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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01099462
First received: April 6, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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 Intervention
Fever
Drug: Ibuprofen

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Ibuprofen concentration in the CSF [ Time Frame: 30 - 360 minutes after administration ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole blood CSF


Estimated Enrollment: 30
Study Start Date: June 2007
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
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)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099462

Contacts
Contact: Eran Kozer, MD 97289779916 erank@asaf.health.gov.il

Locations
Israel
Assaf Harofeh Recruiting
Zerifin, Israel, 70300
Contact: Eran Kozer, MD    97289779916    erank@asaf.health.gov.il   
Principal Investigator: Eran Kozer, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Eran Kozer, Assaf harofeh Medical center
ClinicalTrials.gov Identifier: NCT01099462     History of Changes
Other Study ID Numbers: 199/07*3
Study First Received: April 6, 2010
Last Updated: April 6, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Assaf-Harofeh Medical Center:
fever
Ibuprofen

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

ClinicalTrials.gov processed this record on September 30, 2014