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Bian Y, Zhou S, Hou H, et al. The optimal dose of oral midazolam with or without intranasal S-ketamine for premedication in children: a randomised, double blinded, sequential dose-finding trial. Transl Pediatr. 2021;10(11):2941-2951doi: 10.21037/tp-21-247.
Bian, Y., Zhou, S., Hou, H., Xu, T., & Huang, Y. (2021). The optimal dose of oral midazolam with or without intranasal S-ketamine for premedication in children: a randomised, double blinded, sequential dose-finding trial. Translational pediatrics, 10(11), 2941-2951. https://doi.org/10.21037/tp-21-247
Bian, Yong, et al. "The optimal dose of oral midazolam with or without intranasal S-ketamine for premedication in children: a randomised, double blinded, sequential dose-finding trial." Translational pediatrics vol. 10,11 (2021): 2941-2951. doi: https://doi.org/10.21037/tp-21-247
Bian Y, Zhou S, Hou H, Xu T, Huang Y. The optimal dose of oral midazolam with or without intranasal S-ketamine for premedication in children: a randomised, double blinded, sequential dose-finding trial. Transl Pediatr. 2021 Nov;10(11):2941-2951. doi: 10.21037/tp-21-247. PMID: 34976760; PMCID: PMC8649604.
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Transl Pediatr. 2021 Nov;10(11):2941-2951. doi: 10.21037/tp-21-247.

The optimal dose of oral midazolam with or without intranasal S-ketamine for premedication in children: a randomised, double blinded, sequential dose-finding trial.

Translational pediatrics

Yong Bian, Siyi Zhou, Huiyan Hou, Tao Xu, Yue Huang

Affiliations

  1. Department of Anesthesiology, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
  2. Department of Anesthesiology, the International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.

PMID: 34976760 PMCID: PMC8649604 DOI: 10.21037/tp-21-247

Abstract

BACKGROUND: Oral administration of midazolam syrup is one of the most favorable methods of premedication, the optimal dose of midazolam and midazolam with S-ketamine for preschool children has not been determined. This prospective, double-blind, randomized, sequential dose-finding study was designed to estimate the 90% effective doses of oral midazolam with and without intranasal S-ketamine in a grade III child medical center.

METHODS: Eighty successive children were recruited and randomly allocated to midazolam group and midazolam with S-ketamine group. The initial oral doses of midazolam were 0.25 mg/kg in both groups, and the dose of midazolam for the next child was based on the response of the preceding child as the biased coin up-and-down designed. The primary outcome was parental separation anxiety score = 1 throughout the period of transferring from premedication center to the operation room 30 min after premedication. Secondary outcomes were the preoperative and post-operative observations. Finally, the 90% effective dose and 95% confidence intervals were estimated by isotonic regression.

RESULTS: The 90% effective dose of oral midazolam or oral midazolam with intranasal S-ketamine was 0.461 mg/kg (95% confidence interval: 0.425-0.488) and 0.253 mg/kg (95% confidence interval: 0.242-0.278), respectively. Oral midazolam with intranasal S-ketamine was quicker onset (8.9±3.8

CONCLUSIONS: A suggestion of oral midazolam 0.3 mg/kg with intranasal small dose of S-ketamine could be used as premedication for preschool children.

TRIAL REGISTRATION: Chinese Clinical Trial Registry.

2021 Translational Pediatrics. All rights reserved.

Keywords: 90% effective dose (ED90); S-ketamine; midazolam; premedication; preschool children

Conflict of interest statement

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://dx.doi.org/10.21037/tp-21-247). The authors have no conflicts of interest to declare.

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