Celecoxib After Tonsillectomy
Condition: Tonsillectomy
Intervention: Celecoxib; Placebo; Acetaminophen; Oxycodone
Intervention description: Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally; Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day.; Acetaminophen syrup at a dose of 15mg/kg/dose will be given every 4 hours for the first 5 days after surgery. After that point, is given as needed.; Oxycodone may be used every 4 hours post-operatively to treat breakthrough pain. The most commonly prescribed dose is 0.075mg/kg/dose (suspension) every 4 hours as needed.
Intervention MeSH terms: Acetaminophen; Celecoxib; Oxycodone; Calcium Carbonate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 172.0
Sex: All
Minimum age: 3 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Tonsillectomy; Post-operative complications; Post-operative pain

Summary:

      Tonsillectomy is one of the most common pediatric surgical procedures in the United States.
      Postoperative pain is substantial, with typical regimens employing narcotic derivatives and
      acetaminophen for 1-2 weeks after surgery. Recent enthusiasm for use of ibuprofen as an
      alternative has been tempered by equivocal data on its relative safety in regard to risk of
      postoperative hemorrhage. The primary objective is to evaluate efficacy of celecoxib for pain
      control after tonsillectomy in children. The secondary objective is to assess safety in
      regard to postoperative hemorrhage and adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females age 3 to 11 years inclusive.

          2. Scheduled to undergo tonsillectomy (with or without adenoidectomy).

          3. Weight ≥10 kg.

          4. 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.

          5. Parental/guardian permission (informed consent) and if appropriate, child assent.

        Exclusion Criteria:

          1. Prior adenotonsillar surgery.

          2. Concomitant surgical procedure that adds more than mild additional pain. Note: ear
             tubes are always permissible.

          3. Coagulation disorder, or any other hematologic disorder that affects clotting or
             results in anemia.

          4. 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.

          5. Any degree of aspirin-sensitive asthma, or any history of asthma exacerbation caused
             by NSAID use.

          6. Severe obstructive sleep apnea, defined as an obstructive apnea-hypopnea index >30 per
             hour and/or lowest oxygen saturation below 80%

          7. Significant chronic pulmonary disease, defined as subjects requiring oxygen therapy,
             ventilator support, or positive pressure therapy.

          8. Significant cardiac disease, defined as any one of the following: cardiovascular
             disease, structural cardiac anomalies, prior cardiac surgery, or requirement for
             cardiac anesthesia.

          9. Severely obese (weight or body mass index > 95th percentile for age) or underweight
             (weight <5th percentile for age).

         10. History of hepatic or renal disease, or condition that impairs hepatic or renal
             function.

         11. Juvenile rheumatoid arthritis (JRA).

         12. History of GI bleeding, or chronic GI condition that would increase risk of bleeding,
             ulceration, or perforation

         13. Hypertension.

         14. Craniofacial syndromes.

         15. Syndrome or neurologic condition that would hinder accurate assessment of
             postoperative pain.

         16. Inability to feed orally or take oral pain medication.

         17. Chronic pain disorders, or otherwise requiring pain medication more than once weekly.

         18. Laboratory abnormalities on the preoperative complete blood count (CBC):

               -  Hemoglobin < 9 gm/dL

               -  Platelet count < 100,000/mm3

         19. Any investigational drug use within 30 days prior to enrollment.

         20. Pregnant or lactating females.

         21. Parents/guardians or subjects who, in the opinion of the Investigator, may be
             non-compliant with study schedules or procedures.

         22. Hypersensitivity or allergic reactions to celecoxib, aspirin, or other NSAIDs,
             including asthma flare ups

         23. Allergy to sulfonamides or calcium carbonate.