Remimazolam ED90 Dose for Pediatric Preoperative Anxiety: 80 Patient Study

Showcasing the 90% effective dose (ED90) of intravenous remimazolam for alleviating preoperative anxiety in 80 pediatric patients aged 1–6 years. The study, conducted from April to August 2025, stratified patients into younger (1 to <4 years) and older (4–6 years) groups, finding statistically significant different ED90 values between them.

Use Cases

• Estimate the ED90 dose of remimazolam for preoperative anxiolysis in the younger (1 to <4 years) age group using the reported 0.20 mg/kg value and its confidence interval.
• Compare the statistically significant difference in ED90 values between the younger and older (4–6 years) patient groups based on non-overlapping 83% confidence intervals.
• Apply the biased coin design (BCD) methodology described to model dose escalation/de-escalation sequences for pediatric sedation studies.
• Analyze the relationship between patient age group and the effective dose required, noting the lower weight-based dose for the older group.

Strengths

• Results are based on data from 80 pediatric patients, with 40 patients in each of the two defined age groups.
• The study provides precise ED90 point estimates (e.g., 0.20 mg/kg, 0.15 mg/kg) with calculated 90% and 83% confidence intervals for statistical rigor.
• Data collection followed a defined prospective clinical trial protocol (ChiCTR2500098747) from April to August 2025.

Limitations

• The dataset is very small (14.0 KB), likely containing only summary results (e.g., ED90 estimates, CIs) rather than raw patient-level data.
• The sample is limited to 80 patients from a single study, which may not be representative of broader pediatric populations.
• The primary file format is a DOC document, which is not a structured data format and may require manual extraction of numerical results.

Provenance

Source

Clinical study authored by Xu-ming Zhu, shared via figshare.

Collection Method

Prospective dose-finding study using a biased coin design (BCD) for dose adjustment, with isotonic regression and bootstrapping for ED90 estimation.

Time Range

Study enrollment from April to August 2025.

Freshness

Data reflects a study conducted in 2025 and was last updated on the platform in March 2026.