Celecoxib for Pediatric Adenotonsillectomy

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators' study will involve the administration of either placebo or celecoxib to children aged 2 to 18 years of age undergoing tonsillectomy and assessing pain relief, impact on quality of life and side effect profile.

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

Details

• Lead Sponsor: Children's Hospital of Eastern Ontario
• Collaborator: University of Ottawa
• Treatments: Celecoxib

Criteria

Inclusion Criteria:

• Children aged 2-18 years

• Tonsillectomy, or adenotonsillectomy

• No exclusion criteria

Exclusion Criteria:

• Age < 2yrs and >18yrs old

• BMI < 10th or > 95th percentile

• Serum creatinine (Cr) > 2 X UNL (upper normal limit)

• Abnormal liver function; namely alanine aminotransferase (ALT) > 1.5 X UNL, alkaline phosphatase (ALP) > 5X UNL, total bilirubin > 2 X UNL

• History of peptic ulcer disease.

• History of bleeding disorders

• History of severe asthma (requiring recent hospital admission or oral corticosteroid therapy)

• Allergy to celecoxib, sulfonamide compounds or NSAIDs

• Patients receiving CYP2C9 inhibitors fluconazole, amiodarone and oxandrolone

• Patients receiving CYP2C9 inducers rifampin and phenobarbital

• Extremes of body mass index (BMI) (age related below10th or above 90th percentile)

• Parents of any participants, irrespective of age, who are unable to read and understand instructions relayed in English or French

• Participant and/or parents of any participants, irrespective of age, who suffer from dementia, psychosis, significant developmental delay or other impairment that would prohibit the understanding and giving of informed consent or assent or the participation in self-care or toxicity reporting