Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323154
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2006-05-08
Brief Title:
Nalbuphine for the Treatment of Opioid Induced Pruritus in Children
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Nalbuphine for the Treatment of Opioid Induced Pruritus in Children
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
PURPOSE Primary To determine the efficacy of nalbuphine 50 - 100 mcgkg 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 Childrens 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
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 Childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| W02-0175 | None | None | None |