Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Nov 13;24(1):724.
doi: 10.1186/s13063-023-07767-2.

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

Meng-Qiu Zhang  1 , Ming-Zhe Xu  1 , Yi He  1 , Yong-Wei Su  1 , Jun Ma  1 , Yun-Xia Zuo  2
Affiliations

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

Meng-Qiu Zhang et al. Trials. .

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.

Keywords: Midazolam; Preschool children; Randomized controlled trial; S-ketamine.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The schedule of major events that follows the Standard Protocol Items: Recommendation for Intervention Trials (SPIRIT) figure of enrolment, intervention, and assessment
Fig. 2
Fig. 2
The CONSORT 2010 flow diagram
See this image and copyright information in PMC

References

    1. Liang Y, Huang W, Hu X, Jiang M, Liu T, Yue H, Li XJTP. Preoperative anxiety in children aged 2–7 years old: a cross-sectional analysis of the associated risk factors. Transl Pediatr. 2021;10(8):2024–2034. doi: 10.21037/tp-21-215. - DOI - PMC - PubMed
    1. Dreger VA, Tremback TF. Management of preoperative anxiety in children. AORN J. 2006;84(5):778–780. doi: 10.1016/S0001-2092(06)63965-3. - DOI - PubMed
    1. Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006;118(2):651–658. doi: 10.1542/peds.2005-2920. - DOI - PubMed
    1. Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999;89(6):1346–1351. doi: 10.1213/00000539-199912000-00003. - DOI - PubMed
    1. Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999;88(5):1042–1047. - PubMed

Publication types

LinkOut - more resources