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NCT01451762 · ClinicalTrials.gov registry record · NA
A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
NCT01451762: Completed NA study, sponsored by Northwestern University.
NCT01451762 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 90 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01451762, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
Study Summary
Pain after ambulatory surgery remains an unsolved problem in The United States and Europe. It is associated with delayed hospital discharge and it can result to an increased opioid consumption with adverse side effects. The concept of multimodal analgesic technique was introduced more than 15 years ago and several techniques have been studied over the years including non steroidal antiinflammatory drugs (NSAIDs), acetaminophen, gabapentoids, ketamine, local and regional anesthetic techniques. Histamine can have effects on polymodal nociceptors and C-fibers, producing pain which is further increased by neurogenically mediated release of substance P from afferent pain fibers. Several non-selective or H1 -selective histamine receptors antagonists have been demonstrated in animal models and clinical pain. Chia et al demonstrated that preoperative promethazine had opioid sparing properties without adverse sedative effects in patients undergoing abdominal hysterectomy. Diphenhydramine is an anti-histamine drug who has been found to be effective in reducing postoperative nausea and vomiting after ambulatory surgery but its effects on postoperative pain and other important outcomes after ambulatory surgery such as time to meet discharge criteria have not being studied. The MQOR 40 is a validated instrument that was specifically design to evaluate patient recovery after anesthesia and surgery. This instrument can be particularly valid to examine interventions which affect different spheres of patient recovery as is the case of diphenhydramine. The objective of this study is to determine a dose response effect of preoperative diphenhydramine on postoperative quality of recovery after ambulatory surgery. The use of preoperative diphenhydramine can improve patient's quality of recovery, decrease postoperative pain, opioid consumption and opioid related side effects after ambulatory surgery. The research question: Does a preoperative dose of diphenhydramine improve postoperat
Primary Outcome
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.
Interventions
- DRUG .9 normal saline
- DRUG 25 mg diphenhydramine IV
- DRUG 50 mg diphenhydramine IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-09 |
| Phase | NA |
What the finished NCT01451762 record still lists
NCT01451762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which .9 normal saline is the first listed.
NCT01451762 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01451762 about?
NCT01451762 is a clinical study titled "A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery". Pain after ambulatory surgery remains an unsolved problem in The United States and Europe. It is associated with delayed hospital discharge and it can result to an increased opioid consumption with adverse side effects. The concept of multimodal analgesic technique was introduced more than 15 years ...
What is the current status of trial NCT01451762?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2011-09. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01451762?
The interventions under investigation include: .9 normal saline (DRUG), 25 mg diphenhydramine IV (DRUG), 50 mg diphenhydramine IV (DRUG).
Who is sponsoring clinical trial NCT01451762?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01451762's enrollment target sits among peer trials
90 941st of 2000 higher than 1,029 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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