Trial Outcomes & Findings for A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery (NCT NCT01451762)

Last Updated: 2014-03-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

90 participants

Primary outcome timeframe

24 hours post operatively

Results posted on

2014-03-14

Participant Flow

90 subjects were enrolled between September 2011 and September 2012.

Participant milestones

Participant milestones
Measure	Placebo .9 normal saline IV	25 mg Diphenhydramine IV 25 mg diphenhydramine IV administered before surgery	50 mg Diphenhydramine IV 50 mg diphenhydramine IV administered before surgery
Overall Study STARTED	30	30	30
Overall Study COMPLETED	27	24	24
Overall Study NOT COMPLETED	3	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo .9 normal saline IV	25 mg Diphenhydramine IV 25 mg diphenhydramine IV administered before surgery	50 mg Diphenhydramine IV 50 mg diphenhydramine IV administered before surgery
Overall Study Lost to Follow-up	3	6	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=30 Participants .9 normal saline IV	25 mg Diphenhydramine IV n=30 Participants 25 mg diphenhydramine IV administered before surgery	50 mg Diphenhydramine IV n=30 Participants 50 mg diphenhydramine IV administered before surgery	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	30 Participants n=5 Participants	90 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	35 years STANDARD_DEVIATION 8.36 • n=5 Participants	36.5 years STANDARD_DEVIATION 10.7 • n=7 Participants	37 years STANDARD_DEVIATION 8.3 • n=5 Participants	37 years STANDARD_DEVIATION 9.1 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	30 Participants n=5 Participants	90 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	30 participants n=5 Participants	90 participants n=4 Participants

PRIMARY outcome

Timeframe: 24 hours post operatively

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants .9 normal saline IV	25 mg Diphenhydramine IV n=24 Participants 25 mg diphenhydramine IV administered before surgery	50 mg Diphenhydramine IV n=24 Participants 50 mg diphenhydramine IV administered before surgery
Quality of Recovery 40 at 24 Hours	164 units on scale 40 (low) - 200 (high) Interval 151.0 to 189.0	169 units on scale 40 (low) - 200 (high) Interval 159.0 to 181.0	172 units on scale 40 (low) - 200 (high) Interval 157.0 to 185.0

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

25 mg Diphenhydramine IV

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

50 mg Diphenhydramine IV

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=27 participants at risk .9 normal saline IV	25 mg Diphenhydramine IV n=24 participants at risk 25 mg diphenhydramine IV administered before surgery	50 mg Diphenhydramine IV n=24 participants at risk 50 mg diphenhydramine IV administered before surgery
Gastrointestinal disorders Nausea	44.4% 12/27 • Number of events 12 • 24 hours	37.5% 9/24 • Number of events 9 • 24 hours	12.5% 3/24 • Number of events 3 • 24 hours

Additional Information

Gildasio De Oliveira MD

Northwestern University

Phone: 312-472-3573

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place