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Trial record 11 of 448 for:    diphenhydramine

A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery

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ClinicalTrials.gov Identifier: NCT01451762
Recruitment Status : Completed
First Posted : October 14, 2011
Results First Posted : March 14, 2014
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Surgery
Pain
Interventions Drug: .9 normal saline
Drug: 25 mg diphenhydramine IV
Drug: 50 mg diphenhydramine IV
Enrollment 90
Recruitment Details 90 subjects were enrolled between September 2011 and September 2012.
Pre-assignment Details  
Arm/Group Title Placebo 25 mg Diphenhydramine IV 50 mg Diphenhydramine IV
Hide Arm/Group Description .9 normal saline IV 25 mg diphenhydramine IV administered before surgery 50 mg diphenhydramine IV administered before surgery
Period Title: Overall Study
Started 30 30 30
Completed 27 24 24
Not Completed 3 6 6
Reason Not Completed
Lost to Follow-up             3             6             6
Arm/Group Title Placebo 25 mg Diphenhydramine IV 50 mg Diphenhydramine IV Total
Hide Arm/Group Description .9 normal saline IV 25 mg diphenhydramine IV administered before surgery 50 mg diphenhydramine IV administered before surgery Total of all reporting groups
Overall Number of Baseline Participants 30 30 30 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 90 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
30
 100.0%
30
 100.0%
90
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 30 participants 90 participants
35  (8.36) 36.5  (10.7) 37  (8.3) 37  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 90 participants
Female
30
 100.0%
30
 100.0%
30
 100.0%
90
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 30 participants 90 participants
30 30 30 90
1.Primary Outcome
Title Quality of Recovery 40 at 24 Hours
Hide Description Scores on QOR (quality of recovery) 40 questionnaire.The QoR-40 score, which ranges from 40 to 200, representing very poor to outstanding quality of recovery, respectively.
Time Frame 24 hours post operatively
Hide Outcome Measure Data
Hide Analysis Population Description
Primary outcome was QOR 40 a sample size of 23 per group was estimated to achieve 80% power to detect a 10 point difference in aggregated QOR040 score for the three groups. A 10 point difference represents a clinically relevant improvement in quality of recovery. TO account for drop outs lost to follow up 90 subjects were randomized.
Arm/Group Title Placebo 25 mg Diphenhydramine IV 50 mg Diphenhydramine IV
Hide Arm/Group Description:
.9 normal saline IV
25 mg diphenhydramine IV administered before surgery
50 mg diphenhydramine IV administered before surgery
Overall Number of Participants Analyzed 27 24 24
Median (Inter-Quartile Range)
Unit of Measure: units on scale 40 (low) - 200 (high)
164
(151 to 189)
169
(159 to 181)
172
(157 to 185)
Time Frame 24 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 25 mg Diphenhydramine IV 50 mg Diphenhydramine IV
Hide Arm/Group Description .9 normal saline IV 25 mg diphenhydramine IV administered before surgery 50 mg diphenhydramine IV administered before surgery
All-Cause Mortality
Placebo 25 mg Diphenhydramine IV 50 mg Diphenhydramine IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo 25 mg Diphenhydramine IV 50 mg Diphenhydramine IV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/24 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 25 mg Diphenhydramine IV 50 mg Diphenhydramine IV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/27 (44.44%)      9/24 (37.50%)      3/24 (12.50%)    
Gastrointestinal disorders       
Nausea * 1  12/27 (44.44%)  12 9/24 (37.50%)  9 3/24 (12.50%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
We did not obtain preoperative quality of recovery scores of patients therefore we could not examine whether the effect of diphenhydramine was dependent upon patient's baseline characteristics.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gildasio De Oliveira MD
Organization: Northwestern University
Phone: 312-472-3573
Responsible Party: Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier: NCT01451762     History of Changes
Other Study ID Numbers: STU00044695
First Submitted: September 20, 2011
First Posted: October 14, 2011
Results First Submitted: October 28, 2013
Results First Posted: March 14, 2014
Last Update Posted: March 14, 2014