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

The Hospital for Sick Children64 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain

Interventions

FentanylDRUG

The dose of fentanyl that each child will receive will be 2 mcg/kg based on the child's weight. The medication will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds.

Sterile waterDRUG

The dose of sterile water that each child will receive will be 2 mcg/kg based on the child's weight. It will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 8 Years

Medical Language ↔ Plain English

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 (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Change in pain before and after catheterization for the VCUG.

Time frame: Will be measured up until 30 mins after the VCUG procedure.

Secondary Outcomes

Heart rate, respiratory rate and oxygen saturation just prior to and after the administration of fentanyl.

Time frame: Every 5 minutes until 30 minutes after the VCUG procedure.

Nausea, vomiting, itching, nasal pain/irritation or any other side effects.

Time frame: Will be measured up until 30 mins after the VCUG procedure.

Length of stay in diagnostic suite

Time frame: Time frame determined by outcome

Data from ClinicalTrials.gov

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