Pharmakokinetics and Pharmacodynamics of Acetaminophen( paracetamol i.v) in Neonates

• Conditions: We want to determine the optimal loading dose of intravenous Acetaminophen in neonates of different gestational age subgroups.To this effect a loading dose of 10mg/kg, 15mg/kg or 20mg/kg Acetaminophen will beadministered to neonates with a gestational age of 24 –42 weeks when they need to endurea mild painful procedure. All concentration-time profiles will be used in a pharmacokineticanalysis of acetaminophen using a non-linear mixed effects model (NONMEM).

• Registration Number: EUCTR2009-013456-76-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Inclusion criteria
·neonates (in- and outborn) with a gestational age of 24-42 weeks
·admission within the first 24 hours of life
·indwelling arterial catheter
·painful procedures within the first week of life
·Informed consent of the parents or legal guardian

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

4.3.Exclusion criteria
· major congenital anomalies
· intraventriculair haemorrhage > grade 2
· neuromuscular blockers
· absence of an indwelling catheter
· use of morphine, midazolam or sucrose at start of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified