ArticleThe journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG2011
Safety and population pharmacokinetic analysis of intravenous acetaminophen in neonates, infants, children, and adolescents with pain or Fever.
Article in The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03192566 (The Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Obese Children and Adolescents), which is not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
The Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Obese Children and Adolescents
Who cites it
31 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.
- Paracetamol (acetaminophen) use in infants and children was never shown to be safe for neurodevelopment: a systematic review with citation tracking.European journal of pediatrics · 2022Pooled it
- Comparison of preemptive and preventive intravenous acetaminophen on opioid consumption in pediatrics undergoing posterior spinal fusion surgery: a randomized controlled trial.Korean journal of anesthesiology · 2024Trial
- Randomized Population Pharmacokinetic Analysis and Safety of Intravenous Acetaminophen for Acute Postoperative Pain in Neonates and Infants.Journal of clinical pharmacology · 2020Trial
- Successful Use of [Clinical pharmacokinetics · 2017Trial
- Neonatal Maturation of Paracetamol (Acetaminophen) Glucuronidation, Sulfation, and Oxidation Based on a Parent-Metabolite Population Pharmacokinetic Model.Clinical pharmacokinetics · 2016Trial
- Acute postoperative pain control in pediatric patients: a scoping review.Journal of Yeungnam medical science · 2026Article
- 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
- Article
- PBPK Modeling of Acetaminophen in Pediatric Populations: Incorporation of SULT Enzyme Ontogeny to Predict Age-Dependent Metabolism and Systemic Exposure.Life (Basel, Switzerland) · 2025Article
- Fentanyl in neonates, a population pharmacokinetic, -genetic and -dynamic study.Pediatric research · 2025Article
- Clinical Toxicology of OTC Cough and Cold Pediatric Medications: A Narrative Review.Pediatric health, medicine and therapeutics · 2024Review
- The Three W's of Acetaminophen In Children: Who, Why, and Which Administration Mode.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023Article
- Management of acute fever in children: Consensus recommendations for community and primary healthcare providers in sub-Saharan Africa.African journal of emergency medicine : Revue africaine de la medecine d'urgence · 2021Review
- Postoperative Pain Management in Pediatric Spinal Fusion Surgery for Idiopathic Scoliosis.Paediatric drugs · 2020Review
- Successful Extrapolation of Paracetamol Exposure from Adults to Infants After Oral Administration of a Pediatric Aqueous Suspension Is Highly Dependent on the Study Dosing Conditions.The AAPS journal · 2020Article
- Population Pharmacokinetic Modeling of Acetaminophen Protein Adducts in Adults and Children.Journal of clinical pharmacology · 2020Article
- Phase I Pharmacokinetic Study of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in Healthy Adult and Adolescent Populations.Drugs in R&D · 2020Article
- 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
- Population Pharmacokinetic Modeling of Acetaminophen and Metabolites in Children After Cardiac Surgery With Cardiopulmonary Bypass.Journal of clinical pharmacology · 2019Observational
- Genetics of the patent ductus arteriosus (PDA) and pharmacogenetics of PDA treatment.Seminars in fetal & neonatal medicine · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe administration of acetaminophen via the oral and rectal routes may be contraindicated in specific clinical settings. Intravenous administration provides an alternative route for fever reduction and analgesia. This phase 1 study of intravenous acetaminophen (Ofirmev, Cadence Pharmaceuticals, Inc., San Diego, CA) in inpatient pediatric patients with pain or fever requiring intravenous therapy was designed to assess the safety and pharmacokinetics of repeated doses over 48 hours.
methodsNeonates (full-term to 28 days) received either 12.5 mg/kg every 6 hours or 15 mg/kg every 8 hours. Infants (29 days to <2 years), children (2 to <12 years) and adolescents (≥12 years) received either 12.5 mg/kg every 4 hours or 15 mg/kg every 6 hours. Both noncompartmental and population nonlinear mixed-effects modeling approaches were used. Urinary metabolite data were analyzed, and safety and tolerability were assessed.
resultsPharmacokinetic parameters of acetaminophen were estimated using a two-compartment disposition model with weight allometrically expressed on clearances and central and peripheral volumes of distribution (Vds). Postnatal age, with a maturation function, was a significant covariate on clearance. Total systemic normalized clearance was 18.4 L/hr per 70 kg, with a plateau reached at approximately 2 years. Total central and peripheral Vds of acetaminophen were 16 and 59.5 L/70 kg, respectively. The drug was well tolerated based on the incidence of adverse events. The primary and minor pathways of elimination were acetaminophen glucuronidation, sulfation, and glutathione conjugate metabolites across all age groups.
conclusionsIntravenous acetaminophen in infants, children, and adolescents was well tolerated and achieved plasma concentrations similar to those achieved with labeled 15 mg/kg body weight doses by oral or rectal administration.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.