Comparison of Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Inguinal and Urological Surgery

What this Trial Is About

Researchers are evaluating the effects of intranasal dexmedetomidine compared to oral midazolam as premedication in children aged 2 to 10 years undergoing elective inguinal and urological surgery under general anesthesia. The study aims to improve preoperative anxiety management, ease parent-child separation, and support cooperation during anesthesia induction. This is a prospective, randomized, double-blind, controlled clinical trial assessing sedation and other perioperative outcomes in pediatric patients. Participants will be randomly assigned to receive either intranasal dexmedetomidine at 2 mcg/kg (max 200 mcg) or oral midazolam at 0.5 mg/kg (max 15 mg) approximately 30 minutes before anesthesia induction. To maintain blinding, each group also receives a placebo via the alternate administration route. Premedication is given prior to anesthesia induction, and clinical parameters are monitored throughout the perioperative period. Children's sedation levels will be assessed about 30 minutes after premedication at anesthesia induction using the Ramsay Sedation Score. Researchers will also measure parent-child separation anxiety, mask acceptance, postoperative emergence agitation, recovery time, and the need for rescue sedation. Vital signs including heart rate, blood pressure, oxygen saturation, and times for extubation and recovery are tracked during surgery and in the post-anesthesia care unit until discharge criteria are met. Participation lasts through the perioperative and immediate postoperative period.

Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery