Trial reportJournal of clinical pharmacology2016
Mechanistic Population Pharmacokinetics of Morphine in Neonates With Abstinence Syndrome After Oral Administration of Diluted Tincture of Opium.
Trial report in Journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Sedatives for opioid withdrawal in newborn infants.The Cochrane database of systematic reviews · 2021Pooled it
- Therapeutic approaches for neonatal abstinence syndrome: a systematic review of randomized clinical trials.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2019Pooled it
- Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial.Lancet (London, England) · 2018Trial
- Codeine and Metabolite Concentrations in the Breastfed Neonate.Paediatric anaesthesia · 2026Review
- Article
- Scoping Review of Paediatric Population Pharmacokinetic Models of Morphine.Clinical pharmacokinetics · 2025Article
- Fetal and Infant Effects of Maternal Opioid Use during Pregnancy: A Literature Review including Clinical, Toxicological, Pharmacogenomic, and Epigenetic Aspects for Forensic Evaluation.Children (Basel, Switzerland) · 2024Review
- The MILK study: Investigating intergenerational transmission of low-calorie sweeteners in breast milk.Contemporary clinical trials communications · 2023Article
- Predicting Maternal and Infant Tetrahydrocannabinol Exposure in Lactating Cannabis Users: A Physiologically Based Pharmacokinetic Modeling Approach.Pharmaceutics · 2023Article
- Population Pharmacokinetic Analysis of Follicle-Stimulating Hormone During Ovarian Stimulation: Relation with Weight, Prolactin and Gene Polymorphism in THADA and ADIPOQ.Clinical pharmacokinetics · 2023Article
- Systematic Review and Meta-Analysis of the Effect of Loop Diuretics on Antibiotic Pharmacokinetics.Pharmaceutics · 2023Review
- Hydromorphone Prescription for Pain in Children-What Place in Clinical Practice?Frontiers in pediatrics · 2022Review
- Pharmacometric dose optimization of buprenorphine in neonatal opioid withdrawal syndrome.Clinical and translational science · 2021Article
- Pediatric Palliative Care Pharmacy Pearls-A Focus on Pain and Sedation.Children (Basel, Switzerland) · 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
- Physiologically based pharmacokinetic/pharmacodynamic model for the prediction of morphine brain disposition and analgesia in adults and children.PLoS computational biology · 2021Article
- Population Pharmacokinetics of Tapentadol in Children from Birth to <18 Years Old.Journal of pain research · 2020Article
- Continuous intravenous to oral morphine switch in very premature ventilated infants: A retrospective study on efficacy, efficiency, and tolerability.Paediatric & neonatal pain · 2019Article
- Opioids: A Review of Pharmacokinetics and Pharmacodynamics in Neonates, Infants, and Children.European journal of drug metabolism and pharmacokinetics · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
Abstract
Conducting and analyzing clinical trials in vulnerable neonates are extremely challenging. The aim of this analysis is to develop a morphine population pharmacokinetics (PK) model using data collected during a randomized control trial in neonates with abstinence syndrome (NAS). A 3-compartment morphine structural PK model after intravenous (IV) administration from previously published work was utilized as prior, whereas an allometric scaling method with physiological consideration was used to extrapolate a PK profile from adults to pediatrics. The absorption rate constant and bioavailability were estimated in NAS after oral administration of diluted tincture of opium (DTO). Goodness-of-fit plots along with normalized prediction distribution error and bootstrap method were performed for model evaluation. We successfully extrapolated the PK profile from adults to pediatrics after IV administration. The estimated first-order absorption rate constant and bioavailability were 0.751 hour(-1) and 48.5%, respectively. Model evaluations showed that the model can accurately and precisely describe the observed data. The population pharmacokinetic model we derived for morphine after oral administration of DTO is reasonable and acceptable; therefore, it can be used to describe the PK and guide future studies. The integration of the previous population PK knowledge as prior information successfully overcomes the logistic and practical issue in vulnerable neonate population.
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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.