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Ibuprofen Concentration in Cerebro Spinal Fluid (CSF) of Infants and Children

Conditions
Fever
Interventions
Registration Number
NCT01099462
Lead Sponsor
Assaf-Harofeh Medical Center
Brief Summary

Ibuprofen, the active ingredient in Nurofen and Advil, is a commonly used drug in children. There is very limited data about Ibuprofen concentrations in the cerebro spinal fluid (CSF). The objective of the current study is to describe concentrations of ibuprofen in the CSF of infants and children after administration of ibuprofen. We will study infants presenting to the Emergency Department (ED) with fever who received ibuprofen. A complete sepsis workup including sampling of blood and CSF is conducted in cases of suspected meningitis. We will measure ibuprofen in the blood and CSF obtained during the sepsis workup. A better understanding of the pharmacokinetics of ibuprofen and its penetration into the CSF will unable us to suggest more accurate dosing guidelines, and to better predict the effects of this commonly used drug.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
Inclusion Criteria
  • Age: 3 month-18 years
  • Rectal temperature > 38.0OC or oral temperature > 37.6 OC measured in the ED or at home.
  • A sepsis work up is indicated
  • At least one dose of Ibuprofen was given in the last 8 hours prior to lumbar puncture (LP)
Exclusion Criteria
  • Hypersensitivity to Ibuprofen
  • Known metabolic disorder
  • Known liver or kidney disease
  • Hydrocephalus
  • Informed consent could not be obtained from a legal guardian

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Children with feverIbuprofen-
Primary Outcome Measures
NameTimeMethod
Ibuprofen concentration in the CSF30 - 360 minutes after administration
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Assaf Harofeh

🇮🇱

Zerifin, Israel

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