Clinical trial NCT00405444: Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children
Official title: Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Pediatrics
Pain
Voiding Cystourethrogram
Catheterization
Fentanyl
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2006-11-30
Enrollment: 64
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Change in pain before and after catheterization for the VCUG.
timeFrame: Will be measured up until 30 mins after the VCUG procedure.
Secondary outcomes:
measure: Heart rate, respiratory rate and oxygen saturation just prior to and after the administration of fentanyl.
timeFrame: Every 5 minutes until 30 minutes after the VCUG procedure.
measure: Nausea, vomiting, itching, nasal pain/irritation or any other side effects.
timeFrame: Will be measured up until 30 mins after the VCUG procedure.
measure: Length of stay in diagnostic suite
timeFrame: Time frame determined by outcome
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Seen Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.