Celecoxib for Pediatric Adenotonsillectomy

NCT00849966 | Completed Phase 2 DMC

• 1 other identifier: #09/10E
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tonsillectomy; Adenotonsillectomy; Pain, Postoperative

Keywords

Celebrex; celecoxib; Cyclooxygenase Inhibitors; Anti-Inflammatory Agents Non-Steroidal; Adverse drug events; quality of life; Pain Postoperative; Tonsillectomy; Adenotonsillectomy; Otologic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• To measure the frequency of adverse events post surgery

  For seven days immediately after the procedure

• To quantify the impact of celecoxib on fatigue

  Day 0 before the procedure and again on Day 7 afterwards

• To quantify the impact of celecoxib on quality of life

  Day 0 before the procedure and again on Day 7 afterwards

• To quantify the impact of celecoxib on pain relief postsurgery

  Day 0 before the procedure and every day until Day 7 afterwards

• To identify polymorphisms of CYP2C9 genotypes and their impact on pain relief.

  Sample taken during the procedure

Study Arms (2)

A

EXPERIMENTAL

Celebrex suspension

Drug: Celebrex suspension

B

PLACEBO COMPARATOR

Placebo

Drug: Celebrex suspension; Drug: Placebo

Interventions

Celebrex suspension DRUG

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

A; B

Placebo DRUG

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

B

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 2-18 years
• Tonsillectomy, or adenotonsillectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• University of Ottawa: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, ON K1H 8L1, Canada

Location

Related Publications (1)

• Murto K, Lamontagne C, McFaul C, MacCormick J, Ramakko KA, Aglipay M, Rosen D, Vaillancourt R. Celecoxib pharmacogenetics and pediatric adenotonsillectomy: a double-blinded randomized controlled study. Can J Anaesth. 2015 Jul;62(7):785-97. doi: 10.1007/s12630-015-0376-1. Epub 2015 Apr 7.

  PMID: 25846344 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Drug-Related Side Effects and Adverse Reactions

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kimmo Murto, MD, FRCPC

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Academic Chief

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 24, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 18, 2013

Record last verified: 2013-04

Locations

CA (1)