Nalbuphine for the Treatment of Opioid Induced Pruritus in Children

2014-08-26 22:44:50 | BioPortfolio

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.

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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Pruritis

Intervention

Nalbuphine

Location

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

Status

Completed

Source

University of British Columbia

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-26T22:44:50-0400

Clinical Trials [8 Associated Clinical Trials listed on BioPortfolio]

Interaction Between Nalbuphine and Morphine in PCA

1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist 2. This study was designed to investigate the interaction between nalbuphine and morphine

Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain

Patients with chronic masticatory muscle pain (i.e., pain greater than three months) or patients with burning mouth syndrome participate in this study. The aim of the study is to compare ...

Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodial...

Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus

Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in patient undergoing cesarean section?

Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs

The purpose of this study was to investigate a possible response to nalbuphine (Nubian) and morphine with traditional Chinese herbs in healthy volunteers.

PubMed Articles [6 Associated PubMed Articles listed on BioPortfolio]

Nalbuphine, a non-controlled opioid analgesic, and its potential use in research mice.

Nalbuphine is an inexpensive, non-controlled, opioid analgesic that has been in clinical use for decades. A kappa opioid receptor agonist and mu opioid receptor antagonist, nalbuphine causes fewer adv...

A Comparision of Nalbuphine with Morphine for Analgesic Effects and Safety : Meta-Analysis of Randomized Controlled Trials.

Although morphine is the standard opioid analgesic for pain control and has been widely used, certain drug-induced adverse effects have been reported as intolerable and need to be addressed. Nalbuphin...

Expressions of matrix metalloproteinases-1 and -9 and opioid growth factor in rabbit cornea after lamellar keratectomy and treatment with 1% nalbuphine.

To evaluate the effects of nalbuphine 1% on the expression of metalloproteinase 1 (MMP-1), metalloproteinase 9 (MMP-9), and opioid growth factor (OGF) in rabbit corneas after lamellar keratectomy.

Use of an organotypic mammalian in vitro follicle growth assay to facilitate female reproductive toxicity screening.

Screening of pharmaceutical, chemical and environmental compounds for their effects on reproductive health relies on in vivo studies. More robust and efficient methods to assess these effects are need...

Compound heterozygous mutations of ABCB11 responsible for benign recurrent intrahepatic cholestasis.

Benign recurrent intrahepatic cholestasis is a rare autosomal recessive disease characterized by repeated episodes of intense pruritis and jaundice. Mutations of ATP8B1 and ABCB11 are known to predisp...

Medical and Biotech [MESH] Definitions

A narcotic used as a pain medication. It appears to be an agonist at kappa opioid receptors and an antagonist or partial agonist at mu opioid receptors.

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