At a glance
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Celecoxib for Pain Management After Tonsillectomy
In Brief
A Phase 2 clinical trial evaluating Celecoxib, Placebo, and 2 other interventions for Tonsillectomy. Completed, enrolled 172 participants across 1 site.
Detailed Summary
Tonsillectomy is one of the most common pediatric surgical procedures in the United States. Postoperative pain is substantial, with typical regimens employing narcotic derivatives and acetaminophen for 1-2 weeks after surgery. Recent enthusiasm for use of ibuprofen as an alternative has been tempered by equivocal data on its relative safety in regard to risk of postoperative hemorrhage. The primary objective is to evaluate efficacy of celecoxib for pain control after tonsillectomy in children. The secondary objective is to assess safety in regard to postoperative hemorrhage and adverse events.
Study Details
Timeline
Interventions
Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally
Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day.
Acetaminophen syrup at a dose of 15mg/kg/dose will be given every 4 hours for the first 5 days after surgery. After that point, is given as needed.
Oxycodone may be used every 4 hours post-operatively to treat breakthrough pain. The most commonly prescribed dose is 0.075mg/kg/dose (suspension) every 4 hours as needed.