ArticleAnesthesiology research and practice2020
Dexmedetomidine Pharmacokinetics in Neonates with Hypoxic-Ischemic Encephalopathy Receiving Hypothermia.
Article in Anesthesiology research and practice, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06985290 (Comparative Efficacy of Dexmedetomidine Versus Morphine in Alleviating Secondary Brain Injury, When Used for Sedation During Hypothermia Therapy in Neonates), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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.
Comparative Efficacy of Dexmedetomidine Versus Morphine in Alleviating Secondary Brain Injury, When Used for Sedation During Hypothermia Therapy in Neonates: A Pilot Randomized Trial
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.
- A systematic review of dexmedetomidine pharmacology in pediatric patients.Clinical and translational science · 2024Pooled it
- Analgesia and sedation trends in a level IV NICU, 2014-2024: Opioid and dexmedetomidine use.Journal of perinatology : official journal of the California Perinatal Association · 2026Article
- Dexmedetomidine for LISA procedure: a prospective observational single center experience.Italian journal of pediatrics · 2026Observational
- Sedation and Pain Management in Neonates Undergoing Therapeutic Hypothermia for Hypoxic-Ischemic Encephalopathy.Children (Basel, Switzerland) · 2025Review
- Efficacy of opioid-free anesthesia in short-term recovery following laparoscopic-assisted colorectal tumor resection: a randomized trial.Frontiers in oncology · 2025Article
- Oral Clonidine-Based Strategy to Reduce Opiate Use During Cooling for Neonatal Encephalopathy: An Observational Study.The Journal of pediatrics · 2024Observational
- Using Real-World Data to Externally Evaluate Population Pharmacokinetic Models of Dexmedetomidine in Children and Infants.Journal of clinical pharmacology · 2024Article
- Effectiveness and Safety of Dexmedetomidine in Neonates With Hypoxic Ischemic Encephalopathy Undergoing Therapeutic Hypothermia.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024Article
- Predicting Volume of Distribution in Neonates: Performance of Physiologically Based Pharmacokinetic Modelling.Pharmaceutics · 2023Article
- Dexmedetomidine: An Alternative to Pain Treatment in Neonatology.Children (Basel, Switzerland) · 2023Review
- Analgesia and sedation strategies in neonates undergoing whole-body therapeutic hypothermia: A scoping review.PloS one · 2023Article
- Adequacy of sedation analgesia to support the comfort of neonates undergoing therapeutic hypothermia and its impact on short-term neonatal outcomes.Frontiers in pediatrics · 2023Article
- Sedation and analgesia from prolonged pain and stress during mechanical ventilation in preterm infants: is dexmedetomidine an alternative to current practice?BMJ paediatrics open · 2022Review
- Dexmedetomidine versus intermittent morphine for sedation of neonates with encephalopathy undergoing therapeutic hypothermia.Journal of perinatology : official journal of the California Perinatal Association · 2021Observational
- Management of comfort and sedation in neonates with neonatal encephalopathy treated with therapeutic hypothermia.Seminars in fetal & neonatal medicine · 2021Review
- Emerging therapies and management for neonatal encephalopathy-controversies and current approaches.Journal of perinatology : official journal of the California Perinatal Association · 2021Review
- Off-label use of dexmedetomidine in paediatric anaesthesiology: an international survey of 791 (paediatric) anaesthesiologists.European journal of clinical pharmacology · 2021Article
- Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial): A Randomized Controlled Trial: Background, Aims and Study Protocol.Frontiers in pain research (Lausanne, Switzerland) · 2021Article
Corrections and comments
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Authors and funding
5 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Dexmedetomidine is a promising sedative and analgesic for newborns with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia (TH). Pharmacokinetics and safety of dexmedetomidine were evaluated in a phase I, single-center, open-label study to inform future trial strategies. We recruited 7 neonates ≥36 weeks' gestational age diagnosed with moderate-to-severe HIE, who received a continuous dexmedetomidine infusion during TH and the 6 h rewarming period. Time course of plasma dexmedetomidine concentration was characterized by serial blood sampling during and after the 64.8 ± 6.9 hours of infusion. Noncompartmental analysis yielded descriptive pharmacokinetic estimates: plasma clearance of 0.760 ± 0.155 L/h/kg, steady-state distribution volume of 5.22 ± 2.62 L/kg, and mean residence time of 6.84 ± 3.20 h. Naive pooled and population analyses according to a one-compartment model provided similar estimates of clearance and distribution volume. Overall, clearance was either comparable or lower, distribution volume was larger, and mean residence time or elimination half-life was longer in cooled newborns with HIE compared to corresponding estimates previously reported for uncooled (normothermic) newborns without HIE at comparable gestational and postmenstrual ages. As a result, plasma concentrations in cooled newborns with HIE rose more slowly in the initial hours of infusion compared to predicted concentration-time profiles based on reported pharmacokinetic parameters in normothermic newborns without HIE, while similar steady-state levels were achieved. No acute adverse events were associated with dexmedetomidine treatment. While dexmedetomidine appeared safe for neonates with HIE during TH at infusion doses up to 0.4
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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.