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
Clinical Trial
. 2025 Jun 1:19:4605-4615.
doi: 10.2147/DDDT.S515924. eCollection 2025.

The Influence of Age on the Effective Dosage of Intravenous Remimazolam for the Relief of Preoperative Anxiety in Pediatric Patients at Median and 95% Effective Doses: A Prospective Study

Yueyue Chen  1 , Wenhua Zhang  2 , Junyi Ma  1 , Wenxing Liu  1 , Xingrong Song  1 , Xi Chen  1
Affiliations
Clinical Trial

The Influence of Age on the Effective Dosage of Intravenous Remimazolam for the Relief of Preoperative Anxiety in Pediatric Patients at Median and 95% Effective Doses: A Prospective Study

Yueyue Chen et al. Drug Des Devel Ther. .

Abstract

Purpose: Preoperative anxiety is an urgent problem in pediatric patients. This trial evaluated intravenous remimazolam for preoperative sedation in pediatric patients, assessing efficacy, safety, and age-dependent dose effects.

Patients and methods: In this two-part study, Aged 1~6 years old, 293 ASA I-II children [Parental Separation Anxiety Score (PSAS) ≥3 after nonpharmacological interventions] were enrolled. Part I: children were divided into 5 groups according to their age, and the trial was conducted by the Dixon-Massey sequential method. The first child in each group received a dose of 0.3 mg/kg of remimazolam, with a drug dose gradient of 0.05 mg/kg. Part II: 150 children were randomly selected and assigned to receive remimazolam 0.2-0.3 mg/kg. The main observations of this study were sedation effect and safety.

Results: The ED50 and 95% confidence interval (CI) for children aged 1-2 years was 0.14 (0.11-0.16) mg/kg, for children aged 2-3 years was 0.14 (0.11-0.17) mg/kg, for children aged 3-4 years was 0.16 (0.12-0.19) mg/kg, and for children aged 4-5 years was 0.14 (0.11-0.16) mg/kg, 5-6 years 0.13 (0.10-0.16) mg/kg, with no significant difference between age groups (P=0.525). The ED95 for preoperative sedation in children aged 1-6 years was 0.29 mg/kg (95% CI: 0.27-0.40). The difference in MOAA/S scores between the different dose groups in Part II was statistically significant (p<0.001) at 2 minutes after dosing. None of the adverse events that occurred after the use of remimazolam in this trial required the use of medication for intervention.

Conclusion: Remimazolam can be effectively used for preoperative sedation in children aged 1-6 years with low circulatory and respiratory effects, and there was no difference in the effective dose of the drug by age.

Keywords: dose-effect relationship; drug; pediatric patient; sedation with wakefulness.

PubMed Disclaimer

Conflict of interest statement

The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Flow diagram of Part I.
Figure 2
Figure 2
Flow diagram of Part II.
Figure 3
Figure 3
Dixon-Massey up-and-down sequential allocation study of remimazolam for preoperative sedation in pediatric patients of different ages.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. West N, Christopher N, Stratton K, Görges M, Brown Z. Reducing preoperative anxiety with Child Life preparation prior to intravenous induction of anesthesia: a randomized controlled trial. Paediatr Anaesth. 2020;30(2):168–180. doi:10.1111/pan.13802 - DOI - PubMed
    1. Nair T, Choo CSC, Abdullah NS, et al. Home-Initiated-Programme-to-Prepare-for-Operation: evaluating the effect of an animation video on peri-operative anxiety in children: a randomised controlled trial. Eur J Anaesthesiol. 2021;38(8):880–887. doi:10.1097/EJA.0000000000001385 - DOI - PubMed
    1. Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015;2015(7):CD006447. doi:10.1002/14651858.CD006447.pub3 - DOI - PMC - PubMed
    1. Coté CJ. Sedation for the pediatric patient. A review. Pediatr Clin North Am. 1994;41(1):31–58. - PubMed
    1. Zhang MQ, Xu MZ, He Y, Su YW, Ma J, Zuo YX. Comparison of S-ketamine and midazolam for intravenous preoperative sedative and anxiolytic effects in preschool children: study protocol for a randomized controlled clinical trial. Trials. 2023;24(1):724. doi:10.1186/s13063-023-07767-2 - DOI - PMC - PubMed

Publication types