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

Last updated: September 16, 2024
Sponsor: Centre Hospitalier Intercommunal Creteil
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Dose-effect relationship of morphine +/- midazolam administration

Clinical Study ID

NCT05371886
PHARAONIC
  • Ages 20-45
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 continuousinfusion

  • Affiliated to a social security system

Exclusion

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 oranalgesia other than morphine or midazolam (except for paracetamol/acetaminophen)

  • Parents refusing that their child participate

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: Dose-effect relationship of morphine +/- midazolam administration
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
July 01, 2025

Study 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.).

Connect with a study center

  • CHRU Morvan

    Brest, 29609
    France

    Active - Recruiting

  • CH SUD Francilien

    Corbeil-Essonnes, 91100
    France

    Site Not Available

  • CHI Créteil

    Créteil, 94000
    France

    Active - Recruiting

  • CHU Lille

    Lille,
    France

    Site Not Available

  • CHU Tours

    Tours,
    France

    Active - Recruiting

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