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NCT07870447
Preoperative Celecoxib and Acetaminophen Versus Acetaminophen Alone for Pain Control After Pediatric Adenotonsillectomy
Conditions: Adenotonsillectomy, Postoperative Pain
Sex: All
Ages: 2 Years – 18 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 500
Sponsor: NYU Langone Health
Location: NYU Langone Health New York New York
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).
Eligibility Criteria
Inclusion Criteria:
* Pediatric patients 2-18 years of age
* Weighing greater than 10 kg
* Undergoing adenotonsillectomy
* English- or Spanish-speaking patients
Exclusion Criteria:
* Any adjunct procedure other than bilateral myringotomy tubes (BMT) or direct laryngoscopy and bronchoscopy (DLB) without bronchoalveolar lavage (BAL)
* Bleeding disorders
* Allergy to NSAIDs
* Allergy to acetaminophen (Tylenol)
* Pregnancy
Source: ClinicalTrials.gov (NCT07870447). StuddyBuddy aggregates publicly available trial information.