Celecoxib After Tonsillectomy
Condition: Tonsillectomy
Study type: Interventional
Phase: Phase 2

Summary: 
      Tonsillectomy is one of the most common pediatric surgical procedures in the United States.
      Postoperative pain is substantial, with typical regimens employing narcotic derivatives and
      acetaminophen for 1-2 weeks after surgery. Recent enthusiasm for use of ibuprofen as an
      alternative has been tempered by equivocal data on its relative safety in regard to risk of
      postoperative hemorrhage. The primary objective is to evaluate efficacy of celecoxib for pain
      control after tonsillectomy in children. The secondary objective is to assess safety in
      regard to postoperative hemorrhage and adverse events.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled trial. Subjects will take
      acetaminophen plus either celecoxib or placebo in regular scheduled doses, and will
      supplement as needed with standard of care analgesic therapy (oxycodone/acetaminophen).

      Celecoxib is approved by the FDA for use in children ages 2 and older for treatment of
      juvenile rheumatoid arthritis (JRA). Celecoxib is on the Children's Hospital of Philadelphia
      (CHOP) formulary for use in (1) patients >= 2 years old for JRA, (2) patients >= 12 years old
      and >=40 kg who have increased risk for gastrointestinal (GI) adverse effects or bleeding
      concerns precluding use of traditional nonsteroidal anti-inflammatory drugs (NSAIDs), and (3)
      oncology patients with surface area >= 0.4 square meters for anti-angiogenesis. Celecoxib is
      approved by the FDA for use in adults for treatment of arthritic conditions, acute/
      postoperative pain, and primary dysmenorrhea, and has been widely used since its introduction
      in 1998.

      Setting/Participants:Subjects are healthy children aged 3 to 11 years who undergo
      tonsillectomy with or without adenoidectomy at any Children's Hospital of Philadelphia (CHOP)
      location. Subjects with coagulation disorders are excluded. Approximately 300 subjects will
      be enrolled, 150 in each treatment group.

      Study Interventions and Measures: Subjects are provided celecoxib or placebo in scheduled
      doses every 12 hours for 5 days, then continue until they are pain-free, for a maximum of 10
      days. Throughout the study, they are allowed to use oxycodone/acetaminophen as needed for
      additional pain control, following standard clinical care. Acetaminophen is used around the
      clock for the first 5 days in all subjects. For 14 days following surgery, subjects record
      pain levels on validated pain scale instruments, quantity of narcotic medication and
      acetaminophen required, and time to return to normal diet. All Emergency Department and
      hospital admissions during the 30 postoperative days are recorded, noting incidence of excess
      pain, dehydration, hemorrhage, and other complications.

      Pain control efficacy is assessed by comparing groups for number of days in which narcotic
      medication was used, and total quantity of rescue pain medication consumed. Rates of hospital
      readmission and postoperative hemorrhage, and the need for operative control, are also
      compared between groups.
    

Intervention name(s): Celecoxib; Placebo; Acetaminophen; Oxycodone
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally; Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day.; Acetaminophen syrup at a dose of 15mg/kg/dose will be given every 4 hours for the first 5 days after surgery. After that point, is given as needed.; Oxycodone may be used every 4 hours post-operatively to treat breakthrough pain. The most commonly prescribed dose is 0.075mg/kg/dose (suspension) every 4 hours as needed.
Other intervention name(s): Celebrex; Calcium carbonate placebo
Intervention MeSH terms: Acetaminophen; Celecoxib; Oxycodone; Calcium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tonsillectomy; Post-operative complications; Post-operative pain