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

Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Surgery; Pain

Intervention: .9 normal saline (Drug); 25 mg diphenhydramine IV (Drug); 50 mg diphenhydramine IV (Drug)

Phase: N/A

Status: Completed

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Gildasio De Oliveira, MD, Principal Investigator, Affiliation: Northwestern University


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Quality of Recovery 40 at 24 Hours


Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Female.


Inclusion Criteria:

- Age 18-64 years

- Patients undergoing ambulatory surgery


Exclusion Criteria:

- Chronic opioid use

- pregnant patient or lactating patients

- allergy to diphenhydramine

- glaucoma

- uncontrolled hypertension

- asthma

- hyperthyroidism

- cardiovascular disease

Locations and Contacts

Prentice Womens HOspital, Chicago, Illinois 60611, United States

Prentice Womens HOsptial, Chicago, Illinois 60611, United States

Additional Information

Related publications:

Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-40, table of contents.

Benhamou D, Berti M, Brodner G, De Andres J, Draisci G, Moreno-Azcoita M, Neugebauer EA, Schwenk W, Torres LM, Viel E. Postoperative Analgesic THerapy Observational Survey (PATHOS): a practice pattern study in 7 central/southern European countries. Pain. 2008 May;136(1-2):134-41. Epub 2007 Aug 20.

Kehlet H, Dahl JB. The value of "multimodal" or "balanced analgesia" in postoperative pain treatment. Anesth Analg. 1993 Nov;77(5):1048-56. Review.

White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. Review.

Schmelz M, Schmidt R, Bickel A, Handwerker HO, Torebjörk HE. Specific C-receptors for itch in human skin. J Neurosci. 1997 Oct 15;17(20):8003-8.

Baird-Lambert J, Jamieson DD. Possible mediators of the writhing response induced by acetic acid or phenylbenzoquinone in mice. Clin Exp Pharmacol Physiol. 1983 Jan-Feb;10(1):15-20.

Rumore MM, Schlichting DA. Analgesic effects of antihistaminics. Life Sci. 1985 Feb 4;36(5):403-16. Review.

Raffa RB. Antihistamines as analgesics. J Clin Pharm Ther. 2001 Apr;26(2):81-5. Review.

Starting date: September 2011
Last updated: February 14, 2014

Page last updated: August 23, 2015

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