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

The Hospital for Sick Children

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Fentanyl; Drug: Sterile water

Study type: Interventional

Funder types: Other

Identifiers

NCT00405444

1000009018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Fentanyl

2

Placebo Comparator group

Treatment:

Drug: Sterile water