Trial · NCT01451762
A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery
NCT01451762, Not applicable, Completed, Northwestern University; results first posted 2014-03-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery. Trials, record NCT01451762. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01451762
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery
- NCT number
- NCT01451762
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 90 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Surgery, Pain
- Interventions
- .9 normal saline, 25 mg diphenhydramine IV, 50 mg diphenhydramine IV
- First posted
- 2011-10-14
- Last updated
- 2014-03-14
- Results first posted
- 2014-03-14
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Quality of Recovery 40 at 24 Hours | 24 hours post operatively | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Quality of Recovery 40 at 24 Hours | 24 hours post operatively | 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. | units on scale 40 (low) - 200 (high) | MEDIAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Quality of Recovery 40 at 24 Hours | Placebo | 164 | Inter-Quartile Range 151 to 189 | units on scale 40 (low) - 200 (high) | |
| Quality of Recovery 40 at 24 Hours | 25 mg Diphenhydramine IV | 169 | Inter-Quartile Range 159 to 181 | units on scale 40 (low) - 200 (high) | |
| Quality of Recovery 40 at 24 Hours | 50 mg Diphenhydramine IV | 172 | Inter-Quartile Range 157 to 185 | units on scale 40 (low) - 200 (high) |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | STARTED | 25 mg Diphenhydramine IV | 30 | |
| Overall Study | STARTED | 50 mg Diphenhydramine IV | 30 | |
| Overall Study | COMPLETED | Placebo | 27 | |
| Overall Study | COMPLETED | 25 mg Diphenhydramine IV | 24 | |
| Overall Study | COMPLETED | 50 mg Diphenhydramine IV | 24 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | 25 mg Diphenhydramine IV | 6 | |
| Overall Study | NOT COMPLETED | 50 mg Diphenhydramine IV | 6 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 12 | 27 | 12 |
| other | Nausea | Gastrointestinal disorders | 25 mg Diphenhydramine IV | 9 | 24 | 9 |
| other | Nausea | Gastrointestinal disorders | 50 mg Diphenhydramine IV | 3 | 24 | 3 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | 25 mg Diphenhydramine IV | ||
| Total, all-cause mortality | 50 mg Diphenhydramine IV | ||
| Total, other adverse events | Placebo | 12 | 27 |
| Total, other adverse events | 25 mg Diphenhydramine IV | 9 | 24 |
| Total, other adverse events | 50 mg Diphenhydramine IV | 3 | 24 |
| Total, serious adverse events | Placebo | 0 | 27 |
| Total, serious adverse events | 25 mg Diphenhydramine IV | 0 | 24 |
| Total, serious adverse events | 50 mg Diphenhydramine IV | 0 | 24 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01451762
GET https://conductscience.org/api/trials/v1/NCT01451762/registered