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BMC Pediatr. 2017 Feb 1;17(1):42. doi: 10.1186/s12887-017-0795-y.

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.

Author information

1
Department of Anesthesiology, The University of Texas Medical School at Houston, 6431 Fannin Street, MSB 5.020, Houston, TX, 77030, USA.
2
Department of Emergency Medicine, Staten Island University Hospital, 475 Seaview Avenue, Staten Island, New York, 10305, USA.
3
Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, 6621 Fannin Street, Suite A2210, Houston, TX, 77030, USA.
4
Cumberland Pharmaceuticals Inc., 2525 West End Avenue, Suite 950, Nashville, TN, 37203, USA.
5
Cumberland Pharmaceuticals Inc., 2525 West End Avenue, Suite 950, Nashville, TN, 37203, USA. bkaelin@cumberlandpharma.com.

Abstract

BACKGROUND:

Oral antipyretics are commonly used to treat pediatric patients who develop fevers. However, patients presenting to the emergency department or undergoing surgery are frequently unable to tolerate oral antipyretics. Rectal formulations are available; however, this route of administration is unpredictable. The main objectives of this randomized controlled study was to evaluate the efficacy and safety of single or multiple doses of intravenous ibuprofen to acetaminophen (oral or suppository) in pediatric patients with fever and to assess plasma ibuprofen concentrations.

METHODS:

This multi-center study was conducted in hospitalized patients, ≤ 16 years, with a new onset of fever ≥ 38.3°C. Patients were randomly assigned to receive either 10 mg/kg intravenous ibuprofen or acetaminophen. Study drug was administered at hour 0, and thereafter every 4 h as needed, up to 5 days. The primary outcome was to evaluate the effect of a single dose of intravenous ibuprofen compared to acetaminophen in reducing temperature in the first 2 h after administration. Data were compared using an analysis of variance model for continuous measurements and Cochran-Mantel-Haenszel test of general association for categorical data. A two-sided testing was used and a p-value ≤ 0.05 was considered significant.

RESULTS:

A total of 103 patients received study medication. 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) and 4 h (<0.001); in a greater reduction in change from baseline temperature compared to treatment with acetaminophen, and it reduced fever throughout a 24 h dosing period. There were no differences in safety parameters or serious adverse events.

CONCLUSIONS:

A single 10 mg/kg dose of intravenous ibuprofen 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. A reduction in temperature was also demonstrated over 24 h; however the reduction was not considered statically significant. Intravenous ibuprofen provides an effective option for reducing fever in hospitalized pediatric patients.

TRIAL REGISTRATION:

The study was registered on ClinicalTrials.gov on 26 October 2009, Study Identifier: NCT01002573.

KEYWORDS:

Antipyretic; Fever; Ibuprofen; NSAIDs; Pediatric

PMID:
28143430
PMCID:
PMC5286864
DOI:
10.1186/s12887-017-0795-y
[Indexed for MEDLINE]
Free PMC Article

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