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 Drug: Sterile water	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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. [ Time Frame: Will be measured up until 30 mins after the VCUG procedure. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Heart rate, respiratory rate and oxygen saturation just prior to and after the administration of fentanyl. [ Time Frame: Every 5 minutes until 30 minutes after the VCUG procedure. ] [ Designated as safety issue: No ]
Nausea, vomiting, itching, nasal pain/irritation or any other side effects. [ Time Frame: Will be measured up until 30 mins after the VCUG procedure. ] [ Designated as safety issue: Yes ]
Length of stay in diagnostic suite [ Time Frame: Time frame determined by outcome ] [ Designated as safety issue: No ]

Enrollment:	64
Study Start Date:	November 2006
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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.
Placebo Comparator: 2	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.

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

Locations

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator:

Seen Chung, MD

The Hospital for Sick Children, Toronto Canada

More Information

Publications:

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. Epub 2010 Feb 24.

Responsible Party:	Seen Chung/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00405444 History of Changes
Other Study ID Numbers:	1000009018
Study First Received:	November 28, 2006
Last Updated:	December 10, 2010
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

Pediatrics
Pain
Voiding Cystourethrogram
Catheterization
Fentanyl

Additional relevant MeSH terms:

Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012