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Sponsored by: |
The Hospital for Sick Children |
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Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00405444 |
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 |
Estimated Enrollment: | 64 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2007 |
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.
Ages Eligible for Study: | 4 Years to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ran Goldman, MD | 416-813-4915 | ran.goldman@sickkids.ca |
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 |
Principal Investigator: | Ran Goldman, MD | The Hospital for Sick Children, Toronto Canada |
Study ID Numbers: | 1000009018 |
Study First Received: | November 28, 2006 |
Last Updated: | November 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00405444 |
Health Authority: | Canada: Health Canada |
Pediatrics Pain Voiding Cystourethrogram Catheterization Fentanyl |
Fentanyl Pain |
Anesthetics, Intravenous Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |