Nalbuphine for the Treatment of Opioid Induced Pruritus in Children
Information source: University of British Columbia
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pruritis
Intervention: Nalbuphine (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
Carolyne Montgomery, MD, Principal Investigator, Affiliation: The University of British Columbia
Summary
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.
Clinical Details
Official title: Nalbuphine for the Treatment of Opioid Induced Pruritus in Children
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Pruritis intensity
Secondary outcome: Pain, sedation
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.
Eligibility
Minimum age: N/A.
Maximum age: 7 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Postoperative morphine administration
Exclusion Criteria:
-
Locations and Contacts
British Columbia’s Children’s Hospital, Vancouver, British Columbia, Canada
Additional Information
Starting date: March 2004
Ending date: December 2004
Last updated: May 8, 2006
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