Nalbuphine for the Treatment of Opioid Induced Pruritus in Children

06:44 EDT 31st October 2014 | 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

Clinical Trials [7 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 ...

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.

Comparative Study of the Efficacy of SARNA Sensitive Lotion for Treatment of Uremic Itch in Adult Hemodialysis Patients

The purpose of this research study is to evaluate the efficacy of SARNA Sensitive Lotion in the treatment of uremic pruritus in adult hemodialysis patients in a double-blind Controlled com...

PubMed Articles [9 Associated PubMed Articles listed on BioPortfolio]

Morphine versus Nalbuphine for Open Gynaecological Surgery: A Randomized Controlled Double Blinded Trial.

Introduction. Pain is the commonest morbidity after open surgical procedures. The most effective treatment of postoperative pain is opioid therapy. Morphine, the commonly used opioid, is associated wi...

Impact of efficacy at the mu opioid receptor on antinociceptive effects of combinations of mu opioid receptor agonists and cannabinoid receptor agonists.

Cannabinoid receptor agonists [e.g. Δ9-tetrahydrocannabinol (Δ9-THC)] enhance the antinociceptive effects of mu opioid receptor agonists, suggesting that combining cannabinoids with opioids would im...

Therapeutic management of sarcoptic mange in a sheep flock.

Sarcoptic mange infested sheep showed pruritis, excoriation, crusts, lichenification and secondary alopecia on face and ears. All the infested sheep were treated successfully with Ivermectin at 200 ...

The Effect of Desonide Hydrogel on Pruritis Associated With Atopic Dermatitis.

Itch is a common and troubling symptom of atopic dermatitis. It is not mediated by histamine, and standard anti-itch therapies, therefore, have limited benefit for most AD patients. Instead, anti-infl...

Pyrazinamide-induced exfoliative dermatitis in a patient on hemodialysis: a rare complication.

A 60-year-old male patient on maintenance hemodialysis was started on antituberculosis therapy with isoniazid, rifampin, ethambutol, and pyrazinamide for pulmonary tuberculosis. After 4 weeks of thera...

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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