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

Launched by CENTRE HOSPITALIER INTERCOMMUNAL CRETEIL · May 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how morphine, a medication used for pain relief, works in newborns who need help breathing through a machine called mechanical ventilation. The researchers want to understand how the effects of morphine change when it is given alone or together with another medication called midazolam, which is used for sedation. The goal is to find the right doses that safely help these tiny patients feel comfortable while they are in the hospital.

To be eligible for this trial, newborns must be less than 45 weeks old in terms of their development and currently hospitalized in a Neonatal Intensive Care Unit while on mechanical ventilation. The study will include babies who are receiving either morphine by itself or morphine along with midazolam. However, babies weighing less than 600 grams, those in palliative care, or who have had recent surgeries are not able to participate. If families agree to join, they can expect to contribute to important research that may improve the care of future newborns needing similar treatments.

Gender

ALL

Eligibility criteria

• 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