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 be administered to neonates with a gestational age of 24 –42 weeks when they need to endure a mild painful procedure. All concentration-time profiles will be used in a pharmacokinetic analysis of acetaminophen using a non-linear mixed effects model (NONMEM).
Conditions
Interventions
Trade Name: Perfalgan
Pharmaceutical Form: Intravenous infusion
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: Pharmacokinetic properties of Acetaminophen in neonates: Safety and Efficacy Profile: Determine optimal loading dose of Acetaminophen in different age-subgroup. Safety outcome parameters are: - acetaminophen serum levels, - acetaminophen metabolite levels in urine samples - renal function - hepatotoxicity (determine NAPQ1levels as indicator). Pharmacodynamic properties of Acetaminophen in neonates: Comfortneo score and PIPP as pain assessment tools used in the different dose regimens of acetaminophen compared to the control group receiving sucrose.;Secondary Objective: Secondary Objective(s): Registration and/or drug interaction: - Influence of drugs metabolised by cytochrome P-450 on serum levels of acetaminophen: indomethacin; - Influence of acetaminophen on indomethacin-treatment of PDA closure; - Influence of acetaminophen on bilirubin glucuronidation ;Primary end point(s): 1 Pharmacokinetic properties of acetaminophen in neonates: safety and efficacy profile Determine optimal loading dose of acetaminophen in different age subgroups Safety outcome parameters are: Acetaminophen serum levels Acetaminophen metabolite levels in urine samples renal function hepatotoxicity( determine NAPQ1 levels as indicator) 2 Pharmacodynamic properties: ComfortNeo score and PIPP as pain assessment tools used in different dose regimens of acetaminophen compared to control groups receiving sucrose | — |
Countries
Netherlands
Outcome results
None listed