A Novel Application of the Volumetric Absorptive Micro Sampling Strategy to Quantify Dexmedetomidine in Capillary Blood Using an LC-MS/MS Method.
4 affiliations
- 1Department of Comparative Biomedicine and Food Science, University of Padova, Legnaro, PD, Italy.
- 2Department of Advanced Translational Diagnostics, Institute for Maternal and Child Health, IRCCS "Burlo Garofolo", Trieste, Italy.
- 3Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy.
- 4Neonatal Intensive Care Unit, Institute for Maternal and Child Health IRCCS "Burlo Garofolo", Trieste, Italy.
Abstract
Background
Pain control in neonates is crucial as inadequate management may impair neuronal development. Dexmedetomidine (DEX), an alpha2 agonist, is approved for intravenous use in ventilated neonates. While intranasal DEX is off-label in neonates and children, studies show its efficacy for magnetic resonance imaging sedation. Limited pharmacokinetic data exist for intranasal DEX in pre-term infants and neonates. This study aimed to develop an analytical method for DEX quantification in blood samples (20 μL) of complex patients collected with microsampling technique to enable future pharmacokinetic studies.Methods
A liquid-liquid extraction from blood absorbed in microsampling devices (MITRA) and an LC-MS/MS method were developed and validated following EMA/FDA guidelines. The method's suitability was verified by comparing results from nine paediatric blood samples collected in EDTA tubes or using MITRA devices.Results
All results obtained for selectivity (no interference at RT of DEX), sensitivity (DEX LLOQ = 0.025 ng/mL), linearity (R² > 0.99), intra and inter-day repeatability (CV % 1.8-11.8), stability, and hematocrit effect met the acceptance criteria for bioanalytical method validation. Compared with plasma samples, the proposed method showed good consistency in detecting DEX in MITRA samples.Conclusion
The MITRA microsampling tools reduce the amount of blood needed and the risks of anemisation for neonates hospitalised and simplifies procedures, allowing a reduction of the staff involved in the routine. The analytical and clinical validation of the method demonstrated its suitability to quantify DEX in a range of concentrations potentially useful for pharmacokinetic studies in paediatric patients for approval use and drug monitoring.
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BibTeX
@article{lucatello2026novel,
title = {{A Novel Application of the Volumetric Absorptive Micro Sampling Strategy to Quantify Dexmedetomidine in Capillary Blood Using an LC-MS/MS Method.}},
author = {Lorena Lucatello and Martina Franzin and Gabriele Stocco and Jenny Bua and Francesca Cossovel and Riccardo Addobbati and Francesca Capolongo},
journal = {Journal of clinical laboratory analysis},
year = {2026},
month = oct,
doi = {10.1002/jcla.70387},
url = {https://europepmc.org/article/MED/42920351},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - A Novel Application of the Volumetric Absorptive Micro Sampling Strategy to Quantify Dexmedetomidine in Capillary Blood Using an LC-MS/MS Method.
AU - Lorena Lucatello
AU - Martina Franzin
AU - Gabriele Stocco
AU - Jenny Bua
AU - Francesca Cossovel
AU - Riccardo Addobbati
AU - Francesca Capolongo
PY - 2026
DA - 2026/10/24
JO - Journal of clinical laboratory analysis
DO - 10.1002/jcla.70387
UR - https://europepmc.org/article/MED/42920351
AB - Background Pain control in neonates is crucial as inadequate management may impair neuronal development. Dexmedetomidine (DEX), an alpha2 agonist, is approved for intravenous use in ventilated neonates. While intranasal DEX is off-label in neonates and children, studies show its efficacy for magnetic resonance imaging sedation. Limited pharmacokinetic data exist for intranasal DEX in pre-term infants and neonates. This study aimed to develop an analytical method for DEX quantification in blood samples (20 μL) of complex patients collected with microsampling technique to enable future pharmacokinetic studies.Methods A liquid-liquid extraction from blood absorbed in microsampling devices (MITRA) and an LC-MS/MS method were developed and validated following EMA/FDA guidelines. The method's suitability was verified by comparing results from nine paediatric blood samples collected in EDTA tubes or using MITRA devices.Results All results obtained for selectivity (no interference at RT of DEX), sensitivity (DEX LLOQ = 0.025 ng/mL), linearity (R² > 0.99), intra and inter-day repeatability (CV % 1.8-11.8), stability, and hematocrit effect met the acceptance criteria for bioanalytical method validation. Compared with plasma samples, the proposed method showed good consistency in detecting DEX in MITRA samples.Conclusion The MITRA microsampling tools reduce the amount of blood needed and the risks of anemisation for neonates hospitalised and simplifies procedures, allowing a reduction of the staff involved in the routine. The analytical and clinical validation of the method demonstrated its suitability to quantify DEX in a range of concentrations potentially useful for pharmacokinetic studies in paediatric patients for approval use and drug monitoring.
SN - 0887-8013
SN - 1098-2825
ER -