A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults.

ABSTRACT:

Introduction

Hospitalized patients are often unable to ingest or tolerate oral antipyretics and recently an aqueous formulation of intravenous (IV) ibuprofen was approved by the US-FDA for the reduction of fever in adults.

Methods

We evaluated IV ibuprofen to reduce fever exceeding 101.0 degrees F, measured as the percentage of subjects achieving a temperature <101.0 degrees F at four hours after a single dose of IV ibuprofen vs. placebo. Secondary evaluations included the effect on temperature at 24 hours. Nine sites randomized patients to receive either a placebo or IV ibuprofen (100, 200, or 400 mg), and patients were given four hours for six doses. Subjects were excluded for platelet count <30 k and/or creatinine >3.0 mg/dL.

Results

At entry, there were no signifi

SUBMITTER: Morris PE 

PROVIDER: S-EPMC2911773 | biostudies-literature | 2010

REPOSITORIES: biostudies-literature