Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Phase 3 Completed 118 enrolled Cumberland Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.

Timeline

Start: 2010-07
Primary completion: 2013-06
Completion: 2013-06

Publications

Khalil SN, Hahn BJ, Chumpitazi CE, Rock AD, Kaelin BA, Macias CG. A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients. BMC Pediatr. 2017 Feb 1;17(1):42. doi: 10.1186/s12887-017-0795-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetaminophen	Small molecule	10 mg/kg	Oral
Subject	Ibuprofen	Small molecule	10 mg/kg	Intravenous

Indications

No indication recorded.