Trial reportClinical pharmacokinetics2016
Neonatal Maturation of Paracetamol (Acetaminophen) Glucuronidation, Sulfation, and Oxidation Based on a Parent-Metabolite Population Pharmacokinetic Model.
Trial report in Clinical pharmacokinetics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01328808 (Metabolism and Toxicity of Acetaminophen in Preterm Infants), which is not on this map. Cited by 23 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Metabolism and Toxicity of Acetaminophen in Preterm Infants
Who cites it
23 citing papers in PubMed, 54 citations in OpenAlex.
- Trial
- Pharmacokinetics of morphine in encephalopathic neonates treated with therapeutic hypothermia.PloS one · 2019Trial
- 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
- NAPQI adducts in patients with selective hypersensitivity to acetaminophen.Frontiers in pharmacology · 2026Article
- Pharmacological therapy of neonatal analgosedation: current status, dilemmas, and perspectives.Frontiers in pediatrics · 2026Review
- A Novel Maturation Equation for Hepatic Clearance Across Preterm, Term Neonates, Children, and Adults: Application to Paracetamol and Its Metabolite.Journal of clinical pharmacology · 2025Article
- Population Pharmacokinetics of Intravenous Paracetamol and Its Metabolites in Extreme Preterm Neonates in the Context of Patent Ductus Arteriosus Treatment.Clinical pharmacokinetics · 2024Article
- When will the Glomerular Filtration Rate in Former Preterm Neonates Catch up with Their Term Peers?Pharmaceutical research · 2024Article
- Acetaminophen causes neurodevelopmental injury in susceptible babies and children: no valid rationale for controversy.Clinical and experimental pediatrics · 2024Article
- Challenges of pediatric pharmacotherapy: A narrative review of pharmacokinetics, pharmacodynamics, and pharmacogenetics.European journal of clinical pharmacology · 2024Review
- The Dangers of Acetaminophen for Neurodevelopment Outweigh Scant Evidence for Long-Term Benefits.Children (Basel, Switzerland) · 2023Review
- Maturation of Paracetamol Elimination Routes in Preterm Neonates Born Below 32 Weeks of Gestation.Pharmaceutical research · 2023Article
- Pharmacokinetics of acetaminophen after a single Oral administration of 20 or 40 mg/kg to 7-9 Day-old foals.Frontiers in veterinary science · 2023Article
- Current knowledge, challenges and innovations in developmental pharmacology: A combined conect4children Expert Group and European Society for Developmental, Perinatal and Paediatric Pharmacology White Paper.British journal of clinical pharmacology · 2022Review
- The Blind Spot of Pharmacology: A Scoping Review of Drug Metabolism in Prematurely Born Children.Frontiers in pharmacology · 2022Article
- Pediatric Palliative Care Pharmacy Pearls-A Focus on Pain and Sedation.Children (Basel, Switzerland) · 2021Article
- A Critical Review on the Relevance of Paracetamol for Procedural Pain Management in Neonates.Frontiers in pediatrics · 2020Review
- Ontogeny of Hepatic Sulfotransferases and Prediction of Age-Dependent Fractional Contribution of Sulfation in Acetaminophen Metabolism.Drug metabolism and disposition: the biological fate of chemicals · 2019Article
- Interventional cohort study of prolonged use (>72 hours) of paracetamol in neonates: protocol of the PARASHUTE study.BMJ paediatrics open · 2019Article
Corrections and comments
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Authors and funding
9 authors at 4 institutions in 4 countries.
Funding
Abstract
objectivesThis study aimed to model the population pharmacokinetics of intravenous paracetamol and its major metabolites in neonates and to identify influential patient characteristics, especially those affecting the formation clearance (CL
methodsNeonates with a clinical indication for intravenous analgesia received five 15-mg/kg doses of paracetamol at 12-h intervals (<28 weeks' gestation) or seven 15-mg/kg doses at 8-h intervals (≥28 weeks' gestation). Plasma and urine were sampled throughout the 72-h study period. Concentration-time data for paracetamol, paracetamol-glucuronide, paracetamol-sulfate, and the combined oxidative pathway metabolites (paracetamol-cysteine and paracetamol-N-acetylcysteine) were simultaneously modeled in NONMEM 7.2.
resultsThe model incorporated 259 plasma and 350 urine samples from 35 neonates with a mean gestational age of 33.6 weeks (standard deviation 6.6). CL
conclusionsThe parent-metabolite model successfully characterized the pharmacokinetics of intravenous paracetamol and its metabolites in neonates. Maturational changes in the fraction of paracetamol undergoing oxidation were small relative to between-subject variability.
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