Celecoxib for Pediatric Adenotonsillectomy
Information source: Children's Hospital of Eastern Ontario
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tonsillectomy; Adenotonsillectomy; Pain, Postoperative
Intervention: Celebrex suspension (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Children's Hospital of Eastern Ontario Official(s) and/or principal investigator(s): Kimmo Murto, MD, FRCPC, Principal Investigator, Affiliation: Children's Hospital of Eastern Ontario
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.
Clinical Details
Official title: Celecoxib for Pediatric Adenotonsillectomy: A Randomized Controlled Double Blinded Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: To measure the frequency of adverse events post surgeryTo quantify the impact of celecoxib on fatigue To quantify the impact of celecoxib on quality of life To quantify the impact of celecoxib on pain relief postsurgery To identify polymorphisms of CYP2C9 genotypes and their impact on pain relief.
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
Minimum age: 2 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Children's Hospital of Eastern Ontario, Ottawa, Ontario ON K1H 8L1, Canada
Additional Information
Link to Children's Hospital of Eastern Ontario anesthesiology research page.
Starting date: August 2009
Last updated: April 17, 2013
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