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NOT YET RECRUITING
NCT07870447
PHASE1/PHASE2

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

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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

Interventions

DRUG

Celecoxib

Oral celecoxib 6 mg/kg per dose (max 100 mg), given the evening before surgery and the morning of surgery

DRUG

Acetaminophen

Intra-operative acetaminophen (Tylenol)

DRUG

Dexamethasone

Intra-operative dexamethasone (Decadron)

Locations (1)

NYU Langone Health

New York, New York, United States