NCT02934191

Celecoxib After Tonsillectomy

Celecoxib for Pain Management After Tonsillectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tonsillectomy

Interventions

Type	Name	Description
DRUG	Celecoxib	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
OTHER	Placebo	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.
DRUG	Acetaminophen	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.
DRUG	Oxycodone	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.

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-08-17
• Completion: 2019-01-31
• First posted: 2016-10-14
• Last updated: 2020-03-10
• Results posted: 2019-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study