- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00389454
Acetaminophen Concentration in Cerebrospinal Fluid in Infants
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Kontakter och platser
Studieorter
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Zerifin, Israel, 70300
- Pediatric Emergency Unit Assaf Harofeh Medical center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Eran Kozer, MD, Assaf-Harofeh Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 93/03
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