Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Sterile water; Drug: Fentanyl

• Registration Number: NCT00405444
• Lead Sponsor: The Hospital for Sick Children

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 1950's and 60's 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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-28
• Study First Submitted QC: 2006-11-28
• Study First Posted: 2006-11-30
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-10
• Last Update Posted: 2010-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Age 4-8 years
2. Scheduled VCUG at Sick Kids
3. Understand the consent and assent form in English

Exclusion Criteria

1. Previous adverse events to fentanyl or any opioid
2. History of a chronic respiratory or cardiac illness
3. Children with developmental delay
4. Children with bilateral nasal congestion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Sterile water	-
1	Fentanyl	-

Primary Outcome Measures

Name	Time	Method
Change in pain before and after catheterization for the VCUG.	Will be measured up until 30 mins after the VCUG procedure.

Secondary Outcome Measures

Name	Time	Method
Heart rate, respiratory rate and oxygen saturation just prior to and after the administration of fentanyl.	Every 5 minutes until 30 minutes after the VCUG procedure.
Nausea, vomiting, itching, nasal pain/irritation or any other side effects.	Will be measured up until 30 mins after the VCUG procedure.
Length of stay in diagnostic suite	Time frame determined by outcome

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada