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Acetaminophen Concentration in Cerebrospinal Fluid in Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00389454
First Posted: October 18, 2006
Last Update Posted: October 31, 2007
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.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose
Acetaminophen is the most commonly used drug in children. Inhibition of COX-3 in the brain has been suggested as the primary central mechanism by which acetaminophen decrease pain and possibly fever. However there is very limited data about acetaminophen concentrations in the brain and no such data is available for newborns. The objective of the current study is to describe concentrations of acetaminophen in the fluid around the brain of infants after administration of acetaminophen.

Condition
Fever

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Acetaminophen Concentration in Cerebrospinal Fluid in Infants

Resource links provided by NLM:


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

Study Start Date: January 2004
Study Completion Date: June 2007
Detailed Description:

The mechanism by which acetaminophen causes analgesia and antipyretic effect is not entirely clear. Recently a new COX isoenzyme was identified and termed COX 3. In humans this isoenzyme is most abundant in cerebral cortex and heart. Inhibition of COX-3 could represent a primary central mechanism by which acetaminophen decrease pain and possibly fever (10). An effect on of acetaminophen on presynaptic 5-HT(2) receptors in the hypocampus has been demonstrated (11) suggesting again that the primary effect of acetaminophen is in the CNS.

Many studies (12-16) described the pharmacokinetics of oral and rectal acetaminophen in infants and neonates. Yet, the data on acetaminophen concentrations in the CSF is very limited. Two studies in adults (17;18) used intravenous propacetamol and described concentrations of acetaminophen in the plasma and CSF. Acetaminophen was detected as early as 15 minutes after the administration and reached peak concentrations in the CSF at the 4th hour. A small study (19) of nine children who had indwelling ventricular drains found that cerebrospinal fluid concentrations lagged behind those of plasma with an equilibration half time of 0.72 h. This study did not describe CSF concentrations in neonates and used a dose of 40mg/kg, which is higher than the recommended dose in children. To the best of our knowledge there is no data on acetaminophen CSF concentrations in neonates.

The objective of the current study is to describe concentrations of acetaminophen in the CSF of infants after single administration of acetaminophen. A better understanding of the pharmacokinetics of acetaminophen and its penetration into the CSF will enable us to better predict the effects of this commonly used drug.

  Eligibility

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 1week - 2 years
  • Rectal temperature > 38.0OC
  • A sepsis work up is indicated
  • Acetaminophen was given prior to lumbar puncture (LP)

Exclusion Criteria:

  • Hypersensitivity to acetaminophen
  • Known metabolic disorder
  • Known liver or kidney disease
  • Hydrocephalus
  • Informed consent could not be obtained from a legal guardian
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00389454


Locations
Israel
Pediatric Emergency Unit Assaf Harofeh Medical center
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Eran Kozer, MD Assaf-Harofeh Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00389454     History of Changes
Other Study ID Numbers: 93/03
First Submitted: October 17, 2006
First Posted: October 18, 2006
Last Update Posted: October 31, 2007
Last Verified: August 2006

Keywords provided by Assaf-Harofeh Medical Center:
Acetaminophen
Fever
cerebro spinal fluid
Infants

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics