ArticlePharmacotherapy2015
Population Pharmacokinetic Model of Sublingual Buprenorphine in Neonatal Abstinence Syndrome.
Article in Pharmacotherapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 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.
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Who cites it
21 citing papers in PubMed, 37 citations in OpenAlex.
- The Pharmacokinetics and Pharmacodynamics of Buprenorphine in Neonatal Abstinence Syndrome.Clinical pharmacology and therapeutics · 2018Trial
- Population pharmacokinetics of exendin-(9-39) and clinical dose selection in patients with congenital hyperinsulinism.British journal of clinical pharmacology · 2018Trial
- Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome.The New England journal of medicine · 2017Trial
- Buprenorphine vs. morphine: impact on neonatal opioid withdrawal syndrome (NOWS) outcomes in a single center retrospective study.Journal of perinatology : official journal of the California Perinatal Association · 2025Article
- Development and Verification of a Full Physiologically Based Pharmacokinetic Model for Sublingual Buprenorphine in Healthy Adult Volunteers that Accounts for Nonlinear Bioavailability.Drug metabolism and disposition: the biological fate of chemicals · 2024Article
- Physiologically-Based Pharmacokinetic Modeling to Investigate the Effect of Maturation on Buprenorphine Pharmacokinetics in Newborns with Neonatal Opioid Withdrawal Syndrome.Clinical pharmacology and therapeutics · 2022Article
- 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
- Using buprenorphine to treat neonatal abstinence syndrome: a quality improvement study.Journal of perinatology : official journal of the California Perinatal Association · 2021Article
- Physiologic Indirect Response Modeling to Describe Buprenorphine Pharmacodynamics in Newborns Treated for Neonatal Opioid Withdrawal Syndrome.Clinical pharmacokinetics · 2021Article
- Pharmacokinetic Characterization and External Evaluation of a Quantitative Framework of Sublingual Buprenorphine in Patients with an Opioid Disorder in Puerto Rico.Pharmaceutics · 2020Article
- Opioids: A Review of Pharmacokinetics and Pharmacodynamics in Neonates, Infants, and Children.European journal of drug metabolism and pharmacokinetics · 2019Review
- Pharmacological and non-pharmacological treatments for the Neonatal Abstinence Syndrome (NAS).Seminars in fetal & neonatal medicine · 2019Review
- Buprenorphine for the Treatment of Neonatal Abstinence Syndrome.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2018Review
- Treating Chronic Pain: An Overview of Clinical Studies Centered on the Buprenorphine Option.Drugs · 2018Review
- Buprenorphine in Neonatal Abstinence Syndrome.Clinical pharmacology and therapeutics · 2018Review
- Naloxone and Metabolites Quantification in Cord Blood of Prenatally Exposed Newborns and Correlations with Maternal Concentrations.AJP reports · 2016Article
- Neonatal abstinence syndrome: Pharmacologic strategies for the mother and infant.Seminars in perinatology · 2016Review
- Influence of Age, Gender and Body Mass Index on Intravenous Pharmacokinetics of Buprenorphine in Children Undergoing Orthopedic Surgery.Dose-response : a publication of International Hormesis SocietyArticle
Corrections and comments
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Authors and funding
7 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveNeonatal abstinence syndrome (NAS)--a clinical entity of infants from in utero exposure to psychoactive xenobiotic and buprenorphine--has been successfully used to treat NAS. However, nothing is known about the pharmacokinetics (PK) of buprenorphine in neonates with NAS. To our knowledge, this is the first study to investigate the population pharmacokinetic of sublingual buprenorphine in neonates with NAS.
designA retrospective population PK analysis of: (1) neonates with NAS treated with sublingual buprenorphine in randomized, double blinded clinical study and (2) data from healthy adults from a previously published pharmacokinetic study.
settingNeonatal intensive care unit and general clinical research unit. PATIENTS: Twenty-four neonates with NAS and five healthy adults.
interventionsAll participants received sublingual buprenorphine per study protocol. MEASUREMENTS AND MAIN
resultsA total of 303 PK data from 29 neonates and adults were used for model development. A population pharmacokinetic analysis was conducted using a first order conditional estimation with interaction in the NONMEM software program. A two-compartment linear PK model with first-order absorption process best described the pharmacokinetics of sublingual buprenorphine in neonates. The apparent clearance (CL) of buprenorphine was linearly related to body weight and matured with increasing age via two distinct saturated pathways. A typical neonate with NAS (body weight, 2.9 kg; postnatal age; 5.4 days) had a CL of 3.5 L/kg/hour and elimination half-life of 11 hours. Phenobarbital did not affect the clearance of buprenorphine compared to neonates of similar age and weight.
conclusionsThis is the first study to investigate the population PK of sublingual buprenorphine in neonatal NAS. To our knowledge, this is also the first report to describe the age-dependent changes of buprenorphine PK in this patient population. No buprenorphine dose adjustment is needed for neonates with NAS treated with buprenorphine and concurrent phenobarbital.
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