A comparative study to assess the efficacy of atomized versus drops administration of intranasal midazolam as premedication in pediatric patients undergoing elective surgery under general anesthesia—A prospective randomized double-blind study

ABSTRACT Background: Preoperative anxiety is one of the major challenges in perioperative care of pediatric surgical patients. Intranasal midazolam is a preferred route of drug administration owing to its ease of administration, non-invasive delivery, and rapid absorption through the highly vascular nasal mucosa, but the method of administration affects the efficacy. Aim: To compare the efficacy of atomized versus drop administration of intranasal midazolam (0.3 mg/kg) as a premedication in pediatric patients aged 2–6 years undergoing elective surgery under general anesthesia. Methods: This prospective double-blind study was conducted in 60 pediatric patients randomly allocated into the Atomized Group or the nasal drops group. Drug acceptance by a 4-point Medicine Acceptance Scale, Sedation, anxiolysis at the time of shifting, assessed by the Parental Separation Anxiety Scale (PSAS), and adverse events. Results: Drug acceptance was superior in the atomized group compared to the nasal drops group (56.7% vs 3.3%; P < 0.001). The atomized group demonstrated statistically significantly higher sedation scores (2.53 ± 0.776 vs. 1.93 ± 0.583; P = 0.001) at 5 mins, indicating faster onset of sedation. PSAS scores were better in the atomized group (1.17 ± 0.592 vs. 1.53 ± 0.629; P = 0.024). Incidence of adverse events was comparable between both groups ( P = 0.379), and no respiratory depression or hemodynamic instability was noted. Conclusion: Atomized intranasal midazolam via mucosal atomization device is superior to conventional nasal drops in achieving higher drug acceptance, faster sedation, and better parental separation anxiolysis in pediatric patients.