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Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care

Sedation Complication Clinical Trial

Official title:
Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care

Clinical Trial Summary

This study aims to describe a dose-effect relationship of morphine alone and morphine and midazolam administered as continuous infusion in neonates hospitalized in Neonatal intensive care unit and undergoing mechanical ventilation, through PKPD modelling.

Clinical Trial Description

This study will include all neonates receiving a sedo-analgesia with continuous infusion of morphine alone or morphine and midazolam during mechanical ventilation in 3 French NICUs. Comfort and pain will be assessed by COMFORTneo pain scores and Newborn Infant Parasympathetic Evaluation Index. Morphine, midazolam and their metabolites' concentrations will be determined on samples taken during a planned blood test. Through PKPD modelling, the dose-concentration-effect relationships will be found and interindividual variability of these drugs in neonates and simulate doses needed to achieve comfort in neonates according to their individual characteristics (gestational age, post-natal age, weight etc.). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05371886
Study type Interventional
Source Centre Hospitalier Intercommunal Creteil
Contact Manon TAUZIN, MD
Phone 01 45 17 50 00
Email manon.tauzin@chicreteil.fr
Status Recruiting
Phase N/A
Start date April 1, 2023
Completion date July 1, 2025
View Details
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