Celecoxib for Pediatric Adenotonsillectomy - Full Text View

Sponsor:	Children's Hospital of Eastern Ontario
Information provided by (Responsible Party):	Kimmo Murto, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:	NCT00849966

Purpose

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.

Condition	Intervention	Phase
Tonsillectomy Adenotonsillectomy Pain, Postoperative	Drug: Celebrex suspension Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Celecoxib for Pediatric Adenotonsillectomy: A Randomized Controlled Double Blinded Study

Resource links provided by NLM:

MedlinePlus related topics: Tonsils and Adenoids

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To measure the frequency of adverse events post surgery [ Time Frame: For seven days immediately after the procedure ] [ Designated as safety issue: Yes ]
To quantify the impact of celecoxib on fatigue [ Time Frame: Day 0 before the procedure and again on Day 7 afterwards ] [ Designated as safety issue: Yes ]
To quantify the impact of celecoxib on quality of life [ Time Frame: Day 0 before the procedure and again on Day 7 afterwards ] [ Designated as safety issue: Yes ]
To quantify the impact of celecoxib on pain relief postsurgery [ Time Frame: Day 0 before the procedure and every day until Day 7 afterwards ] [ Designated as safety issue: Yes ]
To identify polymorphisms of CYP2C9 genotypes and their impact on pain relief. [ Time Frame: Sample taken during the procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	210
Study Start Date:	August 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Celebrex suspension	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. Other Name: celecoxib
Placebo Comparator: B Placebo	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. Other Name: celecoxib Drug: 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. Other Name: Ora-Blend

Arms

Assigned Interventions

Experimental: A

Celebrex suspension

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.

Other Name: celecoxib

Placebo Comparator: B

Placebo

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.

Other Name: celecoxib

Drug: 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.

Other Name: Ora-Blend

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

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849966

Contacts

Contact: Dr Kimmo Murto, MD

613-737-7600 ext 3065

kmurto@cheo.on.ca

Locations

Canada, Ontario
Children's Hospital of Eastern Ontario	Recruiting
Ottawa, Ontario, Canada, ON K1H 8L1
Contact: Dr Kimmo Murto, MD 613-737-7600 ext 3065 kmurto@cheo.on.ca
Principal Investigator: Kimmo Murto, MD, FRCPC

Sponsors and Collaborators

Children's Hospital of Eastern Ontario

Investigators

Principal Investigator:

Kimmo Murto, MD, FRCPC

Children's Hospital of Eastern Ontario

More Information

Additional Information:

Link to Children's Hospital of Eastern Ontario anesthesiology research page. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Kimmo Murto, Deputy Academic Chief, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:	NCT00849966 History of Changes
Other Study ID Numbers:	#09/10E
Study First Received:	February 20, 2009
Last Updated:	November 9, 2011
Health Authority:	Canada: Health Canada

Keywords provided by Children's Hospital of Eastern Ontario:

Celebrex
celecoxib
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents Non-Steroidal
Adverse drug events

quality of life
Pain Postoperative
Tonsillectomy
Adenotonsillectomy
Otologic Surgical Procedures

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Celecoxib
Anti-Inflammatory Agents
Cyclooxygenase Inhibitors
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cyclooxygenase 2 Inhibitors
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012