Celecoxib After Tonsillectomy

Inclusion Criteria

• Males and females age 3 to 11 years inclusive.
• Scheduled to undergo tonsillectomy (with or without adenoidectomy).
• Weight ≥10 kg.
• Girls ≥ 11 years of age must have a negative urine/serum pregnancy test on the day of surgery and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
• Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria

• Prior adenotonsillar surgery.
• Concomitant surgical procedure that adds more than mild additional pain. Note: ear tubes are always permissible.
• Coagulation disorder, or any other hematologic disorder that affects clotting or results in anemia.
• Moderate to severe asthma, defined as subjects who either (1) have daily symptoms requiring daily use of short-acting bronchodilators, or (2) had an exacerbation in the last 3 months requiring admission, emergency department (ED) visit, or systemic corticosteroid administration.
• Any degree of aspirin-sensitive asthma, or any history of asthma exacerbation caused by NSAID use.
• Severe obstructive sleep apnea, defined as an obstructive apnea-hypopnea index >30 per hour and/or lowest oxygen saturation below 80%
• Significant chronic pulmonary disease, defined as subjects requiring oxygen therapy, ventilator support, or positive pressure therapy.
• Significant cardiac disease, defined as any one of the following: cardiovascular disease, structural cardiac anomalies, prior cardiac surgery, or requirement for cardiac anesthesia.
• Severely obese (weight or body mass index > 95th percentile for age) or underweight (weight <5th percentile for age).
• History of hepatic or renal disease, or condition that impairs hepatic or renal function.
• Juvenile rheumatoid arthritis (JRA).
• History of GI bleeding, or chronic GI condition that would increase risk of bleeding, ulceration, or perforation
• Hypertension.
• Craniofacial syndromes.
• Syndrome or neurologic condition that would hinder accurate assessment of postoperative pain.
• Inability to feed orally or take oral pain medication.
• Chronic pain disorders, or otherwise requiring pain medication more than once weekly.
• Laboratory abnormalities on the preoperative complete blood count (CBC):
• Hemoglobin < 9 gm/dL
• Platelet count < 100,000/mm3
• Any investigational drug use within 30 days prior to enrollment.
• Pregnant or lactating females.
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
• Hypersensitivity or allergic reactions to celecoxib, aspirin, or other NSAIDs, including asthma flare ups
• Allergy to sulfonamides or calcium carbonate.