Pruritis Clinical Trial
Official title:
Nalbuphine for the Treatment of Opioid Induced Pruritus in Children
Verified date | September 2008 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 134 |
Est. completion date | December 2004 |
Est. primary completion date | December 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 7 Years |
Eligibility |
Inclusion Criteria: - Postoperative morphine administration |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | British Columbia's Children's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pruritis intensity | Unspecified | No | |
Secondary | Pain, sedation | Unspecified | No |
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