A pharmacokinetic bridge and an open-label effectiveness proxy supply different evidence.
Thirty-six children aged two to five entered the study and thirty-five contributed pharmacokinetic data. Exposure modeling was compared with older age groups. During follow-up, a second dose was used for thirty-seven of 227 seizure events, while most events did not receive a repeat dose.
Absence of repeat dosing is not a directly measured seizure-termination time. Open-label decisions reflect clinical judgment and instructions. The small sample limits uncommon-event safety estimates, and average exposure does not predict every child’s concentrations.
Keep the PK population and event denominator separate. The study cannot establish an individual dose history or guarantee a particular response. For forensic review, use the actual device administration, timing, seizure observations and subsequent care rather than turning the repeat-dose percentage into universal efficacy.
Source: PMC12455456, supplied full-text paper. Findings are paraphrased; forensic implications are an interpretation.
Related: Intranasal Remimazolam Dose-Finding Defined Success With a Pediatric Sedation Scale.