Preoperative Celecoxib and Acetaminophen Versus Acetaminophen Alone for Pain Control After Pediatric Adenotonsillectomy

StatusNot Yet Recruiting
PhasePhase 1/2
Started

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Record History

  1. Minor Study First Submitted
This is an open-label randomized study of approximately 500 pediatric patients (2-18 years of age, weighing more than 10 kg) undergoing adenotonsillectomy. Participants are assigned to a preoperative multimodal analgesic regimen (oral celecoxib the evening before and the morning of surgery, plus intra-operative dexamethasone and acetaminophen) or to standard of care (no pre-operative medication; intra-operative dexamethasone and acetaminophen). The primary aim is to compare postoperative pain control, measured by rescue analgesic consumption, over the first 72 hours after surgery. Secondary aims assess safety (postoperative bleeding and adverse medication events) and feasibility (healthcare utilization and caregiver satisfaction).
Trial Details
NCT Number NCT07870447
Lead Sponsor NYU Langone Health
Conditions
(from sponsor)
Adenotonsillectomy, Postoperative Pain
Related terms Postoperative Pain
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov