Compounds > diphenhydramine
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diphenhydramine and Acute Post-operative Pain

diphenhydramine has been researched along with Acute Post-operative Pain in 18 studies

Diphenhydramine: A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.
diphenhydramine : An ether that is the benzhydryl ether of 2-(dimethylamino)ethanol. It is a H1-receptor antagonist used as a antipruritic and antitussive drug.
antitussive : An agent that suppresses cough. Antitussives have a central or a peripheral action on the cough reflex, or a combination of both. Compare with expectorants, which are considered to increase the volume of secretions in the respiratory tract, so facilitating their removal by ciliary action and coughing, and mucolytics, which decrease the viscosity of mucus, facilitating its removal by ciliary action and expectoration.

Research Excerpts

ExcerptRelevanceReference
"Ondansetron is as effective as diphenhydramine in relieving pruritus caused by SA morphine in patients undergoing a cesarean delivery."9.14Ondansetron is as effective as diphenhydramine for treatment of morphine-induced pruritus after cesarean delivery. ( Adham, AM; Aouad, MT; Dagher, CM; Saasouh, WA; Siddik-Sayyid, SM; Yazbeck-Karam, VG; Zahreddine, BW, 2010)
"We examined the efficacy of epidural butorphanol to either prevent or relieve pruritus associated with epidural morphine infusion in children."9.09Continuous epidural butorphanol relieves pruritus associated with epidural morphine infusions in children. ( Gregg, T; Gunter, JB; McAuliffe, J; Sweeney, DM; Varughese, AM; Weidner, N, 2000)
"PONV was assessed in recovery and 24 hours after surgery in the ward."7.01Prophylactic Administration of Diphenhydramine/Acetaminophen and Ondansetron Reduced Postoperative Nausea and Vomiting and Pain Following Laparoscopic Sleeve Gastrectomy: a Randomized Controlled Trial. ( Aghabagheri, M; Khajavi, MR; Najjari, K; Pourfakhr, P; Talebpour, M; Zabihi Mahmoudabadi, H, 2021)
"Ondansetron is as effective as diphenhydramine in relieving pruritus caused by SA morphine in patients undergoing a cesarean delivery."5.14Ondansetron is as effective as diphenhydramine for treatment of morphine-induced pruritus after cesarean delivery. ( Adham, AM; Aouad, MT; Dagher, CM; Saasouh, WA; Siddik-Sayyid, SM; Yazbeck-Karam, VG; Zahreddine, BW, 2010)
"the objective of this study was to assess whether antiemetic drugs metoclopramide and diphenhydramine, administered together as opposed to alone, can have better efficacy in preventing postoperative nausea and vomiting when added to patient-controlled morphine analgesia."5.14Antiemetic efficacy of metoclopramide and diphenhydramine added to patient-controlled morphine analgesia: a randomised controlled trial. ( Jean, WH; Lin, TY; Lu, CW; Shieh, JS; Wu, CC, 2010)
"We examined the efficacy of epidural butorphanol to either prevent or relieve pruritus associated with epidural morphine infusion in children."5.09Continuous epidural butorphanol relieves pruritus associated with epidural morphine infusions in children. ( Gregg, T; Gunter, JB; McAuliffe, J; Sweeney, DM; Varughese, AM; Weidner, N, 2000)
"PONV was assessed in recovery and 24 hours after surgery in the ward."3.01Prophylactic Administration of Diphenhydramine/Acetaminophen and Ondansetron Reduced Postoperative Nausea and Vomiting and Pain Following Laparoscopic Sleeve Gastrectomy: a Randomized Controlled Trial. ( Aghabagheri, M; Khajavi, MR; Najjari, K; Pourfakhr, P; Talebpour, M; Zabihi Mahmoudabadi, H, 2021)
"Diphenhydramine treatment also reduced the severity of CRBD at 6 h postoperatively (p = 0."2.94Prophylactic diphenhydramine attenuates postoperative catheter-related bladder discomfort in patients undergoing gynecologic laparoscopic surgery: a randomized double-blind clinical study. ( Chen, JY; Chu, CC; Feng, PH; Hsing, CH; Li, YY; Wang, JJ; Wang, KF; Wu, WJ; Zeng, YS, 2020)
"Diphenhydramine is an antihistamine with previously demonstrated analgesic and antiemetic properties."2.82Dose-ranging effect of systemic diphenhydramine on postoperative quality of recovery after ambulatory laparoscopic surgery: a randomized, placebo-controlled, double-blinded, clinical trial. ( Bialek, J; De Oliveira, GS; Marcus, RJ; McCarthy, R, 2016)
"The incidence of postoperative nausea (31."2.71Antiemetic and analgesic-sparing effects of diphenhydramine added to morphine intravenous patient-controlled analgesia. ( Lin, CJ; Lin, TF; Sun, WZ; Wang, YP; Yeh, YC; Yen, YH, 2005)
"In both groups, postoperative pain appeared to increase from 3 to 7 h and decrease from 7 to 24 h."2.67Local prophylactic benadryl injections in an attempt to reduce postinstrumental pain. ( Berman, D; Feldman, MJ; Nevins, A; Verhelle, R, 1994)

Research

Studies (18)

TimeframeStudies, this research(%)All Research%
pre-19906 (33.33)18.7374
1990's2 (11.11)18.2507
2000's2 (11.11)29.6817
2010's5 (27.78)24.3611
2020's3 (16.67)2.80

Authors

AuthorsStudies
Li, YY1
Zeng, YS1
Chen, JY1
Wang, KF1
Hsing, CH1
Wu, WJ1
Wang, JJ1
Feng, PH1
Chu, CC1
Khajavi, MR2
Saffarian, A1
Majidi, F1
Moharari, RS1
Pourfakhr, P2
Parhiz, SA1
Aghabagheri, M1
Zabihi Mahmoudabadi, H1
Najjari, K1
Talebpour, M1
Bina, B1
Hersh, EV1
Hilario, M1
Alvarez, K1
McLaughlin, B1
Cooper, S1
Laurora, I1
Wang, Y1
Venkataraman, P1
An, R1
Roth, T1
De Oliveira, GS1
Bialek, J1
Marcus, RJ1
McCarthy, R1
Siddik-Sayyid, SM1
Yazbeck-Karam, VG1
Zahreddine, BW1
Adham, AM1
Dagher, CM1
Saasouh, WA1
Aouad, MT1
Lu, CW1
Jean, WH1
Wu, CC1
Shieh, JS1
Lin, TY1
SABA, GM1
OPPO, GT1
Lin, TF1
Yeh, YC1
Yen, YH1
Wang, YP1
Lin, CJ1
Sun, WZ1
Albal, MV1
Chandorkar, AG1
Esperov, BN1
Zimin, AM1
Nevins, A2
Verhelle, R1
Feldman, MJ1
Berman, D1
Gunter, JB1
McAuliffe, J1
Gregg, T1
Weidner, N1
Varughese, AM1
Sweeney, DM1
Shelestiuk, GS1
Pakhal'chuk, MS1
Borisko, AS1
Hoefflin, SM1
Friedman, L1
DeVita, R1
Schacter, W1
Shanin, SS1
Shtanov, SA1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain With Phase Advanced Sleep[NCT01280591]Phase 3712 participants (Actual)Interventional2010-10-31Completed
A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy and Safety of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain With Phase Advanced Sleep[NCT01495858]Phase 3267 participants (Actual)Interventional2011-12-31Completed
A Prospective Evaluation of an Anesthesia Protocol to Reduce Post-operative and Post-discharge Nausea and Vomiting in a High Risk Orthognathic Surgery Population[NCT01592708]233 participants (Actual)Interventional2012-06-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in Pain Intensity

Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain (NCT01280591)
Timeframe: Baseline and up to 10 hours

InterventionScores on a scale (Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)-1.2
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)-0.7
Naproxen Sodium 440 mg (BAYH6689)-0.9
DPH 50 mg0.1

Sleep Efficiency Measured by Actigraphy

Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01280591)
Timeframe: Up to 10 hours

InterventionPercent of sleep time during in-bed time (Least Squares Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)71.0
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)56.3
Naproxen Sodium 440 mg (BAYH6689)59.3
DPH 50 mg23.6

Sleep Latency Measured by Actigraphy

Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01280591)
Timeframe: Up to 10 hours

InterventionMinutes (Median)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)25.50
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)30.25
Naproxen Sodium 440 mg (BAYH6689)25.75
DPH 50 mg41.50

Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed

Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes) (NCT01280591)
Timeframe: Up to 10 hours

InterventionMinutes (Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)73.8
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)75.3
Naproxen Sodium 440 mg (BAYH6689)103.5
DPH 50 mg81.7

Subjective Sleep Questionnaire - Quality of Your Sleep Last Night

Subjects responded to Quality of sleep (10-point scale, where 1 was poor and 10 was excellent) (NCT01280591)
Timeframe: Up to 10 hours

InterventionScores on a scale (Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)6.4
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)5.9
Naproxen Sodium 440 mg (BAYH6689)5.4
DPH 50 mg4.9

Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night

Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing) (NCT01280591)
Timeframe: Up to 10 hours

InterventionScores on a scale (Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)6.2
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)5.8
Naproxen Sodium 440 mg (BAYH6689)5.5
DPH 50 mg4.4

Subjective Sleep Questionnaire - Time to Fall Asleep Last Night

Subjects responded to Estimate of how long it took to fall asleep (minutes) (NCT01280591)
Timeframe: Up to 10 hours

InterventionMinutes (Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)40.0
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)40.7
Naproxen Sodium 440 mg (BAYH6689)53.4
DPH 50 mg42.4

Time to Rescue Medication

If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded (NCT01280591)
Timeframe: Up to 10 hours

InterventionMinutes (Median)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)NA
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)NA
Naproxen Sodium 440 mg (BAYH6689)NA
DPH 50 mg113.5

Total Sleep Time Measured by Actigraphy

Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01280591)
Timeframe: Up to 10 hours

InterventionMinutes (Least Squares Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)426.2
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)337.7
Naproxen Sodium 440 mg (BAYH6689)355.8
DPH 50 mg141.4

Wake Time After Sleep Onset (WASO) Measured by Actigraphy

WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01280591)
Timeframe: Up to 10 hours

InterventionMinutes (Least Squares Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)143.7
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)230.9
Naproxen Sodium 440 mg (BAYH6689)214.0
DPH 50 mg431.4

Cumulative Proportion of Subjects Taking Rescue Medication by Hour

If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded (NCT01280591)
Timeframe: Up to 10 hours

,,,
Interventionparticipants (Number)
≤ 60 minutes≤ 120 minutes≤ 180 minutes≤ 240 minutes≤ 300 minutes≤ 360 minutes≤ 420 minutes≤ 480 minutes≤ 540 minutes≤ 600 minutes
DPH 50 mg0536670747677787878
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)1365057656978838789
Naproxen Sodium 440 mg (BAYH6689)0274147505562636768
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)0182325293436394243

Global Assessment of Investigational Product as a Pain Reliever

The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4). (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
0 = Poor1 = Fair2 = Good3 = Very good4 = Excellent
DPH 50 mg45970
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)216354825
Naproxen Sodium 440 mg (BAYH6689)015365634
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)29436448

Global Assessment of Investigational Product as a Sleep Aid

The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4). (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
0 = Poor1 = Fair2 = Good3 = Very good4 = Excellent
DPH 50 mg39670
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)1029472613
Naproxen Sodium 440 mg (BAYH6689)295137177
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)839584912

Karolinska Sleep Diary - Calmness of Sleep

Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = Very restless2 = Rather restless3 = Neither restless nor calm4 = Rather calm5 = Very calm
DPH 50 mg51610123
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)829396826
Naproxen Sodium 440 mg (BAYH6689)748426122
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)835377632

Karolinska Sleep Diary - Ease of Awakening

Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = Very difficult2 = Rather difficult3 = Neither difficult nor easy4 = Rather easy5 = Very easy
DPH 50 mg01101520
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)04249448
Naproxen Sodium 440 mg (BAYH6689)12338856
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)07289855

Karolinska Sleep Diary - Easiness to Fall Asleep

Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = Very difficult2 = Rather difficult3 = Neither difficult nor easy4 = Rather easy5 = Very easy
DPH 50 mg8161093
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)1145574215
Naproxen Sodium 440 mg (BAYH6689)1259554113
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)841576220

Karolinska Sleep Diary - Premature Awakening

Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = Woke up much too early2 = Woke up somewhat too early3 = No
DPH 50 mg23176
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)545957
Naproxen Sodium 440 mg (BAYH6689)658035
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)407771

Karolinska Sleep Diary - Sleep Quality

Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = Very poor2 = Rather poor3 = Neither poor nor good4 = Rather good5 = Very good
DPH 50 mg31013182
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)524526821
Naproxen Sodium 440 mg (BAYH6689)539695512
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)323468234

Karolinska Sleep Diary - Sufficient Sleep

Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = No, definitely too little2 = No, much too little3 = No, somewhat too little4 = Yes, almost enough5 = Yes, definitely enough
DPH 50 mg1081495
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)2124405233
Naproxen Sodium 440 mg (BAYH6689)1822565826
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)714378446

Karolinska Sleep Diary - Well Rested

Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = Not rested at all2 = Somewhat unrested3 = Completely rested
DPH 50 mg8317
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)219554
Naproxen Sodium 440 mg (BAYH6689)1611648
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)910079

Overall Rating of Pain Relief

"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)." (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
0 = No relief1 = A little relief2 = Some relief3 = A lot of relief4 = Complete relief
DPH 50 mg7911183
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)894295329
Naproxen Sodium 440 mg (BAYH6689)688246240
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)444326558

Change From Baseline in Pain Intensity

Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain (NCT01495858)
Timeframe: Baseline and up to 10 hours

InterventionScores on a scale (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)2.4
Naproxen Sodium 440 mg (BAYH6689)2.4
DPH 50 mg2.5

Sleep Efficiency Measured by Actigraphy

Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01495858)
Timeframe: Up to 10 hours

InterventionPercent of sleep time during in-bed time (Least Squares Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)69.777
Naproxen Sodium 440 mg (BAYH6689)65.396
DPH 50 mg34.436

Sleep Latency Measured by Actigraphy

Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01495858)
Timeframe: Up to 10 hours

InterventionMinutes (Median)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)23.50
Naproxen Sodium 440 mg (BAYH6689)16.75
DPH 50 mg27.50

Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed

Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes) (NCT01495858)
Timeframe: Up to 10 hours

InterventionMinutes (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)111.1
Naproxen Sodium 440 mg (BAYH6689)144.8
DPH 50 mg98.4

Subjective Sleep Questionnaire - Quality of Your Sleep Last Night

Subject evaluated sleep quality on a 10-point scale, where 1 was poor and 10 was excellent. (NCT01495858)
Timeframe: Up to 10 hours

InterventionScores on a scale (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)6.5
Naproxen Sodium 440 mg (BAYH6689)5.8
DPH 50 mg4.9

Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night

Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing) (NCT01495858)
Timeframe: Up to 10 hours

InterventionScores on a scale (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)6.6
Naproxen Sodium 440 mg (BAYH6689)5.7
DPH 50 mg4.6

Subjective Sleep Questionnaire - Time to Fall Asleep Last Night

Subjects responded to Estimate of how long it took to fall asleep (minutes) (NCT01495858)
Timeframe: Up to 10 hours

InterventionMinutes (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)39.5
Naproxen Sodium 440 mg (BAYH6689)40.2
DPH 50 mg40.0

Time to Rescue Medication

If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded (NCT01495858)
Timeframe: Up to 10 hours

InterventionMinutes (Median)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)NA
Naproxen Sodium 440 mg (BAYH6689)NA
DPH 50 mg146.50

Total Sleep Time Measured by Actigraphy

Total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01495858)
Timeframe: Up to 10 hours

InterventionMinutes (Least Squares Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)418.66
Naproxen Sodium 440 mg (BAYH6689)392.38
DPH 50 mg206.61

Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure at Day 2

(NCT01495858)
Timeframe: Baseline and Day 2

InterventionmmHg (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)0.7
Naproxen Sodium 440 mg (BAYH6689)-0.2
DPH 50 mg2.1

Vital Signs: Mean Change From Baseline in Pulse Rate at Day 2

(NCT01495858)
Timeframe: Baseline and day 2

InterventionBeats/min (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)1.0
Naproxen Sodium 440 mg (BAYH6689)-0.1
DPH 50 mg4.7

Vital Signs: Mean Change From Baseline in Respiratory Rate at Day 2

(NCT01495858)
Timeframe: Baseline and day 2

InterventionBreaths/min (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)-1.4
Naproxen Sodium 440 mg (BAYH6689)-1.2
DPH 50 mg-0.3

Vital Signs: Mean Change From Baseline in Systolic Blood Pressure at Day 2

(NCT01495858)
Timeframe: Baseline and day 2

InterventionmmHg (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)-1.3
Naproxen Sodium 440 mg (BAYH6689)-0.6
DPH 50 mg2.2

Wake Time After Sleep Onset (WASO) Measured by Actigraphy

WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01495858)
Timeframe: Up to 10 hours

InterventionMinutes (Least Squares Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)155.25
Naproxen Sodium 440 mg (BAYH6689)180.08
DPH 50 mg364.83

Cumulative Proportion of Participants Taking Rescue Medication by Hour

If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded (NCT01495858)
Timeframe: Up to 10 hours

,,
Interventionparticipants (Number)
≤ 60 minutes≤ 120 minutes≤ 180 minutes≤ 240 minutes≤ 300 minutes≤ 360 minutes≤ 420 minutes≤ 480 minutes≤ 540 minutes≤ 600 minutes
DPH 50 mg0212932333435353535
Naproxen Sodium 440 mg (BAYH6689)1121317232526283030
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)091415161721222424

Global Assessment of Investigational Product as a Pain Reliever

The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4). (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
0 = Poor1 = Fair2 = Good3 = Very good4 = Excellent
DPH 50 mg15391
Naproxen Sodium 440 mg (BAYH6689)13253812
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)14224018

Global Assessment of Investigational Product as a Sleep Aid

The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4). (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
0 = Poor1 = Fair2 = Good3 = Very good4 = Excellent
DPH 50 mg17281
Naproxen Sodium 440 mg (BAYH6689)132424135
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)212372311

Karolinska Sleep Diary - Calmness of Sleep

Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = Very restless2 = Rather restless3 = Neither restless nor calm4 = Rather calm5 = Very calm
DPH 50 mg5175134
Naproxen Sodium 440 mg (BAYH6689)32924424
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)12618489

Karolinska Sleep Diary - Ease of Awakening

Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = Very difficult2 = Rather difficult3 = Neither difficult nor easy4 = Rather easy5 = Very easy
DPH 50 mg0251423
Naproxen Sodium 440 mg (BAYH6689)30165330
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)01175628

Karolinska Sleep Diary - Easiness to Fall Asleep

Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = Very difficult2 = Rather difficult3 = Neither difficult nor easy4 = Rather easy5 = Very easy
DPH 50 mg9614123
Naproxen Sodium 440 mg (BAYH6689)833272311
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)329223612

Karolinska Sleep Diary - Premature Awakening

Subjects responded to the following question : Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = Woke up much too early2 = Woke up somewhat too early3 = No
DPH 50 mg211112
Naproxen Sodium 440 mg (BAYH6689)315219
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)244533

Karolinska Sleep Diary - Sleep Quality

Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = Very poor2 = Rather poor3 = Neither poor nor good4 = Rather good5 = Very good
DPH 50 mg9119123
Naproxen Sodium 440 mg (BAYH6689)322313610
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)11233479

Karolinska Sleep Diary - Sufficient Sleep

Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = No, definitely too little2 = No, much too little3 = No, somewhat too little4 = Yes, almost enough5 = Yes, definitely enough
DPH 50 mg1368116
Naproxen Sodium 440 mg (BAYH6689)1010273421
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)28185222

Karolinska Sleep Diary - Well Rested

Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = Not rested at all2 = Somewhat unrested3 = Completely rested
DPH 50 mg131714
Naproxen Sodium 440 mg (BAYH6689)95538
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)75342

Overall Rating of Pain Relief

"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)." (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
0 = No relief1 = A little relief2 = Some relief3 = A lot of relief4 = Complete relief
DPH 50 mg354582
Naproxen Sodium 440 mg (BAYH6689)303153721
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)245104721

Hospital Length of Stay

Anesthesia start time determined from anesthesia portion of the medical record. Time at which discharge order was placed will serve as time of discharge. (NCT01592708)
Timeframe: Anesthesia start time to placement of hospital discharge order - average 26 - 28 hours

Interventionhours (Median)
Intervention Cohort26.4
Comparison Cohort28.2

Post-discharge Nausea

To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital (NCT01592708)
Timeframe: 1 week from discharge from hospital

Interventionpercentage of subjects with PDN (Number)
Intervention Cohort72
Comparison Cohort60

Post-discharge Vomiting

(NCT01592708)
Timeframe: 1 week post discharge

Interventionpercentage of subjects with PDV (Number)
Intervention Cohort22
Comparison Cohort29

Post-operative Nausea

End of surgery time determined by anesthesia portion of the medical record. PONV to be assessed by review of surgeons' and nurses' notes in the medical record as well as through review of patient diaries. Vomiting constitutes a safety issue and, as such, associated adverse events will be noted. (NCT01592708)
Timeframe: End of surgery to discharge from hospital

Interventionpercentage of subjects with PON (Number)
Intervention Cohort24
Comparison Cohort70

Post-operative Vomiting

(NCT01592708)
Timeframe: End of surgery to discharge from hospital

Interventionpercentage of subjects with POV (Number)
Intervention Cohort11
Comparison Cohort28

Reviews

1 review available for diphenhydramine and Acute Post-operative Pain

ArticleYear
True Allergy to Amide Local Anesthetics: A Review and Case Presentation.
    Anesthesia progress, 2018,Summer, Volume: 65, Issue:2

    Topics: Adult; Anesthesia, Dental; Anesthetics, Local; Contraindications, Drug; Diphenhydramine; Drug Hypers

2018

Trials

10 trials available for diphenhydramine and Acute Post-operative Pain

ArticleYear
Prophylactic diphenhydramine attenuates postoperative catheter-related bladder discomfort in patients undergoing gynecologic laparoscopic surgery: a randomized double-blind clinical study.
    Journal of anesthesia, 2020, Volume: 34, Issue:2

    Topics: Adult; Diphenhydramine; Double-Blind Method; Female; Humans; Laparoscopy; Pain, Postoperative; Urina

2020
Prophylactic administration of diphenhydramine/paracetamol reduced emergence agitation and postoperative pain following maxillofacial surgeries: a randomized controlled trial.
    European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2022, Volume: 279, Issue:3

    Topics: Acetaminophen; Adult; Anesthesia Recovery Period; Anesthesia, General; Dexmedetomidine; Diphenhydram

2022
Prophylactic Administration of Diphenhydramine/Acetaminophen and Ondansetron Reduced Postoperative Nausea and Vomiting and Pain Following Laparoscopic Sleeve Gastrectomy: a Randomized Controlled Trial.
    Obesity surgery, 2021, Volume: 31, Issue:10

    Topics: Acetaminophen; Antiemetics; Diphenhydramine; Double-Blind Method; Gastrectomy; Humans; Laparoscopy;

2021
Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia.
    International journal of clinical practice, 2015, Volume: 69, Issue:10

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Diphenhydramine; Dose-Response Relationship, Drug; Double-B

2015
Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia.
    International journal of clinical practice, 2015, Volume: 69, Issue:10

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Diphenhydramine; Dose-Response Relationship, Drug; Double-B

2015
Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia.
    International journal of clinical practice, 2015, Volume: 69, Issue:10

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Diphenhydramine; Dose-Response Relationship, Drug; Double-B

2015
Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia.
    International journal of clinical practice, 2015, Volume: 69, Issue:10

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Diphenhydramine; Dose-Response Relationship, Drug; Double-B

2015
Dose-ranging effect of systemic diphenhydramine on postoperative quality of recovery after ambulatory laparoscopic surgery: a randomized, placebo-controlled, double-blinded, clinical trial.
    Journal of clinical anesthesia, 2016, Volume: 34

    Topics: Administration, Intravenous; Adult; Ambulatory Surgical Procedures; Analgesics, Opioid; Antiemetics;

2016
Ondansetron is as effective as diphenhydramine for treatment of morphine-induced pruritus after cesarean delivery.
    Acta anaesthesiologica Scandinavica, 2010, Volume: 54, Issue:6

    Topics: Adult; Cesarean Section; Diphenhydramine; Double-Blind Method; Female; Histamine H1 Antagonists; Hum

2010
Antiemetic efficacy of metoclopramide and diphenhydramine added to patient-controlled morphine analgesia: a randomised controlled trial.
    European journal of anaesthesiology, 2010, Volume: 27, Issue:12

    Topics: Adult; Analgesia, Patient-Controlled; Analgesics, Opioid; Antiemetics; Dexamethasone; Diphenhydramin

2010
Antiemetic and analgesic-sparing effects of diphenhydramine added to morphine intravenous patient-controlled analgesia.
    British journal of anaesthesia, 2005, Volume: 94, Issue:6

    Topics: Adult; Aged; Analgesia, Patient-Controlled; Analgesics, Opioid; Antiemetics; Diphenhydramine; Double

2005
Local prophylactic benadryl injections in an attempt to reduce postinstrumental pain.
    Journal of endodontics, 1994, Volume: 20, Issue:6

    Topics: Adult; Anesthetics, Local; Diphenhydramine; Double-Blind Method; Humans; Pain Measurement; Pain, Pos

1994
Continuous epidural butorphanol relieves pruritus associated with epidural morphine infusions in children.
    Paediatric anaesthesia, 2000, Volume: 10, Issue:2

    Topics: Adolescent; Analgesia, Epidural; Analgesics, Opioid; Anesthetics, Local; Antipruritics; Bupivacaine;

2000

Other Studies

7 other studies available for diphenhydramine and Acute Post-operative Pain

ArticleYear
[Clinical tests of a new analgesic combination in therapy of postoperative pain in gynecological surgery].
    Minerva ginecologica, 1958, Apr-30, Volume: 10, Issue:8

    Topics: Analgesics; Analgesics, Non-Narcotic; Antipyretics; Diphenhydramine; Female; Genitalia; Genitalia, F

1958
Clinical evaluation of Sedyn-A-forte, an analgesic injection containing analgin, diphenhydramine and diazepam.
    Indian journal of ophthalmology, 1982, Volume: 30, Issue:4

    Topics: Aminopyrine; Analgesics; Diazepam; Diphenhydramine; Dipyrone; Drug Combinations; Humans; Ophthalmolo

1982
[Long-term epidural anesthesia in the postoperative period].
    Khirurgiia, 1981, Issue:8

    Topics: Abdomen, Acute; Adolescent; Adult; Anesthesia, Epidural; Diphenhydramine; Droperidol; Female; Humans

1981
[Use of neruoleptoanalgesia in the postoperative period].
    Vestnik khirurgii imeni I. I. Grekova, 1976, Volume: 117, Issue:11

    Topics: Adolescent; Adult; Aged; Child; Child, Preschool; Diphenhydramine; Droperidol; Drug Combinations; Fe

1976
Decreasing prolonged swelling and pain associated with deep plane face lifts.
    Plastic and reconstructive surgery, 1992, Volume: 90, Issue:6

    Topics: Bupivacaine; Dexamethasone; Diphenhydramine; Edema; Humans; Pain, Postoperative; Postoperative Compl

1992
Local injection of Benadryl for the prevention of iatrogenic endodontic flare-ups.
    Endodontics & dental traumatology, 1988, Volume: 4, Issue:2

    Topics: Diphenhydramine; Double-Blind Method; Humans; Iatrogenic Disease; Pain, Postoperative; Pilot Project

1988
[Electroanalgesia after operations on the abdominal organs].
    Vestnik khirurgii imeni I. I. Grekova, 1987, Volume: 139, Issue:8

    Topics: Analgesics; Cholecystitis; Diphenhydramine; Dipyrone; Electric Stimulation Therapy; Hemodynamics; Hu

1987