Ibuprofen Concentration in Cerebro Spinal Fluid (CSF) of Infants and Children
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 6, 2010
CompletedFirst Posted
Study publicly available on registry
April 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedApril 7, 2010
March 1, 2010
3.5 years
April 6, 2010
April 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ibuprofen concentration in the CSF
30 - 360 minutes after administration
Study Arms (1)
Children with fever
Interventions
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.
Eligibility Criteria
children and Infants 3 month to 18 years of age with fever (rectal temperature \>38.0OC or oral temperature \> 37.6 OC)
You may qualify if:
- 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)
You may not qualify if:
- Hypersensitivity to Ibuprofen
- Known metabolic disorder
- Known liver or kidney disease
- Hydrocephalus
- Informed consent could not be obtained from a legal guardian
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assaf Harofeh
Ẕerifin, 70300, Israel
Related Publications (1)
Har-Even R, Stepensky D, Britzi M, Soback S, Chaim AB, Brandriss N, Goldman M, Berkovitch M, Kozer E. Plasma and cerebrospinal fluid concentrations of ibuprofen in pediatric patients and antipyretic effect: Pharmacokinetic-pharmacodynamic modeling analysis. J Clin Pharmacol. 2014 Sep;54(9):1023-30. doi: 10.1002/jcph.307. Epub 2014 Apr 21.
PMID: 24733245DERIVED
Biospecimen
Whole blood CSF
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
April 6, 2010
First Posted
April 7, 2010
Study Start
June 1, 2007
Primary Completion
December 1, 2010
Study Completion
June 1, 2011
Last Updated
April 7, 2010
Record last verified: 2010-03