Celecoxib After Tonsillectomy

PHASE2CompletedINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

August 17, 2018

Study Completion Date

January 31, 2019

Conditions
Tonsillectomy
Interventions
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.

Trial Locations (1)

19104

Children's Hospital of Philadelphia, Philadelphia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Children's Hospital of Philadelphia

OTHER

NCT02934191 - Celecoxib After Tonsillectomy | Biotech Hunter | Biotech Hunter