An Open-Label, Randomized Study of Preoperative Celecoxib After Pediatric Adenotonsillectomy
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).
Description
This is an open-label, randomized, parallel-group study of a preoperative multimodal analgesic regimen versus standard-of-care no pre-operative analgesia in pediatric patients aged 2-18 years and weighing more than 10 kg who are undergoing adenotonsillectomy. Multimodal arm: oral celecoxib (6 mg/kg, max 100 mg) the evening before surgery and the morning of surgery, plus intra-operative dexamethasone (Decadron) and acetaminophen (Tylenol). Standard-of-care arm: no pre-operative medication; intra-operative dexamethasone (Decadron) and acetaminophen (Tylenol). In both arms, the post-operative re…
Eligibility
- Age range
- 2–18 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugCelecoxib
Oral celecoxib 6 mg/kg per dose (max 100 mg), given the evening before surgery and the morning of surgery
- DrugAcetaminophen
Intra-operative acetaminophen (Tylenol)
- DrugDexamethasone
Intra-operative dexamethasone (Decadron)
Location
- NYU Langone HealthNew York, New York