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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405444
• Other study ID #: 1000009018
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2006
• Last updated: December 10, 2010
• Start date: November 2006
• Est. completion date: September 2008

Study information

• Verified date: December 2010
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 8 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Fentanyl
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 water
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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain before and after catheterization for the VCUG.		Will be measured up until 30 mins after the VCUG procedure.	No
Secondary	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.	No
Secondary	Nausea, vomiting, itching, nasal pain/irritation or any other side effects.		Will be measured up until 30 mins after the VCUG procedure.	Yes
Secondary	Length of stay in diagnostic suite		Time frame determined by outcome	No