drugset / Trial / NCT02934191

Celecoxib After Tonsillectomy

NCT02934191

Phase 2 Completed 172 enrolled Children's Hospital of Philadelphia Pfizer · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2016-06
Primary completion
2018-08-17
Completion
2019-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Celecoxib Other / unclassified 6 mg/kg Oral
Background Acetaminophen Small molecule 15 mg/kg Oral
Background Oxycodone Other / unclassified 0.075 mg/kg

Indications