Efficacy and Safety of Nebulized Midazolam versus Oral Midazolam as Sedative Premedication in Pediatric Surgeries.

Abstract

Purpose: To compare the effectiveness of midazolam premedication administered through nebulization and orally as premedication in pediatric anesthesia in ophthalmic surgeries.

Methods: In this randomized controlled double-blind trial, 70 patients scheduled for strabismus surgery were enrolled and divided into two groups. Group O (oral, n = 32) received 0.5 mg/kg oral midazolam and Group N (nebulized, n = 33) received 0.5 mg/kg midazolam through nebulization. Our outcomes included satisfactory sedation of patients, parental separation anxiety, mask acceptance scores, and perioperative hemodynamics up to 30 min postpremedication.

Results: A significant difference in oxygen saturation (SpO₂) at the 30^th min emerged between nebulized and oral midazolam (P = 0.006). Ramsay Sedation scores within 30 min demonstrated comparable sedation levels between Groups N and O. Face mask acceptance scores were excellent in both groups, with no significant differences. Parental separation anxiety scores and the mask acceptance score at the 30^th min revealed no statistically significant differences at various time points (P > 0.05).

Conclusions: In pediatric patients undergoing ophthalmic surgeries, nebulized midazolam is as effective as oral midazolam for sedation. The nebulized form is better tolerated and results in significantly improved SpO₂ levels 30 min after administration. These findings indicate that nebulized midazolam is a safe and effective alternative to oral midazolam for sedative premedication in young children.