Comparative Analysis of Intranasal Midazolam versus Dexmedetomidine as Paediatric Premedication: Impact on Sedation, Anxiolysis, Mask Acceptance, Procedure Response, Hemodynamic Stability, and Postoperative Agitation

This prospective, randomized, comparative study aims to evaluate and compare the efficacy and safety of intranasal dexmedetomidine and intranasal midazolam as premedication in paediatric patients aged 4 to 10 years (ASA I to II) undergoing elective surgeries under general anaesthesia. Eighty children will be randomly allocated into two groups Group M intranasal midazolam 0.2 mg per kg and Group D intranasal dexmedetomidine 1 µg per kg, administered 30 minutes before induction.

The primary outcome is sedation score assessed at 15 and 30 minutes post-administration. Secondary outcomes include anxiolysis at parental separation, venipuncture response, mask acceptance, postoperative agitation, and hemodynamic parameters HR, BP, SpO2. The study hypothesizes that intranasal dexmedetomidine will provide superior sedation quality and improved procedural cooperation with comparable safety profile compared to midazolam