Pain Clinical Trial
Official title:
Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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