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

NCT00405444 | Completed Phase 3 DMC

• 1 other identifier: 1000009018
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pediatrics; Pain; Voiding Cystourethrogram; Catheterization; Fentanyl

Outcome Measures

Primary Outcomes (1)

• Change in pain before and after catheterization for the VCUG.

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

Secondary Outcomes (3)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: Fentanyl

2

PLACEBO COMPARATOR

Drug: Sterile water

Interventions

Fentanyl DRUG

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.

1

Sterile water DRUG

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.

2

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 4-8 years
• Scheduled VCUG at Sick Kids
• Understand the consent and assent form in English

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related 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.

  PMID: 20180109 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Seen Chung, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 30, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 13, 2010

Record last verified: 2010-12

Locations

CA (1)