Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children - Full Text View

Sponsor:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00405444

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Fentanyl	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting Urine and Urination

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

Change in pain before and after catheterization for the VCUG

Secondary Outcome Measures:

Heart rate, respiratory rate and oxygen saturation just prior to and after the administration of fentanyl;
Nausea, vomiting, itching, nasal pain/irritation or any other side effects;
Length of stay in diagnostic suite

Estimated Enrollment:	64
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2007

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

Ages Eligible for Study:	4 Years to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405444

Contacts

Contact: Ran Goldman, MD

416-813-4915

ran.goldman@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Ran Goldman, MD 416 813 4915 ran.goldman@sickkids.ca
Principal Investigator: Ran Goldman, MD
Sub-Investigator: Seen Chung, MD
Sub-Investigator: Ruth Lim, MD

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator:

Ran Goldman, MD

The Hospital for Sick Children, Toronto Canada

More Information

No publications provided

Study ID Numbers:	1000009018
Study First Received:	November 28, 2006
Last Updated:	November 28, 2006
ClinicalTrials.gov Identifier:	NCT00405444 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

Pediatrics
Pain
Voiding Cystourethrogram
Catheterization
Fentanyl

Additional relevant MeSH terms:

Anesthetics, Intravenous
Fentanyl
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010