Celecoxib After Tonsillectomy

• Status: Completed
• Trial end date: 2019-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborator: Pfizer
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Calcium Carbonate; Celecoxib; Oxycodone

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.