Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery

This study aims to compare the effects of intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia. Premedication plays a critical role in reducing preoperative anxiety, facilitating parent-child separation, and improving cooperation during anesthesia induction in pediatric patients. While oral midazolam is widely used, it has several limitations, including variable bioavailability and the risk of paradoxical reactions. Intranasal dexmedetomidine has emerged as a promising alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects. In this prospective, randomized, double-blind, controlled study, patients aged 2-10 years will be assigned to receive either intranasal dexmedetomidine or oral midazolam prior to anesthesia induction. The primary outcome is the proportion of patients achieving adequate sedation at induction, defined as a Ramsay Sedation Score (RSS) ≥2. Secondary outcomes include perioperative hemodynamic stability, parent-child separation anxiety, mask acceptance during induction, postoperative emergence agitation, recovery time, and the need for rescue sedation.

NCT Number	NCT07565116
Lead Sponsor	Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Conditions	Pediatric Anesthesia, Preoperative Anxiety, Emergence Agitation
Enrollment	84 participants
Start Date	2026-05-05
Primary Completion	2026-08-01 (estimated)
Study Completion	2026-09-26 (estimated)
Updated on ClinicalTrials.gov	2026-05-14