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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01099462
Recruitment Status : Unknown
Verified March 2010 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : April 7, 2010
Last Update Posted : April 7, 2010
Information provided by:
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.

Condition or disease Intervention/treatment
Fever Drug: Ibuprofen

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2007
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Group/Cohort Intervention/treatment
Children with fever Drug: 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.

Primary Outcome Measures :
  1. Ibuprofen concentration in the CSF [ Time Frame: 30 - 360 minutes after administration ]

Biospecimen Retention:   Samples Without DNA
Whole blood CSF

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children and Infants 3 month to 18 years of age with fever (rectal temperature >38.0OC or oral temperature > 37.6 OC)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01099462

Contact: Eran Kozer, MD 97289779916

Assaf Harofeh Recruiting
Zerifin, Israel, 70300
Contact: Eran Kozer, MD    97289779916   
Principal Investigator: Eran Kozer, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eran Kozer, Assaf harofeh Medical center Identifier: NCT01099462     History of Changes
Other Study ID Numbers: 199/07*3
First Posted: April 7, 2010    Key Record Dates
Last Update Posted: April 7, 2010
Last Verified: March 2010

Keywords provided by Assaf-Harofeh Medical Center:

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action