Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children
Information source: The Hospital for Sick Children
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Fentanyl (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s):
Ran Goldman, MD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto Canada
Overall contact:
Ran Goldman, MD, Phone: 416-813-4915, Email: ran.goldman@sickkids.ca
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.
Clinical Details
Official title: Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Change in pain before and after catheterization for the VCUG
Secondary outcome: Heart rate, respiratory rate and oxygen saturation just prior to and after the administration of fentanyl;Nausea, vomiting, itching, nasal pain/irritation or any other side effects; Length of stay in diagnostic suite
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.
Eligibility
Minimum age: 4 Years.
Maximum age: 8 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Ran Goldman, MD, Phone: 416-813-4915, Email: ran.goldman@sickkids.ca
The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting
Ran Goldman, MD, Phone: 416 813 4915, Email: ran.goldman@sickkids.ca
Ran Goldman, MD, Principal Investigator
Seen Chung, MD, Sub-Investigator
Ruth Lim, MD, Sub-Investigator
Additional Information
Starting date: November 2006
Ending date: November 2007
Last updated: November 28, 2006
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