Interventions
SE, convulsions, seizures
Resuscitation and stabilisation were simultaneously performed. Diazepam was intravenously administered at 1–20 mg. The physician selected the dose of diazepam to stop seizures. Following the intravenous administration of diazepam, electronic data capturing (EDC) (TXP Medical) was registered using a smartphone or personal computer, after which data were rapidly randomised and allocated to the FPHT and LEV groups. Block randomisation was performed using EDC, in which a random sequence was automatically generated for the two, four and eight participant units in each hospital. Either of the two, four or eight blocks was also randomly assigned. Therefore, stratification was performed only for the facilities.In the FPHT group, FPHT at 22.5 mg/kg (phenytoin equivalent dose of 15 mg/kg) was intravenously administered in 100 mL of normal saline after diazepam at an administration rate not exceeding 3 mg/kg/min or 150 mg/min. In the LEV group, LEV at 1000–3000 mg was intravenously administered in 100 mL of normal saline after diazepam at an administration rate of 2–5 mg/kg/min. In both groups, height and body weight were estimated from body habitus, family information or patient records. All intervention medication doses were approved by the Japanese SE guidelines.If convulsions were not stopped by these treatments, midazolam, propofol, thiopental or thiamylal was administered as a third-line treatment according to the Japanese guidelines.