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

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

Outcome

Met primary endpoint

paper Intravenous ibuprofen resulted in a greater reduction in temperature as measured by the area under the change from baseline at 2 h (p = 0.005) PMID 28143430 ↗

paper provided a significant reduction of temperature for febrile pediatric patients compared to those that received 10 mg/kg acetaminophen at 2 h and 4 h post-treatment. PMID 28143430 ↗

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.