Comparative Evaluation of Intranasal Ketamine and Midazolam for Premedication in Children Undergoing Elective Surgery: A Prospective Study.

BACKGROUND: Preoperative anxiety can adversely affect anesthetic induction and perioperative outcomes in children. Intranasal ketamine and midazolam are commonly used noninvasive premedication agents, but evidence comparing their efficacy remains inconsistent. This study compared intranasal ketamine and midazolam in children undergoing elective surgery. METHODS: This prospective comparative study was conducted in the Department of Anesthesiology, Shri Guru Ram Rai Institute of Medical and Health Sciences, Dehradun, India, between August 2023 and July 2025. Seventy-two American Society of Anesthesiologists physical status I children aged three to eight years scheduled for elective surgery under general anesthesia were included. Seventy-two children were assigned alternately, with 36 receiving intranasal ketamine (5 mg/kg) and 36 receiving intranasal midazolam (0.2 mg/kg). Sedation, onset of sedation, child-parent separation, preoperative anxiety, mask acceptance during induction, perioperative hemodynamic parameters, and adverse events were assessed using standardized clinical scales. RESULTS: Baseline demographic characteristics were comparable between the two groups. The ketamine group demonstrated a significantly shorter onset of sedation than the midazolam group (4.06 ± 0.86 vs. 7.47 ± 1.61 minutes, p < 0.001). Following premedication, Ramsay Sedation Scale scores were significantly higher in the ketamine group, with deep sedation at 20 minutes observed in 19 (52.8%) children compared with nine (25.0%) in the midazolam group (p < 0.001). Child-parent separation was significantly better with ketamine, with excellent separation observed in 30 (83.3%) children compared with two (5.6%) in the midazolam group (p < 0.001). Children receiving ketamine also demonstrated lower preoperative anxiety, with 22 (61.1%) remaining calm and cooperative compared with eight (22.2%) in the midazolam group (p < 0.001), and better mask acceptance during anesthetic induction, with excellent or good acceptance observed in 32 (88.9%) vs. 17 (47.2%) children, respectively (p < 0.001). Heart rate, respiratory rate, systolic blood pressure, and oxygen saturation remained comparable between the groups at most perioperative time points. Ketamine was associated with a lower intraoperative heart rate and higher oxygen saturation after premedication. Mild intraoperative excessive secretions occurred in four (11.1%) children receiving ketamine compared with 0 (0.0%) in the midazolam group, although the difference was not statistically significant (p = 0.115). Postoperative secretions were more frequent with ketamine, occurring in six (16.7%) children compared with 0 (0.0%) in the midazolam group (p = 0.025), whereas postoperative restlessness occurred in seven (19.4%) vs. eight (22.2%) children (p = 0.772). No child in either group experienced postoperative nausea or vomiting, with 0 (0.0%) cases in both groups. CONCLUSIONS: In this prospective comparative study, intranasal ketamine was associated with faster onset and deeper sedation, better child-parent separation, and better mask acceptance than midazolam, with generally stable cardiorespiratory parameters. Postoperative secretions were more frequent with ketamine. Given the alternate allocation, potential unblinding, fixed assessment time, and small single-center sample, these findings are hypothesis-generating and require confirmation in larger randomized multicenter studies.