Pharmacogenetics Analysis of Fentanyl Administered in Newborns

Launched by IRCCS BURLO GAROFOLO · Apr 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how genetic differences among newborns affect their response to fentanyl, a strong pain reliever often used in Neonatal Intensive Care Units (NICU) for babies on mechanical ventilation. The researchers want to understand why some newborns need different amounts of fentanyl to manage their pain effectively. They believe that certain genes may influence how fentanyl works in the body, which could help doctors provide safer and more effective pain management tailored to each baby’s needs.

To participate in this study, babies must be between 1 to 28 days old and receiving fentanyl while on mechanical ventilation. Parents will need to give written consent for their baby to take part. However, babies who have recently received other opioids or certain medications, have known genetic issues, or are likely to be taken off ventilation quickly will not be eligible. If enrolled, participants may undergo tests to help researchers understand how their genes affect fentanyl's effectiveness and safety. This could lead to better pain management strategies for newborns in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. all newborns on mechanical ventilation receiving fentanyl
• • 2. parental written informed consent for participation in the study must be obtained
• Exclusion Criteria:
• • 1. Concurrent or previous opioid and/or midazolam administration (72 h interval required)
• • 2. Known genetic or chromosomal anomaly
• • 3. Probable rapid extubation