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

NCT ID: NCT00405444

Last Updated: 2010-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-09-30

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.

Conditions

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Pain

Keywords

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Pediatrics Pain Voiding Cystourethrogram Catheterization Fentanyl

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Fentanyl

Intervention Type 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.

2

Group Type PLACEBO_COMPARATOR

Sterile water

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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The Hospital for Sick Children

Principal Investigators

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Seen Chung, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 20180109 (View on PubMed)

Other Identifiers

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1000009018

Identifier Type: -

Identifier Source: org_study_id