframe: 0-3 hours after surgery

Interventionmorphine milligram equivalents (MME) (Mean)
Prospective Cohort2.00
Historical Control5.32

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Total Opioid Pain Medications Required Through 3-24h Post op in MME

Total opioid pain medications required through 3-24h post op in MME (NCT04429022)
Timeframe: 3-24 hours after surgery

Interventionmorphine milligram equivalents (MME) (Mean)
Prospective Cohort.20
Historical Control12.27

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Estimated Blood Loss

milliliters (mL) (NCT04429022)
Timeframe: 0-300 minutes

Interventionmilliliters (Mean)
Prospective Cohort63.50
Historical Control58.46

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