Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389454
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2006-10-17
Brief Title:
Acetaminophen Concentration in Cerebrospinal Fluid in Infants
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Acetaminophen Concentration in Cerebrospinal Fluid in Infants
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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-HT2 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 1718 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 072 h This study did not describe CSF concentrations in neonates and used a dose of 40mgkg 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
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 1718 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 072 h This study did not describe CSF concentrations in neonates and used a dose of 40mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None