Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405444
Status:
COMPLETED
Last Update Posted:
2010-12-13
First Post:
2006-11-28
Brief Title:
Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children
Status:
COMPLETED
Status Verified Date:
2010-12
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 determine whether intranasal fentanyl is better than placebo at decreasing pain in children 4-8 years of age during urinary catheterization for a VCUG study
Detailed Description:
Studies have shown that the voiding cystourethrogram VCUG can be distressful and painful for children as the child is catheterized during the procedure Currently no sedation or analgesia is recommended for the procedure The practice of pediatrics is constantly seeking measures to decrease pain and distress for children The opioid fentanyl was originally synthesized in the 1950s and 60s as an alternative to morphine and meperidine The safety and efficacy of intranasal IN fentanyl has been previously demonstrated in the setting of a pediatric emergency department
We are proposing the use of IN fentanyl for analgesia prior to the catheterization for a voiding cystourethrogram VCUG If we prove that IN fentanyl is effective in reducing the pain while ensuring patient safety it could become the analgesic of choice for this procedure
We are proposing the use of IN fentanyl for analgesia prior to the catheterization for a voiding cystourethrogram VCUG If we prove that IN fentanyl is effective in reducing the pain while ensuring patient safety it could become the analgesic of choice for this procedure
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