Trial reportThe Journal of pediatrics2015
Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome: A Pilot Study.
Trial report in The Journal of pediatrics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01754324 (The Utility and Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome in Neonates), which is not on this map. Cited by 26 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 Utility and Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome in Neonates
Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.
- Opioid treatment for opioid withdrawal in newborn infants.The Cochrane database of systematic reviews · 2021Pooled it
- Accelerated Weaning of Opioids to Reduce Pharmacologic Exposure for Neonatal Opioid Withdrawal Syndrome: A Randomized Clinical Trial.The Journal of pediatrics · 2026Trial
- Pharmacokinetic Modeling and Model-Based Hypothesis Generation for Dose Optimization of Clonidine in Neonates With Neonatal Opioid Withdrawal Syndrome.Clinical pharmacology and therapeutics · 2025Trial
- Trial
- Developmental Pharmacokinetics and Age-Appropriate Dosing Design of Milrinone in Neonates and Infants with Acute Kidney Injury Following Cardiac Surgery.Clinical pharmacokinetics · 2019Trial
- Comparison of Safety and Efficacy of Methadone vs Morphine for Treatment of Neonatal Abstinence Syndrome: A Randomized Clinical Trial.JAMA pediatrics · 2018Trial
- A Scoping Review of Non-Opioid Therapeutics for Opioid Withdrawal: Translational Relevance to Neonatal Opioid Withdrawal Syndrome (NOWS) Research.Clinical and translational science · 2026Article
- Article
- A Systematic Review of Clinical Practice Guidelines for Neonatal Abstinence Syndrome.Children (Basel, Switzerland) · 2023Review
- Potential problems and solutions of opioid-based treatment in neonatal opioid withdrawal syndrome (NOWS): a scoping review protocol.BMJ open · 2023Article
- Pharmacometric dose optimization of buprenorphine in neonatal opioid withdrawal syndrome.Clinical and translational science · 2021Article
- Integrated Review of the Assessment of Newborns With Neonatal Abstinence Syndrome.Journal of obstetric, gynecologic, and neonatal nursing : JOGNN · 2021Review
- Clinical pharmacology and dosing regimen optimization of neonatal opioid withdrawal syndrome treatments.Clinical and translational science · 2021Review
- Pharmacometric Evaluation of Umbilical Cord Blood Concentration-Based Early Initiation of Treatment in Methadone-Exposed Preterm Neonates.Children (Basel, Switzerland) · 2021Article
- Physiologic Indirect Response Modeling to Describe Buprenorphine Pharmacodynamics in Newborns Treated for Neonatal Opioid Withdrawal Syndrome.Clinical pharmacokinetics · 2021Article
- Utilizing Pediatric Physiologically Based Pharmacokinetic Models to Examine Factors That Contribute to Methadone Pharmacokinetic Variability in Neonatal Abstinence Syndrome Patients.Journal of clinical pharmacology · 2020Article
- Electronic Health Record-Embedded Decision Support Platform for Morphine Precision Dosing in Neonates.Clinical pharmacology and therapeutics · 2020Article
- Buprenorphine pharmacotherapy for the management of neonatal abstinence syndrome in methadone-exposed neonates.Paediatric & neonatal pain · 2019Article
- Opioids: A Review of Pharmacokinetics and Pharmacodynamics in Neonates, Infants, and Children.European journal of drug metabolism and pharmacokinetics · 2019Review
- Comprehensive Perioperative Management Considerations in Patients Taking Methadone.Current pain and headache reports · 2019Review
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveTo characterize the population pharmacokinetics of oral methadone in neonates requiring pharmacologic treatment of neonatal abstinence syndrome and to develop a pharmacokinetic (PK) model toward an evidence-based treatment protocol. STUDY
designBased on a methadone dosing protocol, serum concentrations of methadone and its metabolites were assessed by high performance liquid chromatography-tandem mass spectrometry from dried blood spots. Population PK analysis was performed to determine the volume of distribution and clearance of oral methadone. Methadone plasma concentration-time profiles were simulated from the deduced PK model to optimize the dosing regimen.
resultsThere was substantial interindividual variability in methadone concentrations. Blood concentrations of methadone were best described by a 1-compartment model with first-order absorption. The population mean estimates (coefficient of variation percentage) for oral clearance and volume of distribution were 8.94 (103%) L/h/70 kg and 177 (133%) L/70 kg, respectively. Optimized dosing strategies were developed based on the simulated PK profiles. We suggest a starting dose of 0.1 mg/kg per dose every 6 hours for most patients requiring pharmacologic treatment of neonatal abstinence syndrome followed by an expedited weaning phase.
conclusionsThe proposed dosing regimen may reduce the cumulative dose of opioid and shorten the length of hospitalization. Future studies should aim to validate the simulated dosing schemes with clinical data and expand our understanding of the between-patient PK variability.
trial registrationClinicalTrials.gov: NCT01754324.
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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.