Page last updated: 2024-10-27

fentanyl and Constipation

fentanyl has been researched along with Constipation in 32 studies

Fentanyl: A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078)
fentanyl : A monocarboxylic acid amide resulting from the formal condensation of the aryl amino group of N-phenyl-1-(2-phenylethyl)piperidin-4-amine with propanoic acid.

Constipation: Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections.

Research Excerpts

ExcerptRelevanceReference
"To compare the efficacy and safety of transdermal fentanyl (TDF) and sustained release morphine (SRM) in strong-opioid naïve patients with chronic low back pain (CLBP)."9.11Transdermal fentanyl versus sustained release oral morphine in strong-opioid naïve patients with chronic low back pain. ( Allan, L; Richarz, U; Simpson, K; Slappendel, R, 2005)
"Constipation and the use of laxatives were investigated in patients with chronic cancer pain treated with oral morphine and transdermal fentanyl in an open sequential trial."9.09Constipation and the use of laxatives: a comparison between transdermal fentanyl and oral morphine. ( Grond, S; Kasper, M; Kulbe, C; Lehmann, KA; Loick, G; Radbruch, L; Sabatowski, R, 2000)
"Transdermal Fentanyl (TF, Durogesic) is a strong opioid analgesic which is used in the treatment of cancer pain."9.09[Research from the Palliative Care Department in Poznań on treatment of neoplasm pain with Durogesic (transdermal fentanyl)]. ( Gorzelińska, L; Kozikowska, J; Leppert, W; Luczak, J, 2000)
"The findings indicate comparability of transdermal buprenorphine and transdermal fentanyl for pain measures with significantly fewer adverse events (nausea and treatment discontinuation due to adverse events) caused by transdermal buprenorphine."8.88Systematic review of efficacy and safety of buprenorphine versus fentanyl or morphine in patients with chronic moderate to severe pain. ( Aune, D; Hernandez, AV; Kleijnen, J; Misso, K; Riemsma, R; Truyers, C; Wolff, RF, 2012)
" Compared with other opioids, low-dose fentanyl has been suggested to produce milder side effects such as nausea, constipation, and somnolence."7.77[Direct low-dose fentanyl patch (2.1mg) introduction for opioid naïve outpatients with cancer pain]. ( Fujita, S; Fukae, M; Hata, A; Iwamori, S; Kaji, R; Katakami, N; Masuda, Y; Mifune, Y; Nanjo, S; Orita, H; Otsuka, K; Yamatani, T, 2011)
" The following data points were collected before and after each naloxone dose; blood pressure, heart rate, respiratory rate, RASS score, pain assessment score (recorded as present or absent), midazolam dose, propofol dose and fentanyl dose."7.75Safety of enteral naloxone for the reversal of opiate-induced constipation in the intensive care unit. ( Arpino, PA; Thompson, BT, 2009)
"The fentanyl transdermal matrix patch is approved in Japan for the management of moderate to severe cancer-related pain in adults."7.74Fentanyl transdermal matrix patch (Durotep MT patch; Durogesic DTrans; Durogesic SMAT): in adults with cancer-related pain. ( Hoy, SM; Keating, GM, 2008)
"TTS-fentanyl can be applied as long-term therapy to patients with cancer-related pain, including the elderly."7.71Longitudinal follow-up of TTS-fentanyl use in patients with cancer-related pain: results of a compassionate-use study with special focus on elderly patients. ( Desmedt, M; Lossignol, D; Menten, J; Mullie, A, 2002)
" In all patient groups, immediate-release oral morphine was the rescue analgesic and lactulose 10 mL twice daily was the prophylaxis of constipation; no antiemetics were used as prophylaxis."5.24A comparison of oral controlled-release morphine and oxycodone with transdermal formulations of buprenorphine and fentanyl in the treatment of severe pain in cancer patients. ( Leppert, W; Nosek, H; Nosek, K; Onichimowski, D; Wordliczek, J, 2017)
"The purpose of this trial was to evaluate the effect of long-term treatment with oral sustained-release hydromorphone, transdermal fentanyl, and transdermal buprenorphine on nausea, emesis and constipation."5.14Gastrointestinal symptoms under opioid therapy: a prospective comparison of oral sustained-release hydromorphone, transdermal fentanyl, and transdermal buprenorphine. ( Kloecker, N; Mueller, M; Nadstawek, J; Schaefer, N; Schenk, M; Schroeck, A; Standop, J; Wirz, S; Wittmann, M, 2009)
"This study aimed to (1) evaluate the psychometric properties of PAC-SYM in assessing the symptoms and severity of opioid-induced constipation; (2) test for differences in opioid-induced constipation between Durogesic fentanyl transdermal reservoir (TDF) and oral sustained-release morphine (SRM) in patients with chronic low back pain (CLBP)."5.12Validation of the PAC-SYM questionnaire for opioid-induced constipation in patients with chronic low back pain. ( Dubois, D; Keininger, DL; Simpson, K; Slappendel, R, 2006)
"To compare the efficacy and safety of transdermal fentanyl (TDF) and sustained release morphine (SRM) in strong-opioid naïve patients with chronic low back pain (CLBP)."5.11Transdermal fentanyl versus sustained release oral morphine in strong-opioid naïve patients with chronic low back pain. ( Allan, L; Richarz, U; Simpson, K; Slappendel, R, 2005)
"Constipation and the use of laxatives were investigated in patients with chronic cancer pain treated with oral morphine and transdermal fentanyl in an open sequential trial."5.09Constipation and the use of laxatives: a comparison between transdermal fentanyl and oral morphine. ( Grond, S; Kasper, M; Kulbe, C; Lehmann, KA; Loick, G; Radbruch, L; Sabatowski, R, 2000)
"Transdermal Fentanyl (TF, Durogesic) is a strong opioid analgesic which is used in the treatment of cancer pain."5.09[Research from the Palliative Care Department in Poznań on treatment of neoplasm pain with Durogesic (transdermal fentanyl)]. ( Gorzelińska, L; Kozikowska, J; Leppert, W; Luczak, J, 2000)
"The findings indicate comparability of transdermal buprenorphine and transdermal fentanyl for pain measures with significantly fewer adverse events (nausea and treatment discontinuation due to adverse events) caused by transdermal buprenorphine."4.88Systematic review of efficacy and safety of buprenorphine versus fentanyl or morphine in patients with chronic moderate to severe pain. ( Aune, D; Hernandez, AV; Kleijnen, J; Misso, K; Riemsma, R; Truyers, C; Wolff, RF, 2012)
"According to the World Health Organization (WHO) guidelines for patients with moderate or severe pain, morphine has been used as a "gold standard" treatment for cancer pain."4.82[Basic studies on cancer pain control]. ( Narita, M; Niikura, K; Ozaki, M; Suzuki, T; Yajima, Y, 2005)
"Antinociceptive actions of NFEPP and fentanyl were compared in control mice and mice with dextran sodium sulfate colitis by measuring visceromotor responses to colorectal distension."4.12Agonist that activates the µ-opioid receptor in acidified microenvironments inhibits colitis pain without side effects. ( Bok, DD; Bunnett, NW; Degro, C; Guzman-Rodriguez, M; Jaramillo-Polanco, JO; Jensen, DD; Jiménez-Vargas, NN; Latorre, R; Lomax, AE; Lopez, C; Margolis, KG; Reed, DE; Schmidt, BL; Snow, Z; Stein, C; Tsang, Q; Vanner, SJ; Wisdom, M; Yu, Y, 2022)
" In this study we evaluated the development and treatment of opioid induced constipation (OIC), and OIC resolving effect of methylnaltrexone for different opioid subtypes in daily clinical practice."3.91Optimal treatment of opioid induced constipation in daily clinical practice - an observational study. ( Beeker, A; Berkhof, J; Neefjes, ECW; Rhodius, CA; Ten Oever, D; van den Berg, HP; van der Vliet, HJ; van der Vorst, MJDL; van der Wijngaart, H; Verheul, HMW, 2019)
" Compared with other opioids, low-dose fentanyl has been suggested to produce milder side effects such as nausea, constipation, and somnolence."3.77[Direct low-dose fentanyl patch (2.1mg) introduction for opioid naïve outpatients with cancer pain]. ( Fujita, S; Fukae, M; Hata, A; Iwamori, S; Kaji, R; Katakami, N; Masuda, Y; Mifune, Y; Nanjo, S; Orita, H; Otsuka, K; Yamatani, T, 2011)
" The following data points were collected before and after each naloxone dose; blood pressure, heart rate, respiratory rate, RASS score, pain assessment score (recorded as present or absent), midazolam dose, propofol dose and fentanyl dose."3.75Safety of enteral naloxone for the reversal of opiate-induced constipation in the intensive care unit. ( Arpino, PA; Thompson, BT, 2009)
"The fentanyl transdermal matrix patch is approved in Japan for the management of moderate to severe cancer-related pain in adults."3.74Fentanyl transdermal matrix patch (Durotep MT patch; Durogesic DTrans; Durogesic SMAT): in adults with cancer-related pain. ( Hoy, SM; Keating, GM, 2008)
"In this population, patients receiving transdermal fentanyl had a lower risk of developing constipation compared with those receiving oxycodone CR or morphine CR."3.72Incidence of constipation associated with long-acting opioid therapy: a comparative study. ( Markowitz, J; Schein, J; Staats, PS, 2004)
"TTS-fentanyl can be applied as long-term therapy to patients with cancer-related pain, including the elderly."3.71Longitudinal follow-up of TTS-fentanyl use in patients with cancer-related pain: results of a compassionate-use study with special focus on elderly patients. ( Desmedt, M; Lossignol, D; Menten, J; Mullie, A, 2002)
"TTS fentanyl was shown to be an effective, safe and simple method for long-term pain relief in cancer patients and presents an interesting novel option in the treatment of cancer pain."2.68Transdermal fentanyl in combination with initial intravenous dose titration by patient-controlled analgesia. ( Lehmann, KA; Zech, DF, 1995)
"Although opioids have been shown to be effective for cancer pain, opioid-induced adverse events (AEs) are common."1.91Prevalence 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)
"Opioid-induced constipation is the most prevalent adverse effect of opioid drugs."1.62Pharmacological characterization of naloxegol: In vitro and in vivo studies. ( Calò, G; Costanzini, A; De Giorgio, R; Malfacini, D; Neto, JA; Ruzza, C; Sternini, C; Sturaro, C, 2021)
"Antinociception, constipation and respiratory depression were assessed using the warm water tail-flick test, the castor oil-induced diarrhoea test and whole body plethysmography respectively."1.42In vivo profiling of seven common opioids for antinociception, constipation and respiratory depression: no two opioids have the same profile. ( Kuo, A; Meutermans, W; Smith, MT; Wyse, BD, 2015)
"IV-PCA provided timely, safe and useful analgesia for patients with severe breakthrough pain and may be useful to help titration of opioids, weaning to oral analgesia and to decide for interventional procedures."1.40Safety profile of intravenous patient-controlled analgesia for breakthrough pain in cancer patients: a case series study. ( Ashmawi, HA; Cascudo, GM; de Santana Neto, J; Guimaraes, GM; Neto, JO; Sousa, AM, 2014)
"Basing on the components and the endurable dosage of each component for children, we formulated the appropriate dosage and usage of a few analgesics (including sustained release tablets of morphine, oxycodone and transdermal fantanyl) available in China, most of which were used in adults."1.34[Feasibility to treat pediatric cancer pain with analgesics for adults and their efficacy]. ( Lin, H; Ling, JY; Luo, WB; Sun, XF; Xia, Y; Zhen, ZJ; Zheng, L, 2007)

Research

Studies (32)

TimeframeStudies, this research(%)All Research%
pre-19902 (6.25)18.7374
1990's2 (6.25)18.2507
2000's12 (37.50)29.6817
2010's12 (37.50)24.3611
2020's4 (12.50)2.80

Authors

AuthorsStudies
Kondo, A1
Murakami, T1
Fujii, T1
Tatsumi, M1
Ueda-Sakane, Y1
Ueda, Y1
Yamauchi, I1
Ogura, M1
Taura, D1
Inagaki, N1
Hiratsuka, Y1
Tagami, K1
Inoue, A1
Sato, M1
Matsuda, Y1
Kosugi, K1
Kubo, E1
Natsume, M1
Ishiki, H1
Arakawa, S1
Shimizu, M1
Yokomichi, N1
Chiu, SW1
Shimoda, M1
Hirayama, H1
Nishijima, K1
Ouchi, K1
Shimoi, T1
Shigeno, T1
Yamaguchi, T1
Miyashita, M1
Morita, T1
Satomi, E1
Jiménez-Vargas, NN1
Yu, Y1
Jensen, DD1
Bok, DD1
Wisdom, M1
Latorre, R1
Lopez, C1
Jaramillo-Polanco, JO1
Degro, C1
Guzman-Rodriguez, M1
Tsang, Q1
Snow, Z1
Schmidt, BL1
Reed, DE1
Lomax, AE1
Margolis, KG1
Stein, C2
Bunnett, NW1
Vanner, SJ1
Costanzini, A1
Ruzza, C1
Neto, JA1
Sturaro, C1
Malfacini, D1
Sternini, C1
De Giorgio, R1
Calò, G1
Nosek, K1
Leppert, W2
Nosek, H1
Wordliczek, J1
Onichimowski, D1
Neefjes, ECW1
van der Wijngaart, H1
van der Vorst, MJDL1
Ten Oever, D1
van der Vliet, HJ1
Beeker, A1
Rhodius, CA1
van den Berg, HP1
Berkhof, J1
Verheul, HMW1
Gálvez, R1
Schäfer, M1
Hans, G1
Falke, D1
Steigerwald, I1
Sousa, AM1
de Santana Neto, J1
Guimaraes, GM1
Cascudo, GM1
Neto, JO1
Ashmawi, HA1
Kuo, A1
Wyse, BD1
Meutermans, W1
Smith, MT1
Domingo-Triadó, V1
López Alarcón, MD1
Villegas Estévez, F1
Alba Moratillas, C1
Massa Domínguez, B1
Palomares Payá, F1
Mínguez Martí, A1
Debón Vicent, L1
López-Pérez, FJ1
Mínguez-Martí, A1
Vicario-Sánchez, E1
Pastor-Clérigues, A1
Sanfeliu-García, J1
Ortega-García, MP1
Merchan, C1
Altshuler, D1
Papadopoulos, J1
Spahn, V1
Del Vecchio, G1
Labuz, D1
Rodriguez-Gaztelumendi, A1
Massaly, N1
Temp, J1
Durmaz, V1
Sabri, P1
Reidelbach, M1
Machelska, H1
Weber, M1
Hoy, SM1
Keating, GM1
Wirz, S1
Wittmann, M1
Schenk, M1
Schroeck, A1
Schaefer, N1
Mueller, M1
Standop, J1
Kloecker, N1
Nadstawek, J1
Arpino, PA1
Thompson, BT1
Hata, A1
Katakami, N1
Masuda, Y1
Nanjo, S1
Otsuka, K1
Kaji, R1
Fujita, S1
Iwamori, S1
Mifune, Y1
Orita, H1
Fukae, M1
Yamatani, T1
Nakamura, A1
Hasegawa, M1
Ito, H1
Minami, K1
Koike, K1
Habu-Tomita, N1
Nanba, K1
Hamaguchi, K1
Noshi, E1
Hashimoto, H1
Nishino, I1
Okabayashi, Y1
Koyabu, K1
Kihara, T1
Iwamoto, Y1
Inoue, Y1
Narita, M2
Suzuki, T2
Kato, A1
Wolff, RF1
Aune, D1
Truyers, C1
Hernandez, AV1
Misso, K1
Riemsma, R1
Kleijnen, J1
Menten, J1
Desmedt, M1
Lossignol, D1
Mullie, A1
GARDOCKI, JF1
YELNOSKY, J1
Staats, PS1
Markowitz, J1
Schein, J1
Radbruch, L2
Elsner, F1
Slappendel, R2
Simpson, K2
Dubois, D1
Keininger, DL1
Yajima, Y1
Ozaki, M1
Niikura, K1
Allan, L1
Richarz, U1
Zhen, ZJ1
Sun, XF1
Xia, Y1
Ling, JY1
Zheng, L1
Luo, WB1
Lin, H1
Zech, DF1
Lehmann, KA2
Davies, A1
Prentice, W1
Sabatowski, R1
Loick, G1
Kulbe, C1
Kasper, M1
Grond, S1
Luczak, J1
Gorzelińska, L1
Kozikowska, J1
Péceli, E1
Seres, G1

Clinical Trials (6)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Clinical Evaluation of the Efficacy of Methylnaltrexone in Resolving Constipation Induced by Different Opioid Subtypes, Combined With Laboratory Analysis of Immunomodulatory and Antiangiogenic Effects of Methylnaltrexone[NCT01955213]7 participants (Actual)Observational2012-07-31Terminated
An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Severe Chronic Nociceptive, Mixed or Neuropathic Low Back Pain Taking WHO Step II[NCT00986258]Phase 3136 participants (Actual)Interventional2009-10-30Terminated (stopped due to This clinical trial was terminated early, due to slow recruitment and study drug shortages.)
Methylnaltrexone for the Reversal of Opiate-Induced Constipation in the Intensive Care Unit[NCT01050595]Phase 380 participants (Anticipated)Interventional2009-12-31Recruiting
The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus[NCT03176316]Phase 4150 participants (Anticipated)Interventional2018-01-02Recruiting
Assessing the Content Validity of a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation[NCT01645371]79 participants (Actual)Observational2012-08-31Completed
Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicentre, Interventional Clinical Trial to Assess the Efficacy and Safety of the Food Supplement Microsmin® Plus in the Symptomatic Treatment of Haemorrhoids[NCT05750563]80 participants (Anticipated)Interventional2023-02-28Not yet recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Average Pain Intensity Before the Start of Tapentadol Treatment

"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine." (NCT00986258)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Tapentadol Prolonged Release4.8

Change in Average Pain Intensity After 12 Weeks of Tapentadol Prolonged Release Treatment.

"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity." (NCT00986258)
Timeframe: Baseline; End of Week 12 (12 weeks)

Interventionunits on a scale (Mean)
Tapentadol Prolonged Release-1.3

Change in Average Pain Intensity After 6 Weeks of Tapentadol Prolonged Release Treatment.

"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A negative value indicates a reduction in pain intensity from the baseline average pain intensity." (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 weeks)

Interventionunits on a scale (Mean)
Tapentadol Prolonged Release-0.9

Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine

Tapentadol was compared to Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Buprenorphine. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

InterventionRatio (Number)
Tapentadol210.0

Mean Equipotency Ratio of Tapentadol Compared to Fentanyl

Tapentadol was compared to Transdermal Fentanyl with Fentanyl set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Fentanyl was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Fentanyl. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

InterventionRatio (Number)
Tapentadol250.7

Mean Equipotency Ratio of Tapentadol Compared to Hydromorphone

Tapentadol was compared to Hydromorphone with Hydromorphone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Hydromorphone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Hydromorphone. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

InterventionRatio (Number)
Tapentadol10.5

Mean Equipotency Ratio of Tapentadol Compared to Morphine

Tapentadol was compared to Morphine with Morphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Morphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Morphine. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

InterventionRatio (Number)
Tapentadol3.0

Mean Equipotency Ratio of Tapentadol Compared to Oxycodone

Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

InterventionRatio (Number)
Tapentadol5.3

Number of Participants That Responded to Treatment

Participants were considered responders if they reported the same or less average pain intensity over a 3 day period (NRS-3) after 6 weeks of tapentadol prolonged release treatment compared to their previous analgesic treatment (over a 3 day period on the Numeric Rating Scale) at Week 6 compared with Week-1. (NCT00986258)
Timeframe: 6 weeks

Interventionparticipants (Number)
Tapentadol Prolonged Release76

painDETECT Assessment at Baseline

"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear." (NCT00986258)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Baseline painDETECT Negative Group6.5
Baseline painDETECT Unclear Group14.7
Baseline painDETECT Positive Group21.1

painDETECT Assessment for Participants After 12 Weeks of Tapentadol Prolonged Release Treatment

"The baseline painDETECT score was reassessed at the end of Week 12.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear." (NCT00986258)
Timeframe: End of Week 12

Interventionunits on a scale (Mean)
Baseline painDETECT Negative Group6.8
Baseline painDETECT Unclear Group8.6
Baseline painDETECT Positive Group16.5

painDETECT Assessment for Participants After 6 Weeks of Tapentadol Prolonged Release Treatment

"The baseline painDETECT score was reassessed at the end of Week 6.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear." (NCT00986258)
Timeframe: End of Week 6

Interventionunits on a scale (Mean)
Baseline painDETECT Negative Group7.5
Baseline painDETECT Unclear Group10.5
Baseline painDETECT Positive Group17.4

Change in the Health Survey Scores Form (SF-36)

The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline. (NCT00986258)
Timeframe: Baseline; End of Week 12 (12 Weeks)

Interventionunits on a scale (Mean)
Physical FunctioningBodily PainGeneral HealthVitalitySocial FunctioningRole EmotionalMental HealthRole Physical
Tapentadol Prolonged Release10.514.15.712.011.713.99.810.7

Change in the Health Survey Scores Form (SF-36)

The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Interventionunits on a scale (Mean)
Physical FunctioningBodily PainGeneral HealthVitalitySocial FunctioningRole EmotionalMental HealthRole Physical
Tapentadol Prolonged Release8.411.65.99.28.0-1.45.16.9

Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score

"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean (average) for each neuropathic symptom in a sub-scale.~The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)." (NCT00986258)
Timeframe: End of Week 12

Interventionunits on a scale (Mean)
Sub-score burning painSub-score pressing painSub-score paroxysmal painSub-score evoked painSub-score paresthesia / dysthesiaOverall score
Tapentadol Prolonged Release0.270.3020.2540.2730.2990.280

Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score

"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean for each neuropathic symptom in a sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)." (NCT00986258)
Timeframe: End of Week 6

Interventionunits on a scale (Mean)
Sub-score burning painSub-score pressing painSub-score paroxysmal painSub-score evoked painSub-score paresthesia / dysthesiaOverall score
Tapentadol Prolonged Release0.320.3220.2710.2740.3020.297

Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score

"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean for each neuropathic symptom in the sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)." (NCT00986258)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Sub-score burning painSub-score pressing painSub-score paroxysmal painSub-score evoked painSub-score paresthesia / dysthesiaOverall score
Tapentadol Prolonged Release0.410.4050.4220.3850.4240.408

Patient Global Impression of Change

In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse. (NCT00986258)
Timeframe: Baseline; End of Week 12 (12 Weeks)

Interventionparticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Tapentadol Prolonged Release934389210

Patient Global Impression of Change

In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Interventionparticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Tapentadol Prolonged Release5294711630

Reviews

3 reviews available for fentanyl and Constipation

ArticleYear
Systematic review of efficacy and safety of buprenorphine versus fentanyl or morphine in patients with chronic moderate to severe pain.
    Current medical research and opinion, 2012, Volume: 28, Issue:5

    Topics: Administration, Oral; Analgesics, Opioid; Buprenorphine; Chronic Pain; Constipation; Fentanyl; Human

2012
Clinical experience with transdermal fentanyl for the treatment of cancer pain in Germany.
    The Keio journal of medicine, 2004, Volume: 53, Issue:1

    Topics: Administration, Cutaneous; Clinical Trials as Topic; Constipation; Fentanyl; Germany; Humans; Narcot

2004
[Basic studies on cancer pain control].
    Gan to kagaku ryoho. Cancer & chemotherapy, 2005, Volume: 32, Issue:10

    Topics: Analgesics, Opioid; Animals; Constipation; Dose-Response Relationship, Drug; Fentanyl; Humans; Morph

2005

Trials

9 trials available for fentanyl and Constipation

ArticleYear
A comparison of oral controlled-release morphine and oxycodone with transdermal formulations of buprenorphine and fentanyl in the treatment of severe pain in cancer patients.
    Drug design, development and therapy, 2017, Volume: 11

    Topics: Administration, Cutaneous; Administration, Oral; Aged; Aged, 80 and over; Analgesics, Opioid; Bupren

2017
Tapentadol prolonged release versus strong opioids for severe, chronic low back pain: results of an open-label, phase 3b study.
    Advances in therapy, 2013, Volume: 30, Issue:3

    Topics: Adult; Aged; Analgesics, Opioid; Buprenorphine; Chronic Pain; Constipation; Delayed-Action Preparati

2013
[Breakthrough pain treatment with sublingual fentanyl in patients with chronic cutaneous ulcers].
    Revista espanola de anestesiologia y reanimacion, 2014, Volume: 61, Issue:8

    Topics: Administration, Sublingual; Aged; Chronic Disease; Constipation; Female; Fentanyl; Humans; Male; Mid

2014
Gastrointestinal symptoms under opioid therapy: a prospective comparison of oral sustained-release hydromorphone, transdermal fentanyl, and transdermal buprenorphine.
    European journal of pain (London, England), 2009, Volume: 13, Issue:7

    Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Antiemetics; Buprenor

2009
Validation of the PAC-SYM questionnaire for opioid-induced constipation in patients with chronic low back pain.
    European journal of pain (London, England), 2006, Volume: 10, Issue:3

    Topics: Administration, Cutaneous; Administration, Oral; Adult; Aged; Aged, 80 and over; Analgesics, Opioid;

2006
Validation of the PAC-SYM questionnaire for opioid-induced constipation in patients with chronic low back pain.
    European journal of pain (London, England), 2006, Volume: 10, Issue:3

    Topics: Administration, Cutaneous; Administration, Oral; Adult; Aged; Aged, 80 and over; Analgesics, Opioid;

2006
Validation of the PAC-SYM questionnaire for opioid-induced constipation in patients with chronic low back pain.
    European journal of pain (London, England), 2006, Volume: 10, Issue:3

    Topics: Administration, Cutaneous; Administration, Oral; Adult; Aged; Aged, 80 and over; Analgesics, Opioid;

2006
Validation of the PAC-SYM questionnaire for opioid-induced constipation in patients with chronic low back pain.
    European journal of pain (London, England), 2006, Volume: 10, Issue:3

    Topics: Administration, Cutaneous; Administration, Oral; Adult; Aged; Aged, 80 and over; Analgesics, Opioid;

2006
Transdermal fentanyl versus sustained release oral morphine in strong-opioid naïve patients with chronic low back pain.
    Spine, 2005, Nov-15, Volume: 30, Issue:22

    Topics: Administration, Cutaneous; Administration, Oral; Analgesics, Opioid; Chronic Disease; Constipation;

2005
Transdermal fentanyl in combination with initial intravenous dose titration by patient-controlled analgesia.
    Anti-cancer drugs, 1995, Volume: 6 Suppl 3

    Topics: Administration, Cutaneous; Analgesia, Patient-Controlled; Analgesics; Constipation; Dose-Response Re

1995
Constipation and the use of laxatives: a comparison between transdermal fentanyl and oral morphine.
    Palliative medicine, 2000, Volume: 14, Issue:2

    Topics: Administration, Cutaneous; Administration, Oral; Adult; Aged; Aged, 80 and over; Analgesics, Opioid;

2000
[Research from the Palliative Care Department in Poznań on treatment of neoplasm pain with Durogesic (transdermal fentanyl)].
    Przeglad lekarski, 2000, Volume: 57, Issue:1

    Topics: Administration, Cutaneous; Administration, Oral; Adult; Aged; Aged, 80 and over; Analgesics, Opioid;

2000

Other Studies

20 other studies available for fentanyl and Constipation

ArticleYear
Opioid-induced adrenal insufficiency in transdermal fentanyl treatment: a revisited diagnosis in clinical setting.
    Endocrine journal, 2022, Feb-28, Volume: 69, Issue:2

    Topics: Adrenal Insufficiency; Analgesics, Opioid; Constipation; Female; Fentanyl; Humans; Middle Aged; Neop

2022
Prevalence of opioid-induced adverse events across opioids commonly used for analgesic treatment in Japan: a multicenter prospective longitudinal study.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2023, Oct-16, Volume: 31, Issue:12

    Topics: Analgesics, Opioid; Cancer Pain; Constipation; Delirium; Fentanyl; Humans; Hydromorphone; Japan; Lon

2023
Agonist that activates the µ-opioid receptor in acidified microenvironments inhibits colitis pain without side effects.
    Gut, 2022, Volume: 71, Issue:4

    Topics: Animals; Colitis; Colon; Colorectal Neoplasms; Constipation; Fentanyl; Humans; Inflammatory Bowel Di

2022
Pharmacological characterization of naloxegol: In vitro and in vivo studies.
    European journal of pharmacology, 2021, Jul-15, Volume: 903

    Topics: Administration, Oral; Analgesics, Opioid; Animals; Behavior, Animal; Calcium; CHO Cells; Constipatio

2021
Optimal treatment of opioid induced constipation in daily clinical practice - an observational study.
    BMC palliative care, 2019, Mar-29, Volume: 18, Issue:1

    Topics: Aged; Analgesics, Opioid; Constipation; Female; Fentanyl; Humans; Laxatives; Male; Middle Aged; Nalt

2019
Safety profile of intravenous patient-controlled analgesia for breakthrough pain in cancer patients: a case series study.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2014, Volume: 22, Issue:3

    Topics: Adult; Analgesia, Patient-Controlled; Analgesics; Breakthrough Pain; Constipation; Female; Fentanyl;

2014
In vivo profiling of seven common opioids for antinociception, constipation and respiratory depression: no two opioids have the same profile.
    British journal of pharmacology, 2015, Volume: 172, Issue:2

    Topics: Analgesics, Opioid; Animals; Benzeneacetamides; Buprenorphine; Castor Oil; Constipation; Diarrhea; E

2015
[Clinical experience in opioid switch for noncancer chronic pain treatment].
    Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria, 2014, Sep-16, Volume: 38, Issue:5

    Topics: Adjuvants, Pharmaceutic; Administration, Oral; Aged; Aged, 80 and over; Analgesia, Epidural; Analges

2014
Methylnaltrexone Versus Naloxone for Opioid-Induced Constipation in the Medical Intensive Care Unit.
    The Annals of pharmacotherapy, 2017, Volume: 51, Issue:3

    Topics: Adult; Analgesics, Opioid; Constipation; Critical Illness; Electronic Health Records; Female; Fentan

2017
A nontoxic pain killer designed by modeling of pathological receptor conformations.
    Science (New York, N.Y.), 2017, 03-03, Volume: 355, Issue:6328

    Topics: Acute Pain; Adenosine Monophosphate; Analgesia; Analgesics, Opioid; Animals; Computer Simulation; Co

2017
Fentanyl transdermal matrix patch (Durotep MT patch; Durogesic DTrans; Durogesic SMAT): in adults with cancer-related pain.
    Drugs, 2008, Volume: 68, Issue:12

    Topics: Administration, Cutaneous; Adult; Analgesics, Opioid; Area Under Curve; Clinical Trials, Phase II as

2008
Safety of enteral naloxone for the reversal of opiate-induced constipation in the intensive care unit.
    Journal of clinical pharmacy and therapeutics, 2009, Volume: 34, Issue:2

    Topics: Aged; Analgesics, Opioid; Constipation; Critical Care; Female; Fentanyl; Humans; Intubation, Gastroi

2009
Safety of enteral naloxone for the reversal of opiate-induced constipation in the intensive care unit.
    Journal of clinical pharmacy and therapeutics, 2009, Volume: 34, Issue:2

    Topics: Aged; Analgesics, Opioid; Constipation; Critical Care; Female; Fentanyl; Humans; Intubation, Gastroi

2009
Safety of enteral naloxone for the reversal of opiate-induced constipation in the intensive care unit.
    Journal of clinical pharmacy and therapeutics, 2009, Volume: 34, Issue:2

    Topics: Aged; Analgesics, Opioid; Constipation; Critical Care; Female; Fentanyl; Humans; Intubation, Gastroi

2009
Safety of enteral naloxone for the reversal of opiate-induced constipation in the intensive care unit.
    Journal of clinical pharmacy and therapeutics, 2009, Volume: 34, Issue:2

    Topics: Aged; Analgesics, Opioid; Constipation; Critical Care; Female; Fentanyl; Humans; Intubation, Gastroi

2009
[Direct low-dose fentanyl patch (2.1mg) introduction for opioid naïve outpatients with cancer pain].
    Gan to kagaku ryoho. Cancer & chemotherapy, 2011, Volume: 38, Issue:3

    Topics: Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Constipation; Female; Fentanyl; Humans; Male; Mi

2011
Distinct relations among plasma concentrations required for different pharmacological effects in oxycodone, morphine, and fentanyl.
    Journal of pain & palliative care pharmacotherapy, 2011, Volume: 25, Issue:4

    Topics: Analgesics; Analgesics, Opioid; Animals; Brain; Constipation; Dose-Response Relationship, Drug; Fent

2011
Longitudinal follow-up of TTS-fentanyl use in patients with cancer-related pain: results of a compassionate-use study with special focus on elderly patients.
    Current medical research and opinion, 2002, Volume: 18, Issue:8

    Topics: Administration, Cutaneous; Aged; Analgesics, Opioid; Constipation; Female; Fentanyl; Follow-Up Studi

2002
A STUDY OF SOME OF THE PHARMACOLOGIC ACTIONS OF FENTANYL CITRATE.
    Toxicology and applied pharmacology, 1964, Volume: 6

    Topics: Analgesics; Analgesics, Non-Narcotic; Antipyretics; Behavior, Animal; Blood Circulation; Blood Press

1964
Incidence of constipation associated with long-acting opioid therapy: a comparative study.
    Southern medical journal, 2004, Volume: 97, Issue:2

    Topics: Aged; Analgesics, Opioid; California; Constipation; Female; Fentanyl; Humans; Incidence; Male; Middl

2004
[Feasibility to treat pediatric cancer pain with analgesics for adults and their efficacy].
    Ai zheng = Aizheng = Chinese journal of cancer, 2007, Volume: 26, Issue:8

    Topics: Adolescent; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Child; Child, Preschool; Co

2007
Re: Fentanyl, morphine, and constipation.
    Journal of pain and symptom management, 1998, Volume: 16, Issue:3

    Topics: Analgesics, Opioid; Constipation; Diarrhea; Fentanyl; Humans; Morphine; Substance Withdrawal Syndrom

1998
[Use of neuroleptic analgesia in gynecological interventions].
    Zentralblatt fur Gynakologie, 1970, Feb-14, Volume: 92, Issue:7

    Topics: Adolescent; Adult; Aged; Benperidol; Blood Transfusion; Constipation; Diuresis; Female; Fentanyl; Ge

1970