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

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.

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.

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.

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.

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.