Celecoxib for Pediatric Adenotonsillectomy
Condition: Tonsillectomy; Adenotonsillectomy; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Celebrex suspension; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): celecoxib; Ora-Blend
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Celebrex; celecoxib; Cyclooxygenase Inhibitors; Anti-Inflammatory Agents Non-Steroidal; Adverse drug events; quality of life; Pain Postoperative; Tonsillectomy; Adenotonsillectomy; Otologic Surgical Procedures