Intranasal dexmedetomidine versus intranasal midazolam as a standard of care for pediatric patients undergoing transcatheter perimembranous ventricular septal defect (VSD) closure: a randomized controlled trial.

Abstract

Introduction: Sedative premedication may hold notable significance in pediatric patients undergoing diagnostic and interventional cardiac catheterization, as it minimizes anxiety, facilitates parental separation, and allows for the acceptance of inhalational induction. The intranasal route is a reliable method for administering sedatives as pre- medication in pediatric patients. This study compared and evaluated the sedative effects of intranasal dexmedetomidine versus intranasal midazolam as premedication in pediatric patients undergoing transcatheter closure of ventricular septal defects.

Material and methods: This prospective, randomized, double-blind study included 40 pediatric patients aged 3 to 6 years scheduled for transcatheter perimembranous VSD closure under general anesthesia. The subjects were randomly assigned to receive either intranasal midazolam at 0.2 mg kg^-1 body mass or intranasal dexmedetomidine at 0.5 μg kg^-1 body mass. The primary outcome measured was the effect of preoperative sedatives on the Ramsay sedation score. Secondary outcomes included the child-parent separation score, child emergence agitation level, effects on hemodynamics, and oxygen saturation.

Results: This study included 40 individuals with similar demographic profiles and comparable duration of the procedure (P = 0.152) in both groups. No statistically significant differences were detected in the Ramsay sedation score (P = 0.582), child-parent separation score (P = 1.000) 20 minutes after drug administration, or postoperative child emergence agitation level (P = 0.351). No statistically significant difference was observed in terms of blood pressure, heart rate and oxygen saturation between the two groups.

Conclusions: Pediatric patients were successfully and effectively sedated with both intranasal dexmedetomidine and intranasal midazolam, with stable hemodynamics and oxygen saturation.