Background: Fosphenytoin (fPHT) and continuous intravenous midazolam (cMDL) had commonly been used as second-line treatments for pediatric status epilepticus (SE) in Japan. However, there is no comparative study of these two treatments. Methods: We included consecutive children who 1) were admitted to Kobe Children's Hospital because of convulsion with fever and 2) were treated with either fPHT or cMDL as second-line treatment for convulsive SE lasting for longer than 30 min. We compared, between the fPHT and cMDL groups, the proportion of barbiturate coma therapy (BCT), incomplete recovery of consciousness, mechanical ventilation, and inotropic agents. Results: The proportion of BCT was not significantly different between the two groups (48.7% [20/41] in fPHT and 35.3% [29/82] in cMDL, p = 0.17). The prevalence of incomplete recovery of consciousness, mechanical ventilation, and inotropic agents was not different between the two groups. After excluding 49 patients treated with BCT, incomplete recovery of consciousness 6 h and 12 h after onset was more frequent in the cMDL group than in the fPHT group (71.7% vs. 33.3%, p < 0.01; 56.6% vs. 14.2%, p < 0.01; respectively). Mechanical ventilation was more frequent in the cMDL group than in the fPHT group (32.0% vs. 4.7%, p = 0.01). Conclusions: Our results suggest that 1) the efficacy of fPHT and cMDL is similar, although cMDL may prevent the need for BCT compared with fPHT, and 2) fPHT is relatively safe as a second-line treatment for pediatric SE in patients who do not require BCT.
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