Efficacy and Safety of Different Doses of Midazolam Oral Solution for Cleft lip and Palate Repair in Children: A Randomized Controlled Study.

This study aimed to compare the efficacy and safety of midazolam oral solution in children undergoing cleft lip and palate repair surgery. Children aged 4 months to 14 years old were randomly assigned to 3 groups: group A, group B, and group C. Group A received 0.3 mg/kg midazolam oral solution, group B received 0.5 mg/kg midazolam oral solution, and group C received normal saline 30 min before entering the operating room. The Ramsay Sedation Score (RSS), Mask Acceptance Score (MAS), and Pediatric Anesthesia Emergence Delirium (PAED) scale at the post-anesthesia care unit (PACU) were recorded. The secondary outcomes were the postoperative side effects during the PACU stay and the perioperative hemodynamic fluctuation. Of 75 patients enrolled, 74 completed the study. Compared with group C, groups A and B demonstrated increased RSS, reduced MAS, and PAED scale scores ( P < 0.05). Compared with group A, group B exhibited lower PAED scores, longer awakening times, and PACU stays ( P < 0.05). No significant differences were observed among the 3 groups in perioperative hemodynamic fluctuation, FLACC scores, extubation times, or postoperative side effects ( P > 0.05). These findings supported that midazolam oral solution provides effective preoperative sedation in children undergoing cleft lip and palate repair, improves mask acceptance, and reduces the incidence of emergence agitation. While the 0.5 mg/kg dose provides better mask acceptance, adequate sedation, and less emergence agitation than 0.3 mg/kg dose, it also requires a slightly longer recovery time and duration of staying PACU.