Ignite Creation Date:
2024-05-05 @ 10:18 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01071057
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2010-02-17
Brief Title:
Naloxone for the Treatment of Opioid-Induced Pruritus
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Naloxone for the Treatment of Opioid-Induced Pruritus A Double-Blind Prospective Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2017-10
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:
The purpose of this study is to improve how we treat itching a common side effect associated with the use of morphine pain medication Itching is a problem experienced by up to 30 of the children treated with pain medications in the morphine family
Despite studies demonstrating the effectiveness of using naloxone to treat itchiness in adults receiving morphine pain medications there are not many studies in children This study is designed to study how well naloxone works for treatment of itching in children
Despite studies demonstrating the effectiveness of using naloxone to treat itchiness in adults receiving morphine pain medications there are not many studies in children This study is designed to study how well naloxone works for treatment of itching in children
Detailed Description:
Hypothesis Naloxone co-administered simultaneously with standard Patient Controlled Analgesia PCA basal and bolus morphine will significantly reduce the incidence of Opioid Induced Pruritus OIP without affecting analgesia or opioid consumption in children
Specific Objectives
1 To determine if naloxone 12 µgml mixed in a single infusion with morphine 1 mgml will be effective in the prevention of opioid induced pruritus OIP
2 To determine if treatment with naloxone will result in attenuation of analgesia or an increase in opioid utilisation
3 To determine if treatment with naloxone will reduce other opioid induced side effects such as nausea and vomiting
Methods This study is divided into two phases Phase 1 - Although there are studies confirming the compatibility of morphine 4 mgmL with naloxone 16 µgmL in separate infusion pumps run into the same intravenous site there are no studies confirming the chemical and physical compatibility of morphine and naloxone in the same syringe with the standard concentrations used at BCCH Therefore a compatibility and stability study of naloxone and morphine solution in the same syringe will be performed
Phase 2 - Phase 2 is a blinded clinical trial where 70 subjects will be randomized to receive either morphine mixed with naloxone or morphine mixed with placeboWith institutional review board approval and written parentalguardian informed consent and assent if appropriate we will recruit children ages 5-16 years receiving intravenous opioids via PCA for post-operative pain control Subjects will be evaluated every 4 hr for pain scores frequency of vomiting nausea pruritus sedation and respiratory depression At 24 and 48 hr the total morphine consumption will be calculated
Data analysis Differences in the incidence and intensity of pruritus between the two groups will be compared We will review side effects using the following control variables 1 demographic data and 2 summation of opioid use in each 4 hr period for total opioid consumption ANOVA and crosstabs will be used where appropriate to analyze data
Specific Objectives
1 To determine if naloxone 12 µgml mixed in a single infusion with morphine 1 mgml will be effective in the prevention of opioid induced pruritus OIP
2 To determine if treatment with naloxone will result in attenuation of analgesia or an increase in opioid utilisation
3 To determine if treatment with naloxone will reduce other opioid induced side effects such as nausea and vomiting
Methods This study is divided into two phases Phase 1 - Although there are studies confirming the compatibility of morphine 4 mgmL with naloxone 16 µgmL in separate infusion pumps run into the same intravenous site there are no studies confirming the chemical and physical compatibility of morphine and naloxone in the same syringe with the standard concentrations used at BCCH Therefore a compatibility and stability study of naloxone and morphine solution in the same syringe will be performed
Phase 2 - Phase 2 is a blinded clinical trial where 70 subjects will be randomized to receive either morphine mixed with naloxone or morphine mixed with placeboWith institutional review board approval and written parentalguardian informed consent and assent if appropriate we will recruit children ages 5-16 years receiving intravenous opioids via PCA for post-operative pain control Subjects will be evaluated every 4 hr for pain scores frequency of vomiting nausea pruritus sedation and respiratory depression At 24 and 48 hr the total morphine consumption will be calculated
Data analysis Differences in the incidence and intensity of pruritus between the two groups will be compared We will review side effects using the following control variables 1 demographic data and 2 summation of opioid use in each 4 hr period for total opioid consumption ANOVA and crosstabs will be used where appropriate to analyze data
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