Status:
COMPLETED
Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Pain
Eligibility:
All Genders
4-8 years
Phase:
PHASE3
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 recomme...
Eligibility Criteria
Inclusion
- Age 4-8 years
- Scheduled VCUG at Sick Kids
- Understand the consent and assent form in English
Exclusion
- Previous adverse events to fentanyl or any opioid
- History of a chronic respiratory or cardiac illness
- Children with developmental delay
- Children with bilateral nasal congestion.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00405444
Start Date
November 1 2006
End Date
September 1 2008
Last Update
December 13 2010
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8