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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 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 90 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01451762
The ClinicalTrials.gov registry entry for NCT01451762 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which .9 normal saline is the first listed.
NCT01451762 reports 0 study locations.
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.
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