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

Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Fentanyl (Drug); Sterile water (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: The Hospital for Sick Children

Official(s) and/or principal investigator(s):
Seen Chung, MD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto Canada

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada
Additional Information

Related publications:

Chung S, Lim R, Goldman RD. Intranasal fentanyl versus placebo for pain in children during catheterization for voiding cystourethrography. Pediatr Radiol. 2010 Jul;40(7):1236-40. doi: 10.1007/s00247-009-1521-1. Epub 2010 Feb 24.

Starting date: November 2006
Last updated: December 10, 2010

Page last updated: August 23, 2015

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