acetaminophen and Long Sleeper Syndrome studies

Acetaminophen: Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
paracetamol : A member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group.

Research Excerpts

Excerpt	Relevance	Reference
"The results confirm the multisymptom benefit of a single dose of the test syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate and support its role as an effective and convenient therapy for symptoms of nasal congestion, runny nose, cough and pain/body aches associated with the common cold and for increasing sleep quality disturbed by the common cold."	9.12	Efficacy of a single evening dose of syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate in subjects with multiple common cold symptoms. ( Goodale, M; Grender, JM; Hull, JD; Jerdack, GR; Mizoguchi, H; Tyler, BA; Wilson, A, 2007)
"Acetaminophen is one of the most commonly used drugs during pregnancy globally."	8.12	Maternal use of acetaminophen during pregnancy and neurobehavioral problems in offspring at 3 years: A prospective cohort study. ( Kjerulff, KH; Sznajder, KK; Teti, DM, 2022)
"We studied the effects of two non-steroidal anti-inflammatory analgesics (NSAIAs), acetylsalicylic acid (ASA) and acetaminophen, on sleep patterns in rats with adjuvant-induced arthritis."	7.67	Differential effects of acetylsalicylic acid and acetaminophen on sleep abnormalities in a rat chronic pain model. ( Helms, C; Landis, CA; Levine, JD; Robinson, CR, 1989)
" Patients received stepwise pain treatment in which those who did not use analgesics were randomized to receive either paracetamol (3 g/day) or placebo tablets; those who already used pain treatment were allocated to buprenorphine transdermal system (max."	5.27	Effects of pain treatment on sleep in nursing home patients with dementia and depression: A multicenter placebo-controlled randomized clinical trial. ( Bjorvatn, B; Blytt, KM; Flo, E; Husebo, B, 2018)
"The results confirm the multisymptom benefit of a single dose of the test syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate and support its role as an effective and convenient therapy for symptoms of nasal congestion, runny nose, cough and pain/body aches associated with the common cold and for increasing sleep quality disturbed by the common cold."	5.12	Efficacy of a single evening dose of syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate in subjects with multiple common cold symptoms. ( Goodale, M; Grender, JM; Hull, JD; Jerdack, GR; Mizoguchi, H; Tyler, BA; Wilson, A, 2007)
"Acetaminophen is one of the most commonly used drugs during pregnancy globally."	4.12	Maternal use of acetaminophen during pregnancy and neurobehavioral problems in offspring at 3 years: A prospective cohort study. ( Kjerulff, KH; Sznajder, KK; Teti, DM, 2022)
"We studied the effects of two non-steroidal anti-inflammatory analgesics (NSAIAs), acetylsalicylic acid (ASA) and acetaminophen, on sleep patterns in rats with adjuvant-induced arthritis."	3.67	Differential effects of acetylsalicylic acid and acetaminophen on sleep abnormalities in a rat chronic pain model. ( Helms, C; Landis, CA; Levine, JD; Robinson, CR, 1989)
"The prevalence of sleep disorders increases with age."	2.79	Acetaminophen for self-reported sleep problems in an elderly population (ASLEEP): study protocol of a randomized placebo-controlled double-blind trial. ( de Rooij, SE; Hamburger, HL; Hooft, L; Kuper, IM; Tulen, JH; Tulner, LR; van de Glind, EM; van Munster, BC, 2014)
"This study examined the associations of sleep disorders with APAP-induced adverse reactions or liver injury and the possible mechanisms."	1.62	Sleep disorders are associated with acetaminophen-induced adverse reactions and liver injury. ( Fan, X; Han, Q; Li, N; Liu, Z; Wang, X; Zeng, L; Zhang, K; Zhang, X, 2021)
"Anxiety and depression are often also present."	1.35	Fibromyalgia: poorly understood; treatments are disappointing. ( , 2009)
" It is recommended to use the same dosages and dosage forms that the patient used before the trial, to start the trial with a run-in period, to formulate both general and individualized decision rules regarding the efficacy of treatment, to adjust treatment policies immediately after the trial, and to provide adequate instructions and support if treatment is adjusted."	1.33	Conducting research in individual patients: lessons learnt from two series of N-of-1 trials. ( de Vries, TP; Stalman, WA; van der Windt, DA; Wegman, AC, 2006)

Research

Studies (16)

Authors

Clinical Trials (19)

Trial Overview

Trial Outcomes

OOWS Score

Timeframe	Studies, this research(%)	All Research%
pre-1990	3 (18.75)	18.7374
1990's	0 (0.00)	18.2507
2000's	6 (37.50)	29.6817
2010's	5 (31.25)	24.3611
2020's	2 (12.50)	2.80

Authors	Studies
Sznajder, KK	1
Teti, DM	1
Kjerulff, KH	1
Fan, X	1
Zhang, K	1
Wang, X	1
Zhang, X	1
Zeng, L	1
Li, N	1
Han, Q	1
Liu, Z	1
Jin, J	1
Blytt, KM	1
Bjorvatn, B	1
Husebo, B	1
Flo, E	1
van de Glind, EM	2
Hooft, L	2
Tulner, LR	2
Tulen, JH	2
Kuper, IM	2
Hamburger, HL	2
de Rooij, SE	2
van Munster, BC	2
Alsaadi, SM	1
McAuley, JH	1
Hush, JM	1
Lo, S	1
Lin, CW	1
Williams, CM	1
Maher, CG	1
Te Water, W	1
Kain, ZN	1
Mayes, LC	1
Caldwell-Andrews, AA	1
Karas, DE	1
McClain, BC	1
Wegman, AC	1
van der Windt, DA	1
Stalman, WA	1
de Vries, TP	1
Mizoguchi, H	1
Wilson, A	1
Jerdack, GR	1
Hull, JD	1
Goodale, M	1
Grender, JM	1
Tyler, BA	1
Scagni, P	1
Pagliero, R	1
Hamers, JP	1
Abu-Saad, HH	1
Landis, CA	1
Robinson, CR	1
Helms, C	1
Levine, JD	1
Seward, MH	1
Vittadini, G	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Examination of Palonosetron and Hydroxyzine Pre-treatment as a Possible Method to Reduce the Objective Signs of Experimentally-induced Acute Opioid Withdrawal in Humans: a Double-blind, Randomized, Placebo-controlled Crossover Study[NCT00661674]		10 participants (Actual)	Interventional	2008-04-30	Completed
Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients[NCT01836614]	Phase 1/Phase 2	0 participants (Actual)	Interventional	2015-01-31	Withdrawn (stopped due to Study was closed due to recommendations of performing a PK study first.)
Personalizing Perioperative Morphine Analgesia for Adolescents Undergoing Major Spine Surgeries[NCT01839461]		137 participants (Actual)	Observational	2009-07-31	Completed
Longitudinal Virtual Reality Use in Pediatric Surgical Procedures[NCT03832478]		0 participants (Actual)	Interventional	2019-01-01	Withdrawn (stopped due to Technical difficulty with sending device home with patients)
Does Anxiety in Children on the Day of Surgery Impact Compliance in the Ophthalmology Clinic?[NCT02704442]		82 participants (Anticipated)	Observational	2016-02-29	Recruiting
Developing and Testing the Effectiveness of Intelligent Customer-driven Solution for Pediatric Surgery Care on the Improvement of Outcomes of Parents and Their Children Undergoing Circumcision[NCT04174404]		160 participants (Anticipated)	Interventional	2019-11-01	Recruiting
Use of Handheld Audiovisual Devices to Treat Pediatric Preoperative Anxiety: A Randomized Control Trial.[NCT02286674]		200 participants (Actual)	Interventional	2014-11-30	Completed
A Randomized Controlled Trial to Compare Pain Medications in Children Undergoing Strabismus Surgery[NCT02789969]		128 participants (Anticipated)	Interventional	2016-04-30	Recruiting
The Effect of Pre Surgery Dog Visits on Post Surgery Consumption of Pain Medication[NCT00452738]		0 participants (Actual)	Interventional	2007-04-30	Withdrawn (stopped due to PI left university. Did not start study)
ROPIVACAINE WITH CLONIDINE FOR PEDIATRIC RECTUS SHEATH BLOCKS- THE MAGIC COMBINATION? - A Double Blinded Prospective Study[NCT02439281]		50 participants (Actual)	Interventional	2015-05-31	Terminated (stopped due to The patients were discharged on the day of the surgery.)
Genetic, Epigenetic, Psychosocial, and Biological Determinants of Post-surgical Pain After Pectus or Spine Surgery[NCT04031716]		600 participants (Anticipated)	Interventional	2018-07-06	Enrolling by invitation
Adaptive Care in the Perioperative Setting: An Observational Study[NCT03353129]		60 participants (Actual)	Observational	2017-08-15	Completed
A Pilot Study to Evaluate the Efficacy of Virtual Reality on Pre-Operative Anxiety and Induction of Anesthesia in a Children's Hospital[NCT03239743]		80 participants (Anticipated)	Interventional	2017-07-20	Recruiting
Intelligent Customer-driven Solution for Children and Their Parents Undergoing Children´s Day Surgery[NCT04277299]		40 participants (Actual)	Interventional	2020-08-12	Completed
Efficacy of an Educational Pop-Up Book in Preparing Children for Anesthesia: A Randomized Controlled Trial[NCT04796077]		148 participants (Actual)	Interventional	2020-08-26	Completed
The Effects of Operating Room Virtual Tour on Preoperative Anxiety, Emergence Delirium and Postoperative Behavioral Changes of Pediatric Patients: Prospective, Randomized, and Controlled Trial[NCT03172182]		86 participants (Actual)	Interventional	2017-08-01	Completed
Non-Interventional Pharmacogenetic Study of Patient / Proxy Controlled Analgesia in Children Undergoing Surgery[NCT01731873]		182 participants (Actual)	Observational	2012-01-17	Completed
Phase III Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold[NCT02735070]	Phase 3	366 participants (Anticipated)	Interventional	2016-09-30	Not yet recruiting
Predicting Perioperative Opioid Adverse Effects and Personalizing Analgesia in Children: A Multicenter Pharmacogenetic Study[NCT01495611]		1,000 participants (Actual)	Observational	2010-11-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"The OOWS is a 13-item instrument documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. Maximum score possible = 13, minimum score possible = 0. T=15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session.~OOWS scores at T=180 is the primary outcome measure of the study compared with baseline OOWS scores at T=-30 (30 minutes prior to study medication administration). Reported time frames are in relation to time past since administration of study medications.~Mean post-Naloxone OOWS scores (+/- SEM) were determined for pretreatment groups" (NCT00661674)
Timeframe: Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration)

SOWS Score

Intervention	units on a scale (OOWS Scale) (Mean)
Placebo	3.5
Palonosetron	1.0
Palonosetron + Hydroxyzine	0

"The SOWS score is composed of 16 subjective symptoms rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. 15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session.~The highest score possible (64) would indicate that the individual was experiencing every symptom of opioid withdrawal to the fullest extent possible while the lowest score (0) would indicate that the individual was not experiencing any symptoms of opioid withdrawal.~Mean post-naloxone SOWS scores (+/- SEM) were computed for pretreatment groups: Placebo, palonosetron, and palonosetron with hydroxyzine" (NCT00661674)
Timeframe: Change from baseline in SOWS score at 180 minutes (15 minutes post naloxone administration)

Average Pain Severity at the Umbilicus Laparoscopic Site

Intervention	units on a scale (SOWS Scale) (Mean)
Placebo	6.0
Palonosetron	4.0
Palonosetron + Hydroxyzine	3.5

Numeric Rating Pain Scores ( 0-10), will be obtained every 2 hours after PACU discharge up to 18 hours or until hospital discharge, whichever occurs first. The pain score of 0, means no pain, is a good outcome , and a pain score of 10 is excruciating pain, a very bad outcome. The average of these scores will be evaluated.The pain scores will not longer be documented after the numbness went away. (NCT02439281)
Timeframe: Logistic regression of the 4 th pain score assessment

Change in Anxiety Scores

Intervention	units on a scale (Median)
Ropivacaine Group	2
Ropivacaine/ Clonidine Group	1.5

The investigators hypothesize that patient postoperative anxiety scores are lower in the Ropivacaine/Clonidine group and postoperative anxiety scores decrease more in Ropivacaine /Clonidine Group, than in Ropivacaine Group. (NCT02439281)
Timeframe: 6 hours after block placement

Complications Rate

Intervention	units on a scale (Median)
Ropivacaine Group	30
Ropivacaine/ Clonidine Group	29

The investigators expect no difference in incidence of complications (e.g. oversedation, hypotension, bradycardia episodes, etc.). (NCT02439281)
Timeframe: until study completion

Duration of Analgesia at Umbilicus Instrument Site-How Many Minutes Passed From the Time When the Blocks Where Performed Until Patient Reported Pain at Umbilicus

Intervention	Participants (Count of Participants)
Ropivacaine/ Clonidine Group	1
Ropivacaine Group	1

The investigators hypothesize that rectus sheath injections with ropivacaine/ clonidine would result in longer duration of analgesia and decreased pain scores compared to ropivacaine alone. (NCT02439281)
Timeframe: indicated by the first request for pain medication at umbilicus site

Duration of Sensory Block (Paresthesia)

Intervention	minutes (Median)
Ropivacaine/ Clonidine Group	230
Ropivacaine Group	240

The investigators hypothesize that rectus sheath injections with ropivacaine and clonidine result in longer duration of sensory block (paresthesia) compared to ropivacaine alone. (NCT02439281)
Timeframe: Indicated by return of normal sensation (expected average of 12 hours after block placement).

Medication Consumption

Intervention	minutes (Median)
Ropivacaine/ Clonidine Group	823.5
Ropivacaine Group	540

Total intravenous morphine equivalents mg/kg (NCT02439281)
Timeframe: 18 hours after surgery

Satisfaction With Pain Control From Patient

Intervention	mg/kg (Median)
Ropivacaine/ Clonidine Group	0.20
Ropivacaine Group	0.22

The investigators hypothesize that rectus sheath injections with ropivacaine/ clonidine would result in better satisfaction with pain control. (NCT02439281)
Timeframe: Prior to hospital discharge (up to 24 hours after surgery)

Article	Year
Effects of pain treatment on sleep in nursing home patients with dementia and depression: A multicenter placebo-controlled randomized clinical trial. International journal of geriatric psychiatry, 2018, Volume: 33, Issue:4 Topics: Acetaminophen; Adult; Aged; Analgesics; Buprenorphine; Dementia; Depressive Disorder; Double-Blind M	2018
Acetaminophen for self-reported sleep problems in an elderly population (ASLEEP): study protocol of a randomized placebo-controlled double-blind trial. Trials, 2014, Jan-07, Volume: 15 Topics: Acetaminophen; Age Factors; Aged; Clinical Protocols; Double-Blind Method; Humans; Hypnotics and Sed	2014
Acetaminophen for self-reported sleep problems in an elderly population (ASLEEP): a randomized double-blind placebo-controlled trial. International journal of geriatric psychiatry, 2016, Volume: 31, Issue:8 Topics: Acetaminophen; Aged; Aged, 80 and over; Analgesics, Non-Narcotic; Double-Blind Method; Female; Human	2016
Efficacy of a single evening dose of syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate in subjects with multiple common cold symptoms. International journal of clinical pharmacology and therapeutics, 2007, Volume: 45, Issue:4 Topics: Acetaminophen; Adolescent; Adult; Analgesics, Non-Narcotic; Antitussive Agents; Bronchodilator Agent	2007
[Use in the pediatric field of an antipyretic, hypno-sedative and analgesic combination]. Minerva pediatrica, 1973, Feb-11, Volume: 25, Issue:4 Topics: Acetaminophen; Analgesics; Benzoates; Child, Preschool; Clinical Trials as Topic; Drug Combinations;	1973

acetaminophen and Long Sleeper Syndrome