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Preoperative Celecoxib and Acetaminophen Versus Acetaminophen Alone for Pain Control After Pediatric Adenotonsillectomy
Sponsor: NYU Langone Health
Summary
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).
Official title: An Open-Label, Randomized Study of Preoperative Celecoxib After Pediatric Adenotonsillectomy
Key Details
Gender
All
Age Range
2 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2026-11-01
Completion Date
2029-12-30
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Celecoxib
Oral celecoxib 6 mg/kg per dose (max 100 mg), given the evening before surgery and the morning of surgery
Acetaminophen
Intra-operative acetaminophen (Tylenol)
Dexamethasone
Intra-operative dexamethasone (Decadron)
Locations (1)
NYU Langone Health
New York, New York, United States