- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00849966
Celecoxib for Pediatric Adenotonsillectomy
Celecoxib for Pediatric Adenotonsillectomy: A Randomized Controlled Double Blinded Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, ON K1H 8L1
- Children's Hospital of Eastern Ontario
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: B
Placebo
|
Patients will be randomized to receive celecoxib suspension 6 mg/kg one hour prior to their scheduled surgery. In addition the patient will receive seven weight-based doses of celecoxib (3 mg/kg) to be administered every 10-12 hours while the child is awake; the first dose being administered the evening of surgery. All participants will receive undergo and post surgery anesthetic treatment according to the usual standards of practice at CHEO.
Other Names:
Patients will be randomized to receive placebo by mouth one hour prior to their scheduled surgery. In addition the patient will receive seven weight-based doses of the placebo to be administered every 10-12 hours while the child is awake; the first dose being administered the evening of surgery. All participants will receive undergo and post surgery anesthetic treatment according to the usual standards of practice at CHEO.
Other Names:
|
Experimental: A
Celebrex suspension
|
Patients will be randomized to receive celecoxib suspension 6 mg/kg one hour prior to their scheduled surgery. In addition the patient will receive seven weight-based doses of celecoxib (3 mg/kg) to be administered every 10-12 hours while the child is awake; the first dose being administered the evening of surgery. All participants will receive undergo and post surgery anesthetic treatment according to the usual standards of practice at CHEO.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: three days
|
three days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To measure the frequency of adverse events post surgery
Time Frame: For seven days immediately after the procedure
|
For seven days immediately after the procedure
|
To quantify the impact of celecoxib on fatigue
Time Frame: Day 0 before the procedure and again on Day 7 afterwards
|
Day 0 before the procedure and again on Day 7 afterwards
|
To quantify the impact of celecoxib on quality of life
Time Frame: Day 0 before the procedure and again on Day 7 afterwards
|
Day 0 before the procedure and again on Day 7 afterwards
|
To quantify the impact of celecoxib on pain relief postsurgery
Time Frame: Day 0 before the procedure and every day until Day 7 afterwards
|
Day 0 before the procedure and every day until Day 7 afterwards
|
To identify polymorphisms of CYP2C9 genotypes and their impact on pain relief.
Time Frame: Sample taken during the procedure
|
Sample taken during the procedure
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kimmo Murto, MD, FRCPC, Children's Hospital of Eastern Ontario
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
Other Study ID Numbers
- #09/10E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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