Clinical trial NCT00849966: Celecoxib for Pediatric Adenotonsillectomy
Official title: Celecoxib for Pediatric Adenotonsillectomy: A Randomized Controlled Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tonsillectomy
Adenotonsillectomy
Pain, Postoperative
Keywords: Celebrex
celecoxib
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents Non-Steroidal
Adverse drug events
quality of life
Pain Postoperative
Tonsillectomy
Adenotonsillectomy
Otologic Surgical Procedures
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: University of Ottawa
First posted: 2009-02-24
Enrollment: 282
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 life and side effect profile.

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 life inventory, multi-dimension fatigue scale and pediatric pain questionnaire for the preceding week. Children/adolescents aged 8 to 18 years of age will be required to complete a child self-report of the same modules. Children undergoing adenotonsillectomy will receive either placebo or celecoxib by mouth one hour prior to their surgery. They will all receive preoperative acetaminophen. Premedication with midazolam will be at the discretion of the attending anesthesiologist. The patients will undergo a standardized anesthetic protocol including postoperative management of pain and nausea and vomiting. The patients, while under anesthesia, will have blood drawn to screen for occult liver and kidney disease, determine their CYP2C9 genotype and reserve for future gene chip micro array analysis.

Patients in both study arms will receive a second dose of celecoxib or placebo by mouth in the evening after surgery and then consecutively in the morning and evening for 72 hours. For seven days after the surgery the families will record once a day pain scores, document analgesic use and any side effects or adverse events. The families will be contacted by phone in the evening of the first three postoperative days to ensure that they understand and are completing the required documentation. On the seventh postoperative day the parents and children aged 8 to 18 years of age will be contacted by phone and instructed to complete the same two validated questionnaires concerning quality of life and level of fatigue completed on the day of surgery. Parents of children less than eight years of age will be responsible for completing these questionnaires based on observations of their children. On the 11th postoperative day the families will be contacted by e-mail or regular mail to complete a questionnaire asking about the extent of contact with the healthcare system, bleeding complications, recovery and overall satisfaction with their care.

Eligibility 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

Primary outcomes:
measure: The investigators primary objective will be to determine the level of postoperative pain relief celecoxib provides for children within the first three days after undergoing tonsillectomy, or adenotonsillectomy
timeFrame: three days
Secondary outcomes:
measure: To measure the frequency of adverse events post surgery
timeFrame: For seven days immediately after the procedure
measure: To quantify the impact of celecoxib on fatigue
timeFrame: Day 0 before the procedure and again on Day 7 afterwards
measure: To quantify the impact of celecoxib on quality of life
timeFrame: Day 0 before the procedure and again on Day 7 afterwards
measure: To quantify the impact of celecoxib on pain relief postsurgery
timeFrame: Day 0 before the procedure and every day until Day 7 afterwards
measure: To identify polymorphisms of CYP2C9 genotypes and their impact on pain relief.
timeFrame: Sample taken during the procedure
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Kimmo Murto, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murto K, Lamontagne C, McFaul C, MacCormick J, Ramakko KA, Aglipay M, Rosen D, Vaillancourt R. Celecoxib pharmacogenetics and pediatric adenotonsillectomy: a double-blinded randomized controlled study. Can J Anaesth. 2015 Jul;62(7):785-97. doi: 10.1007/s12630-015-0376-1. Epub 2015 Apr 7.