Evaluation of optimal dosage combinations of oral midazolam and esketamine for pediatric preoperative sedation: A randomized, double-blind clinical trial.

Abstract

<h4>Objective</h4>To evaluate the efficacy and safety of combinations of oral midazolam and esketamine for pediatric preoperative sedation.<h4>Intervention</h4>Children aged 1‒6-years undergoing elective surgery were assigned to Group A (0.62 mg/kg midazolam and 2.05 mg/kg esketamine), Group B (0.41 mg/kg midazolam and 4.1 mg/kg esketamine), and Group C (0.21 mg/kg midazolam and 6.16 mg/kg esketamine). The combination was administered orally before anesthesia induction.<h4>Outcomes</h4>Primary outcome was sedation success, defined as a modified Ramsay sedation score ≥3a, low parent-child separation anxiety, and acceptance of the face mask for inhalation induction. Secondary outcomes included parental satisfaction, occurrence of Adverse Events (AE), and recovery times.<h4>Results</h4>The sedation success rate in Group B was 71.8%, which was significantly higher than Group A (53.5%, p < 0.05) but not Group C (68.2%, p > 0.05). There was no difference in the sedation success rate between Group A and Group C (p > 0.05). The overall incidence rate of AE in Group C was 25.90%, which was significantly higher than that in Group A (2.30%) and Group B (4.70%) (p < 0.05). No significant differences in sedation success rates were observed between genders within each group (p > 0.05).<h4>Conclusion</h4>The combination of 0.41 mg/kg midazolam and 4.1 mg/kg esketamine provided the most effective sedation with the fewest adverse events in pediatric patients. This regimen may reduce rescue sedation needs and improve perioperative flow.<h4>Trial registration</h4>http://www.chictr.org.cn (ChiCTR2400080633; date of first registration: February 4th, 2024).

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