Celecoxib for Pediatric Adenotonsillectomy

Pain, Postoperative Clinical Trial

Official title:

Celecoxib for Pediatric Adenotonsillectomy: A Randomized Controlled Double Blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849966
• Other study ID #: #09/10E
• Status: Completed
• Phase: Phase 2
• First received: February 20, 2009
• Last updated: April 17, 2013
• Start date: August 2009
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenotonsillectomy
• Pain, Postoperative
• Tonsillectomy

Intervention

Drug:
• 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.
• Placebo
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.

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario	University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		three days	Yes
Secondary	To measure the frequency of adverse events post surgery		For seven days immediately after the procedure	Yes
Secondary	To quantify the impact of celecoxib on fatigue		Day 0 before the procedure and again on Day 7 afterwards	Yes
Secondary	To quantify the impact of celecoxib on quality of life		Day 0 before the procedure and again on Day 7 afterwards	Yes
Secondary	To quantify the impact of celecoxib on pain relief postsurgery		Day 0 before the procedure and every day until Day 7 afterwards	Yes
Secondary	To identify polymorphisms of CYP2C9 genotypes and their impact on pain relief.		Sample taken during the procedure	Yes

External Links

•   Link to Children's Hospital of Eastern Ontario anesthesiology research page.