Nalbuphine for the Treatment of Opioid Induced Pruritus in Children

September 24, 2008 updated by: University of British Columbia

Itching is a frequent and disturbing side effect of the use of pain medication such as morphine. In the post-operative period, it can be more distressing to pediatric patients than their pain. The current first line treatment, an antihistamine (Benadryl), has a low efficacy. This treatment causes sleepiness and may be dangerous when used in combination with other drugs.

Nalbuphine has analgesic properties similar to morphine as well as the ability to reverse some morphine-induced side effects, such as respiratory depression and itching. Nalbuphine has been used effectively for patients undergoing Caesarean sections. However, the effectiveness of nalbuphine in the pediatric population has not been investigated.

We want to determine the efficacy of nalbuphine in the treatment of itching after morphine for postoperative pain relief. We will use a novel method to measure the effect of the treatment using an intensity scale before and after the drug, to determine the intensity difference.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PURPOSE Primary To determine the efficacy of nalbuphine (50 - 100 mcg/kg intravenously) in the treatment of opioid induced pruritus in a multi-center tertiary care pediatric patient population.

Secondary Determine the effect of treatment with nalbuphine on a subjects analgesia and level of sedation.

HYPOTHESIS

Primary Outcome:

Nalbuphine will be effective in the treatment of opioid induced pruritus; a 50% reduction in pruritus intensity will be considered clinically significant.

Secondary Outcome:

Treatment with nalbuphine will not result in attenuation of analgesia or an increase in sedation

JUSTIFICATION Itch is a frequent and disturbing side effect of opioid use. A recent internal review of the pediatric pain service at the University of Alberta Hospital, Edmonton, Alberta found a 40% incidence of pruritus in patients receiving opioids. A similar review at British Columbia Children's Hospital demonstrated a 22% of patients incidence of pruritus.

OBJECTIVES The compare the efficacy of nalbuphine to placebo for the treatment of opioid-induced pruritus. It is anticipated that nalbuphine will result in a greater than 50% reduction in pruritus intensity.

RESEARCH METHOD This study will be a randomized, double-blinded, placebo controlled trial of nalbuphine for the treatment of opioid-induced pruritus. Pruritus intensity will be measured using a standardized assessment tool / Color Analog Scale (CAS). This is a metric scale which will be used to quantify pruritus on a scale of zero to ten. Using this scale a score of zero is represented by white, increasing pruritus severity being represented by darker shades of the color red, along a ruler.

Data analysis will be based on intenton to treat. It will be a multi-center study involving tertiary care centers with acute pediatric pain services.

Subjects will be divided into two groups by computer generated block randomization; one group will receive treatment with nalbuphine while the other will receive placebo. The patient and investigator will be blinded to the treatment administered.

REASON FOR PLACEBO CONTROLLED STUDY DESIGN Current first line therapy for opioid induced pruritus, with diphenhydramine is associated with a low efficacy (33%) (1). Recognizing that there can be up to 30% self report response to placebo, it is felt that conducting this study as a placebo-controlled trial will be necessary for the demonstration of significant improvement in pruritus intensity.

Study Type

Interventional

Enrollment (Anticipated)

134

Phase

  • Phase 3

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • British Columbia's Children's Hospital

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

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Postoperative morphine administration

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pruritis intensity

Secondary Outcome Measures

Outcome Measure
Pain, sedation

Collaborators and Investigators

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

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Carolyne Montgomery, MD, The University of British Columbia

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

March 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria

May 8, 2006

First Posted (Estimate)

May 9, 2006

Study Record Updates

Last Update Posted (Estimate)

September 25, 2008

Last Update Submitted That Met QC Criteria

September 24, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C02-0589
  • W02-0175

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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