Trial reportClinical pharmacology and therapeutics2015
Ondansetron pharmacokinetics in pregnant women and neonates: towards a new treatment for neonatal abstinence syndrome.
Trial report in Clinical pharmacology and therapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01801475 (Prevention of Neonatal Abstinence Syndrome), which is not on this map. Cited by 17 papers, 3 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.
Prevention of Neonatal Abstinence Syndrome
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Development of a Generic Physiologically-Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk.Clinical pharmacology and therapeutics · 2022Pooled it
- Single-dose of ondansetron for vomiting in children and adolescents with acute gastroenteritis-an updated systematic review and meta-analysis.European journal of pediatrics · 2020Pooled it
- Pregnancy-Associated Changes in Pharmacokinetics: A Systematic Review.PLoS medicine · 2016Pooled it
- Bayesian Population Pharmacokinetic Modeling of Ondansetron for Neonatal Opioid Withdrawal Syndrome.Clinical and translational science · 2025Trial
- 5-HTP inhibits eosinophilia via intracellular endothelial 5-HTRs; SNPs in 5-HTRs associate with asthmatic lung function.Frontiers in allergy · 2024Article
- A Physiologically Based Pharmacokinetic Model to Predict Systemic Ondansetron Concentration in Liver Cirrhosis Patients.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Optimizing a therapy for opiate use disorders: Characterizing ondansetron pharmacokinetics in blood and brain.Clinical and translational science · 2023Article
- Mechanistic Modeling of Placental Drug Transfer in Humans: How Do Differences in Maternal/Fetal Fraction of Unbound Drug and Placental Influx/Efflux Transfer Rates Affect Fetal Pharmacokinetics?Frontiers in pediatrics · 2021Article
- What Have We Learned (or Expect to) From Analysis of Murine Genetic Models Related to Substance Use Disorders?Frontiers in psychiatry · 2021Review
- Article
- PharmGKB summary: Ondansetron and tropisetron pathways, pharmacokinetics and pharmacodynamics.Pharmacogenetics and genomics · 2019Article
- A Physiologically Based Pharmacokinetic Model for Pregnant Women to Predict the Pharmacokinetics of Drugs Metabolized Via Several Enzymatic Pathways.Clinical pharmacokinetics · 2018Article
- Preferential Delivery of an Opioid Antagonist to the Fetal Brain in Pregnant Mice.The Journal of pharmacology and experimental therapeutics · 2016Article
- Neonatal abstinence syndrome: Pharmacologic strategies for the mother and infant.Seminars in perinatology · 2016Review
- Bringing attention to a need for a standardized treatment and weaning protocol for neonatal abstinence syndrome.Translational pediatrics · 2016Article
- Long-Acting Opioids for Treating Neonatal Abstinence Syndrome: A High Price for a Short Stay?JAMA · 2015Article
- The role of 5-HT modulation in opioid withdrawal and neonatal opioid withdrawal syndrome: mechanisms and potential serotonergic targets.Expert opinion on investigational drugsReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 3 countries.
Funding
Abstract
Ondansetron is the drug of choice to prevent nausea in women undergoing cesarean surgery and can be used to prevent neonatal abstinence syndrome (NAS). The pharmacokinetics of ondansetron have not been characterized in pregnant women or in newborns. A nonlinear mixed-effects modeling approach was used to analyze plasma samples obtained from 20 nonpregnant and 40 pregnant women following a single administration of 4 or 8 mg ondansetron, from umbilical cord blood at delivery, and from neonates after birth. The analysis indicates that: ondansetron disposition is not affected by pregnancy (P > 0.05), but influenced by dose (P < 0.05), and is characterized by rapid transplacental transfer and longer elimination half-life in neonates compared to their mother. A dosing regimen for prevention of NAS was designed based on the model. The regimen involves IV administration of 4 mg to the mothers shortly before cord clamping, or oral administration of 0.07 mg/kg (or equivalently 0.04 mg/kg IV) to neonates.
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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.