ABOUT THIS STUDY
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.
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
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
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
11. Juvenile rheumatoid arthritis (JRA).
12. History of GI bleeding, or chronic GI condition that would increase risk of bleeding,
ulceration, or perforation
14. Craniofacial syndromes.
15. Syndrome or neurologic condition that would hinder accurate assessment of
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.
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