Retrospective Analysis of Midazolam Hydrochloride Oral Solution for Preoperative Anxiety and Sedation in Pediatric Patients: Evaluation of Efficacy and Safety

Background Midazolam is widely used for preoperative anxiety and sedation in pediatric patients.This study aims to analyze the effectiveness of midazolam hydrochloride oral solution in alleviating preoperative anxiety and providing sedation in pediatric patients, while concurrently evaluating its safety profile. Methods In this retrospective study, 52 pediatric patients were enrolled. Anxiety and sedation levels were primarily assessed using an anxiolysis score and the Ramsay Sedation Score. The primary efficacy endpoints were the proportion of children achieving successful anxiolysis and successful sedation within 30 minutes post-administration. Secondary efficacy endpoints included the time from administration to successful anxiolysis and successful sedation, the parental separation score or a cooperation score, satisfaction ratings from both guardians and anesthesiologists regarding the medication, and the pediatric post-anesthesia care unit (PACU) recovery time. Furthermore, the incidence of adverse events, including those related to the gastrointestinal, respiratory, and nervous systems, was analyzed. Results Within 30 minutes, the successful anxiolysis rate was 100%, with a failure rate of 0%. The mean time to achieve successful anxiolysis was 7.72 ± 3.50 minutes. The Ramsay sedation success rate was 83.72%, with a failure rate of 16.28%. The mean time to achieve successful sedation was 16.08 ± 4.96 minutes.The cooperation score was 3.9 ± 0.21.Postoperative guardian satisfaction score averaged 4.30 ± 0.74, and anesthesiologist satisfaction score averaged 4.21 ± 0.91. The mean PACU recovery time was 101.16 ± 41.84 minutes.Regarding adverse events, the incidence of both nausea and vomiting was 13.96%, while the incidence of prolonged sedation was 32.56%. Conclusion Midazolam hydrochloride oral solution is effective in alleviating preoperative anxiety and providing satisfactory sedation in pediatric patients. Furthermore, it demonstrates high satisfaction rates among both guardians and anesthesiologists. The treatment was well-tolerated with no serious adverse events reported, thereby confirming its favorable efficacy and safety profile. Ethics The study population comprised pediatric patients who underwent elective surgery under general anesthesia at Sichuan Provincial People's Hospital between April and August 2025. The study received approved from the Institutional Ethics Committee (approval no. 2025836), and was registered at the Chinese Clinical Trial Registry (registration number: ChiCTR2500115877).