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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Fever

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with fever

Ibuprofen

Intervention Type DRUG

Ibuprofen (10mg/kg BW) will be given orally if the temperature on presentation is higher than 38.0OC according to the decision of the attending physician.

Interventions

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Ibuprofen

Ibuprofen (10mg/kg BW) will be given orally if the temperature on presentation is higher than 38.0OC according to the decision of the attending physician.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No