Status:
COMPLETED
Celecoxib for Pediatric Adenotonsillectomy
Lead Sponsor:
Children's Hospital of Eastern Ontario
Collaborating Sponsors:
University of Ottawa
Conditions:
Tonsillectomy
Adenotonsillectomy
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
Brief 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 l...
Detailed Description
The study will consist of two arms, one placebo and the other celecoxib. To establish baseline data on the day of surgery the parents will be required to complete a validated parent report quality of ...
Eligibility Criteria
Inclusion
- Children aged 2-18 years
- Tonsillectomy, or adenotonsillectomy
- No exclusion criteria
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT00849966
Start Date
August 1 2009
End Date
December 1 2012
Last Update
April 18 2013
Active Locations (1)
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1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, ON K1H 8L1