Comparison of S-ketamine and midazolam for intravenous preoperative sedative and anxiolytic effects in preschool children: study protocol for a randomized controlled clinical trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 24; no. 1; p. 724
• Main Authors: Zhang, Meng-Qiu, Xu, Ming-Zhe, He, Yi, Su, Yong-Wei, Ma, Jun, Zuo, Yun-Xia
• Format: Journal Article
• Language: English
• Published: BioMed Central 13-11-2023; BMC
• Subjects: Analgesics; Anesthesia; Anxiety; Blood pressure; Caregivers; Clinical trials; Consent; Drugs; Elective surgery; Heart rate; Intervention; Ketamine; Midazolam; Oxygen saturation; Pediatrics; Pharmaceuticals; Preschool children; Randomized controlled trial; Recovery (Medical); S-ketamine; China
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-023-07767-2

Abstract
Background
Preoperative anxiety management is gaining particular attention in paediatric anaesthesia. Pharmacological and non-pharmacological resorts can be implemented to address this special issue. Despite the various approaches currently used for preoperative sedation in children, the different sedative and anti-anxiety effects between the newly marketed anaesthetic, S-ketamine, and the traditional sedative, midazolam, are still unclear.
Methods
This is a patient- and assessor-blinded randomized controlled clinical trial. Participants (
n
 = 110) will receive S-ketamine (0.5 mg/kg) or midazolam (0.08 mg/kg) intravenously administrated at a ratio of 1:1 in the anaesthesia holding area. The primary outcome of this study is the sedative effect evaluated via the change in the modified Yale preoperative anxiety scale. It will be performed at two timepoints: in the pre-anaesthetic holding area before premedication (baseline, marked as T0) and about 5 min after premedication in the operating room without the existence of their guardians (marked as T1). Our secondary objectives include the parent separation anxiety score, postoperative agitation, caregivers’ and anaesthesia care providers’ satisfaction, and mask compliance.
Discussion
This randomized controlled trial is the first study to compare the anti-anxiety effect of intravenous S-ketamine and midazolam. We will provide a new approach for the clinical management of preoperative anxiety in preschool children posted for elective surgery.
Trial registration
ChiCTR2300069998. Registered on 30 March 2023.