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

Centre Hospitalier Intercommunal Creteil

Status

Enrolling

Conditions

Sedation Complication

Mechanical Ventilation in Neonates

Treatments

Other: Dose-effect relationship of morphine +/- midazolam administration

Study type

Interventional

Funder types

Other

Identifiers

NCT05371886

PHARAONIC

Details and patient eligibility

About

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.

Full 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.).

Enrollment

180 estimated patients

Sex

All

Ages

20 to 45 weeks old

Volunteers

No Healthy Volunteers

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