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

February 14, 2014 updated by: Gildasio De Oliveira, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Prentice Womens Hospital
      • Chicago, Illinois, United States, 60611
        • Prentice Womens HOsptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery 40 at 24 Hours
Time Frame: 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.
24 hours post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

October 11, 2011

First Posted (Estimate)

October 14, 2011

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

February 14, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00044695

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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