Pharmacokinetics and pharmacodynamics of Acetaminophen in neonates.

Pharmakokinetics and pharmacodynamics of intravenous paracetamol in neonates.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24744

Enrollment

120

Registered

2010-04-12

Start date

2010-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonates, Paracetamol intravenous, Pharmakokinetics, Pharmacodynamics

Interventions

Patients will be randomly allocated to a specific dose regimen of intravenous acetaminophen (10mg/kg, 15 mg/kg or 20 mg/kg) when they need to endure a painful procedure (i.v placement, insertion of a

Eligibility

Inclusion criteria

Inclusion criteria: 1. Neonates (in- and outborn) with a gestational age of 24-42 weeks; 2. Admission within the first 24 hours of life; 3. Indwelling arterial catheter; 4. Painful procedures within the first week of life; 5. Informed consent of the parents or legal guardian.

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies; 2. Intraventriculair haemorrhage > grade 2; 3. Neuromuscular blockers; 4. Absence of an indwelling catheter; 5. Use of morphine, midazolam at start of the study; If patients received more than one loading dose of morphine or midazolam prior to the study or in need of maintenance of any painkiller during the study, they are excluded from participation.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic properties of Acetaminophen in neonates: Safety and Efficacy Profile: Determine optimal loading dose of Acetaminophen in different age-subgroups. 1. Safety outcome parameters are: A. Acetaminophen serum levels; B. Acetaminophen metabolite levels in urine samples; C. Renal function; D. Hepatotoxicity (determine NAPQ1levels as indicator). 2. Pharmacodynamic properties of Acetaminophen in neonates: Comfortneo score and PIPP as pain assessment tools used in the different dose regimens of acetaminophen.	—

Measure

Time frame

Pharmacokinetic properties of Acetaminophen in neonates: Safety and Efficacy Profile: Determine optimal loading dose of Acetaminophen in different age-subgroups. 1. Safety outcome parameters are: A. Acetaminophen serum levels; B. Acetaminophen metabolite levels in urine samples; C. Renal function; D. Hepatotoxicity (determine NAPQ1levels as indicator). 2. Pharmacodynamic properties of Acetaminophen in neonates: Comfortneo score and PIPP as pain assessment tools used in the different dose regimens of acetaminophen.

—

Secondary

Measure	Time frame
Registration and/or drug interaction: 1. Influence of drugs metabolised by cytochrome P-450 on serum levels of acetaminophen: indomethacin; 2. Influence of acetaminophen on indomethacin-treatment of PDA closure; 3. Influence of acetaminophen on bilirubin glucuronidation.	—

Contacts

Public ContactA. Bos

a.bos@erasmusmc.nl+31 (0)10 7036415

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)