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.

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.

Bias reduction in calculation of inpatient fall rates.

Inpatient falls are the most common adverse hospital events. Despite the recognized importance of reducing inpatient falls, tracking and reporting methods are inconsistent. Moreover, recommended methods and statistical tests for comparing rates are complicated. This article demonstrates how to calculate fall rates using 3 common methods, summarizes the advantages and disadvantages of each method, and recommends best practices.

Case report of tetanus in an immunized, healthy adult and no point of entry.

We report the case of a 58-year-old man born in the United States with a history of complete childhood immunizations who presented to the Emergency Department with trismus. Past medical history was significant only for Elephantiasis. After an exhaustive workup the patient was found to have Tetanus, with no identifiable portal of entry. The patient was successfully treated for Tetanus with complete recovery. Tetanus is caused by the organism Clostridium Tetani, which usually requires an open lesion to cause infection. Our patient was unique in that he was previously immunized with no obvious lesion. Tetanus should be suspected and treated empirically in any patient presenting with typical signs and symptoms even without an apparent entry site.