Study of Ketamine Versus Fentanyl as Premedication for Less Invasive Surfactant Administration in Preterm Infants

What this Trial Is About

Researchers are evaluating premedication options for less invasive surfactant administration LISA in preterm infants with surfactant deficiency syndrome. This study aims to find out whether ketamine or fentanyl is more effective and safer for reducing adverse events during the LISA procedure. The trial addresses the need for a suitable premedication that relieves pain without suppressing the infants breathing. Infants requiring LISA will receive premedication including caffeine if under 32 weeks gestational age and not previously given, glycopyrrolate, and either ketamine or fentanyl randomly assigned. The study drugs are given intravenously in specific doses, followed by the LISA procedure performed after five minutes. If needed, doses may be repeated or supplemented with midazolam. The study is randomized, blinded, and includes two treatment groups. Participants are closely monitored during and after the procedure for one hour to assess adverse events, procedure duration, number of catheter insertion attempts, pain scores, additional dosing needs, and respiratory signals. The study collects detailed data on safety and efficacy to determine the better premedication method for this delicate neonatal procedure.

Premedication for Less Invasive Surfactant Administration