COMPARISON OF INTRANASAL AND ORAL MIDAZOLAM FOR PREMEDICATION IN CHILDREN: A PROSPECTIVE RANDOMIZED STUDY

Abstract

Background: Midazolam is a widely used premedicant in pediatric anesthesia to reduce anxiety and facilitate smooth induction. While both oral and intranasal routes are non-invasive, their onset time, efficacy, and tolerability differ.

Objective: To compare the efficacy, onset of sedation, ease of parental separation, and side effect profile of intranasal midazolam versus oral midazolam in children undergoing elective surgery.

Methods: This prospective, randomized clinical study enrolled 60 children aged 2–8 years, ASA I–II, scheduled for elective surgery under general anesthesia. Participants were randomly assigned to receive intranasal midazolam (0.2 mg/kg) or oral midazolam (0.5 mg/kg) 30 min before induction. Sedation scores, parental separation scores, mask acceptance, and side effects were recorded.

Results: Intranasal midazolam produced a significantly faster onset of sedation (mean: 8.2 ± 2.1 min) compared to oral midazolam (22.5 ± 3.8 min, p < 0.001). At 10 min, adequate sedation was achieved in 86.7% of the intranasal group versus 23.3% of the oral group (p < 0.001). Parental separation scores were superior in the intranasal group. Side effects included mild nasal irritation (20%) in the intranasal group and occasional vomiting (10%) in the oral group. Recovery times were comparable.

Conclusion: Intranasal midazolam provides faster and more effective early sedation than oral midazolam, making it preferable when induction is required soon after premedication. Oral midazolam remains a suitable alternative when there is adequate waiting time and greater focus on patient comfort.