A Phase 2 interventional study of Celebrex suspension and Placebo in Tonsillectomy, Adenotonsillectomy and Pain, Postoperative, sponsored by Children's Hospital of Eastern Ontario. Completed at 1 site in Canada. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2013-04-18.
Sponsored by Children's Hospital of Eastern Ontario · Phase 2, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 282 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Children's Hospital of Eastern Ontario is the lead sponsor of 83 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Celebrex suspension
Drug: Celebrex suspension
Placebo
Drug: Celebrex suspension · Drug: 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.
Also known as: celecoxib
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.
Also known as: Ora-Blend
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
To measure the frequency of adverse events post surgery
Time frame: 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
To quantify the impact of celecoxib on quality of life
Time frame: 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
To identify polymorphisms of CYP2C9 genotypes and their impact on pain relief.
Time frame: Sample taken during the procedure
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Eastern Ontario