A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 postoperative quality of recovery after ambulatory surgery? The hypothesis of this study is that preoperative diphenhydramine will improve postoperative pain, Postoperative nausea and vomiting (PONV), sleep which will translate in a better overall quality of recovery.
| Condition | Intervention |
|---|---|
|
Surgery Pain |
Drug: .9 normal saline Drug: 25 mg diphenhydramine IV Drug: 50 mg diphenhydramine IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery |
- Quality of Recovery 40 at 24 hours [ Time Frame: 24 hours post operatively ] [ Designated as safety issue: No ]The use of preoperative diphenhydramine will decrease postoperative pain by blocking histamine induced hyperalgesia and provide a better quality of recovery to patients after ambulatory surgery.
| Enrollment: | 85 |
| Study Start Date: | September 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
.9 normal saline IV
|
Drug: .9 normal saline
.9 normal saline administered before surgery.
|
|
Active Comparator: 25 mg diphenhydramine IV
25 mg diphenhydramine IV administered before surgery
|
Drug: 25 mg diphenhydramine IV
25 mg diphenhydramine IV administered before surgery
|
|
Active Comparator: 50 mg diphenhydramine IV
50 mg diphenhydramine IV administered before surgery
|
Drug: 50 mg diphenhydramine IV
50 mg diphenhydramine administered IV before surgery
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-64 years
- Patients undergoing ambulatory surgery
- ASA PS I, II.
Exclusion Criteria:
- Chronic opioid use
- pregnant patient or lactating patients
- allergy to diphenhydramine
- glaucoma
- uncontrolled hypertension
- asthma
- hyperthyroidism
- cardiovascular disease
Contacts and Locations| United States, Illinois | |
| Prentice Womens HOspital | |
| Chicago, Illinois, United States, 60611 | |
| Prentice Womens HOsptial | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Gildasio De Oliveira, MD | Northwestern University |
More Information
Publications:
| Responsible Party: | Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01451762 History of Changes |
| Other Study ID Numbers: | STU00044695 |
| Study First Received: | September 20, 2011 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
pain anesthesia surgery postoperative |
Additional relevant MeSH terms:
|
Diphenhydramine Promethazine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Histamine H1 Antagonists Histamine Antagonists |
Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hypnotics and Sedatives Central Nervous System Depressants Anti-Allergic Agents Anesthetics, Local Anesthetics Sensory System Agents Antipruritics Dermatologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013