Overview
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.
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.).
Eligibility
Inclusion Criteria:
- Neonates \< 45 weeks of corrected gestational age
- Hospitalized in a Neonatal Intensive Care Unit
- Undergoing mechanical ventilation
- Patients that receive morphine alone or morphine and midazolam as continuous infusion
- Affiliated to a social security system
Exclusion Criteria:
- Current weight \< 600g
- Neonates under palliative care
- Therapeutic hypothermia for perinatal anoxia
- Neonates who underwent a surgical procedure during the past 72 hours
- Neonates receiving concomitantly a paralytic or another drug for sedation or analgesia other than morphine or midazolam (except for paracetamol/acetaminophen)
- Parents refusing that their child participate
