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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Sterile water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 4-8 years Scheduled VCUG at Sick Kids Understand the consent and assent form in English Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Fentanyl<br>* 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.<br>|
| Placebo Comparator: 2<br> | Drug: Sterile water<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain before and after catheterization for the VCUG. |  | Will be measured up until 30 mins after the VCUG procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Pain, Voiding Cystourethrogram, Catheterization, Fentanyl