Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy

PHASE3CompletedINTERVENTIONAL
Enrollment

161

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

August 31, 2012

Conditions
Tonsillectomy
Interventions
DRUG

Intravenous ibuprofen

Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.

OTHER

Normal Saline

Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.

Trial Locations (6)

15224

Children's Hospital of Pittsburgh, Pittsburgh

28210

Southeastern Clinical Research Associates, Charlotte

37075

Comprehensive Pain Specialists, Hendersonville

40207

Advanced ENT & Allergy, Louisville

77030

Baylor College of Medicine/Texas Children's Hospital, Houston

07101

University Hospital, University of Medicine and Dentistry NJ, Newark

Sponsors
All Listed Sponsors
lead

Cumberland Pharmaceuticals

INDUSTRY

NCT01332253 - Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy | Biotech Hunter | Biotech Hunter