Trial reportJournal of clinical pharmacology2017
Population Pharmacokinetics of Dexmedetomidine in Infants.
Trial report in Journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- A systematic review of dexmedetomidine pharmacology in pediatric patients.Clinical and translational science · 2024Pooled it
- Population Modelling of Dexmedetomidine Pharmacokinetics and Haemodynamic Effects After Intravenous and Subcutaneous Administration.Clinical pharmacokinetics · 2020Trial
- Dose rationale and pharmacokinetics of dexmedetomidine in mechanically ventilated new-borns: impact of design optimisation.European journal of clinical pharmacology · 2019Trial
- Analgosedation in Neonatal Intensive Care: Current Strategies, Challenges, and Future Perspectives.Life (Basel, Switzerland) · 2026Review
- Dexmedetomidine Dosing Strategies in Sedation and Anesthesia: Pharmacokinetics, Safety, and Clinical Applications - A Narrative Review.Drug design, development and therapy · 2026Review
- Dexmedetomidine: Shifting Paradigms in Neonatal Sedation and Pain Control.Children (Basel, Switzerland) · 2025Review
- A global cross-sectional survey on neonatal analgosedation: unveiling global trends and challenges through latent class analysis.European journal of pediatrics · 2025Article
- Elucidation of Dexmedetomidine-Induced Analgesic Tolerance Mechanisms in Neuropathic Pain With Modulation of SGK1, NR2A, and NR2B Expression via the Spinal SGK1/NF-κB Signalling Pathway.Journal of cellular and molecular medicine · 2025Article
- Dexmedetomidine for analgesia and sedation for procedural pain or discomfort in newborn infants.The Cochrane database of systematic reviews · 2025Article
- Using Real-World Data to Externally Evaluate Population Pharmacokinetic Models of Dexmedetomidine in Children and Infants.Journal of clinical pharmacology · 2024Article
- Impact of anesthetics on rat hippocampus and neocortex: A comprehensive proteomic study based on label-free mass spectrometry.Heliyon · 2024Article
- The effect of dexmedetomidine on expression of neuronal nitric oxide synthase in spinal dorsal cord in a rat model with chronic neuropathic pain.Arquivos de neuro-psiquiatria · 2023Article
- Dexmedetomidine: An Alternative to Pain Treatment in Neonatology.Children (Basel, Switzerland) · 2023Review
- Population pharmacokinetic analysis of dexmedetomidine in children using real-world data from electronic health records and remnant specimens.British journal of clinical pharmacology · 2022Article
- Pharmacokinetic Pharmacodynamic Modelling Contributions to Improve Paediatric Anaesthesia Practice.Journal of clinical medicine · 2022Review
- A retrospective comparative study of local anesthesia only and local anesthesia with sedation for percutaneous endoscopic lumbar discectomy.Scientific reports · 2022Article
- Best Evidence-Based Dosing Recommendations for Dexmedetomidine for Premedication and Procedural Sedation in Pediatrics: Outcome of a Risk-Benefit Analysis By the Dutch Pediatric Formulary.Paediatric drugs · 2022Article
- Article
- Dexmedetomidine in Children on Extracorporeal Membrane Oxygenation: Pharmacokinetic Data Exploration Using Previously Published Models.Frontiers in pediatrics · 2022Article
- Medication Use in the Neonatal Intensive Care Unit and Changes from 2010 to 2018.The Journal of pediatrics · 2022Article
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 1 country.
Funding
Abstract
Despite limited pharmacokinetic (PK) data, dexmedetomidine is increasingly being used off-label for sedation in infants. We aimed to characterize the developmental PK changes of dexmedetomidine during infancy. In this open-label, single-center PK study of dexmedetomidine in infants receiving dexmedetomidine per clinical care, ≤10 blood samples per infant were collected. A set of structural PK models and residual error models were explored using nonlinear mixed-effects modeling in NONMEM. Covariates including postmenstrual age (PMA), serum creatinine, and recent history of cardiac surgery requiring cardiopulmonary bypass were investigated for their influence on PK parameters. Univariable generalized estimating equation models were used to evaluate the association of hypotension with dexmedetomidine concentrations. A total of 89 PK samples were collected from 20 infants with a median PMA of 44 weeks (range, 33-61). The median maximum dexmedetomidine infusion dose during the study period was 1.8 μg/(kg·h) (0.5-2.5), and 16/20 infants had a maximum dose >1 μg/(kg·h). A 1-compartment model best described the data. Younger PMA was a significant predictor of lower clearance. Infants with a history of cardiac surgery had ∼40% lower clearance compared to those without a history of cardiac surgery. For infants with PMA of 33 to 61 weeks and body weight of 2 to 6 kg, the estimated clearance and volume of distribution were 0.87 to 2.65 L/(kg·h) and 1.5 L/kg, respectively. No significant associations were found between dexmedetomidine concentrations and hypotension. Infants with younger PMA and recent cardiac surgery may require relatively lower doses of dexmedetomidine to achieve exposure similar to older patients and those without cardiac surgery.
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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.