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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00405444
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : December 13, 2010
Sponsor:
Information provided by:
The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Fentanyl Drug: Sterile water Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children
Study Start Date : November 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in pain before and after catheterization for the VCUG. [ Time Frame: Will be measured up until 30 mins after the VCUG procedure. ]

Secondary Outcome Measures :
  1. 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. ]
  2. Nausea, vomiting, itching, nasal pain/irritation or any other side effects. [ Time Frame: Will be measured up until 30 mins after the VCUG procedure. ]
  3. Length of stay in diagnostic suite [ Time Frame: Time frame determined by outcome ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405444


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Seen Chung, MD The Hospital for Sick Children, Toronto Canada
Publications:
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Responsible Party: Seen Chung/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00405444    
Other Study ID Numbers: 1000009018
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: December 13, 2010
Last Verified: December 2010
Keywords provided by The Hospital for Sick Children:
Pediatrics
Pain
Voiding Cystourethrogram
Catheterization
Fentanyl
Additional relevant MeSH terms:
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Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics