Comparison of Intranasal Ketamine versus Oral Midazolam as Pre-Anesthetic Agents with Nitrous Oxide in Pediatric Patients Undergoing Ophthalmic Examination under Anesthesia

Abstract

Background: The administration of sedative agents before surgery offers numerous advantages, particularly in pediatric patients. Due to the limitations of existing studies, this study sought to assess the comparative effectiveness of intranasal ketamine and oral midazolam in terms of their sedative properties and impact on vital signs during eye examinations conducted under anesthesia. Methods: Patients in the ketamine group received intranasal ketamine at a dose of 5 mg/kg, while those in the midazolam group were given oral midazolam at a dose of 0.3 mg/kg. Placebo groups received normal saline via intranasal or oral routes accordingly. Patients underwent the procedure while sedated with nitrous oxide. Patient status was assessed at various time points around the procedure. Findings: Thirty participants, with a mean age of (4.10 ± 1.13) years, were enrolled in this study. No significant difference was observed in the mean recovery time (25.36 ± 3.29) between the ketamine and midazolam groups (P = 0.09). Severe hemodynamic changes (hypoxia, significant bradycardia or tachycardia, and significant bradypnea or tachypnea) were not observed in any of the patients studied. Changes in heart rate (109.50 ± 8.96 beats/min), respiratory rate (25.1 ± 0.90 breaths/min), and SpO₂ (94.8 ± 0.8) showed no significant difference between the two groups (P = 0.74, P = 0.96, and P = 0.10, respectively), indicating that both interventions induced similar levels of sedation (P > 0.05). Conclusion: Both intranasal ketamine and oral midazolam are safe and effective pre-anesthetic agents with similar and optimal efficacy for preparing children and performing eye examinations under anesthesia. However, considering side effects and route tolerance, midazolam can be recommended. © 2025, Isfahan University of Medical Sciences(IUMS). All rights reserved.