Intranasal Dexmedetomidine Versus Midazolam For Pediatric Premedication: Effects on Sedation, Mask Acceptance, and Perioperative Hemodynamic Stability in A Randomized Trial

Abstract

Background: Preoperative anxiety and poor cooperation during anesthesia induction are common challenges in pediatric patients. Intranasal premedication offers a non-invasive approach that may improve sedation, mask acceptance, and perioperative stability. Dexmedetomidine and midazolam are both widely used, although their comparative effects on sedation and hemodynamic responses remain clinically relevant.

Objective: To compare intranasal dexmedetomidine and intranasal midazolam as pediatric premedication with respect to sedation, behaviour during induction, mask acceptance, oxygenation, and perioperative hemodynamic stability.

Materials and Methods: This prospective, randomized, single-blind study included 96 children aged 3–10 years with American Society of Anesthesiologists physical status I or II undergoing elective surgery lasting less than 2 hours. Participants were randomly allocated to two equal groups. Group A received intranasal dexmedetomidine 1 μg/kg and Group B received intranasal midazolam 0.2 mg/kg, approximately 45 minutes before induction. The children and their parents or legal guardians were unaware of the study drug administered.

Results: Baseline characteristics and surgical duration were comparable between groups. Heart rate was significantly lower with dexmedetomidine from 15 minutes after drug administration throughout the intraoperative observations, including at intubation (93.15 ± 5.91 vs 102.52 ± 5.83 beats/min; P<0.0001). Systolic blood pressure was also significantly lower at selected perioperative time points, including intubation (99.60 ± 6.17 vs 104.31 ± 7.39 mmHg; P=0.001). At intubation, the lower sedation score with dexmedetomidine indicated deeper sedation (3.50 ± 0.62 vs 3.92 ± 0.77; P=0.007). Mask-related behaviour was generally acceptable in both groups. At extubation, midazolam produced a more favourable behaviour score (1.85 ± 0.74 vs 2.31 ± 0.99; P=0.020). Oxygen saturation remained satisfactory in both groups, and no adverse events were observed.

Conclusion: Intranasal dexmedetomidine provided a more stable perioperative hemodynamic profile and deeper sedation at induction. Both drugs permitted acceptable mask acceptance, whereas intranasal midazolam showed more favourable behaviour at extubation.