ArticleEuropean journal of clinical pharmacology2004
Intravenous paracetamol (propacetamol) pharmacokinetics in term and preterm neonates.
Article in European journal of clinical pharmacology, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 113 citations in OpenAlex.
- [Pediatric perioperative systemic pain therapy: Austrian interdisciplinary recommendations on pediatric perioperative pain management].Schmerz (Berlin, Germany) · 2014Guideline
- Polymorphic Expression of UGT1A9 is Associated with Variable Acetaminophen Glucuronidation in Neonates: A Population Pharmacokinetic and Pharmacogenetic Study.Clinical pharmacokinetics · 2018Trial
- Exposure to acetaminophen and all its metabolites upon 10, 15, and 20 mg/kg intravenous acetaminophen in very-preterm infants.Pediatric research · 2017Trial
- Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates.European journal of pediatrics · 2017Trial
- Neonatal Maturation of Paracetamol (Acetaminophen) Glucuronidation, Sulfation, and Oxidation Based on a Parent-Metabolite Population Pharmacokinetic Model.Clinical pharmacokinetics · 2016Trial
- Developmental changes rather than repeated administration drive paracetamol glucuronidation in neonates and infants.European journal of clinical pharmacology · 2015Trial
- Pharmacokinetics of paracetamol and its metabolites in women at delivery and post-partum.British journal of clinical pharmacology · 2013Trial
- Pharmacological therapy of neonatal analgosedation: current status, dilemmas, and perspectives.Frontiers in pediatrics · 2026Review
- Simultaneous determination of acetaminophen and oxycodone in human plasma by LC-MS/MS and its application to a pharmacokinetic study.Journal of pharmaceutical analysis · 2018Article
- Paracetamol in Patent Ductus Arteriosus Treatment: Efficacious and Safe?BioMed research international · 2017Review
- Intravenous paracetamol for PDA closure in the preterm: a single-center experience.European journal of pediatrics · 2016Observational
- Population Pharmacokinetics of Intravenous Paracetamol (Acetaminophen) in Preterm and Term Neonates: Model Development and External Evaluation.Clinical pharmacokinetics · 2016Article
- Clinical pharmacology of paracetamol in neonates: a review.Current therapeutic research, clinical and experimental · 2015Review
- Prediction of glucuronidated drug clearance in pediatrics (≤5 years): An allometric approach.European journal of drug metabolism and pharmacokinetics · 2015Article
- Pain management in newborns.Clinics in perinatology · 2014Review
- Population pharmacokinetic analysis during the first 2 years of life: an overview.Clinical pharmacokinetics · 2012Review
- Paracetamol serum concentrations in preterm infants treated with paracetamol intravenously: a case series.Journal of medical case reports · 2012Article
- The impact of Caesarean delivery on paracetamol and ketorolac pharmacokinetics: a paired analysis.Journal of biomedicine & biotechnology · 2012Article
- Haemodynamics of intravenous paracetamol in neonates.European journal of clinical pharmacology · 2010Article
- Infant pain management: a developmental neurobiological approach.Nature clinical practice. Neurology · 2009Review
Corrections and comments
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Authors and funding
8 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe aim of this study was to describe propacetamol pharmacokinetics in term and preterm neonates to suggest dosing regimens. METHODS. A population pharmacokinetic analysis of paracetamol (acetaminophen) time-concentration profiles in 48 neonates was undertaken using non-linear mixed-effects models. Neonates were given either single (n=30) or multiple doses (n=18) of propacetamol infusion over 15 min. Neonates had a median postnatal age of 1 day (range, 1-76 days). Median post-conceptual age (PCA) was 35 weeks (range, 27-42 weeks), and median weight was 2.4 kg (range, 0.51-4 kg).
resultsThe population volume of distribution estimate and between-subject variability (%) for a one-compartment model with zero-order input and first-order elimination was 70.4 l (30.7%)/70 kg. Clearance increased from 2.85 l/70 kg, CV 40.7% at 27 weeks PCA to reach 7.05 l/h per 70 kg by 42 weeks PCA (standardised to a 70-kg person using allometric "1/4-power" models). Between-occasion variability for volume of distribution and clearance were 17.4% and 26%, respectively.
conclusionsA mean paracetamol steady-state target concentration above 10 mg/l at trough can be achieved using a loading dose of 40 mg/kg and maintenance doses of 20 mg/kg 6 h in 28-week PCA neonates, 25 mg/kg 6 h at 32 weeks, 30 mg/kg 6 h at 36 weeks and 20 mg/kg 4 h at term (propacetamol doses). Since the role of the oxidative enzyme CYP2E1 and production of the hepatotoxic metabolite N-acetyl-p-benzoquinone-imine still is unknown in premature neonates, lower doses scaled by age-related clearance and centred on a daily dose of 60 mg/kg per day in a child of 6-8 years with a clearance of 0.25 l/h per kg (12.5 l/h per 70 kg) may be more appropriate.
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