• James M Chamberlain, Pamela Okada, Maija Holsti, Prashant Mahajan, Kathleen M Brown, Cheryl Vance, Victor Gonzalez, Richard Lichenstein, Rachel Stanley, David C Brousseau, Joseph Grubenhoff, Roger Zemek, David W Johnson, Traci E Clemons, Jill Baren, and Pediatric Emergency Care Applied Research Network (PECARN).
• Division of Emergency Medicine, Children's National Medical Center, Washington, DC2The Pediatric Emergency Care Applied Research Network (PECARN).
• JAMA. 2014 Apr 23; 311 (16): 1652-60.

ImportanceBenzodiazepines are considered first-line therapy for pediatric status epilepticus. Some studies suggest that lorazepam may be more effective or safer than diazepam, but lorazepam is not Food and Drug Administration approved for this indication.ObjectiveTo test the hypothesis that lorazepam has better efficacy and safety than diazepam for treating pediatric status epilepticus.Design, Setting, And ParticipantsThis double-blind, randomized clinical trial was conducted from March 1, 2008, to March 14, 2012. Patients aged 3 months to younger than 18 years with convulsive status epilepticus presenting to 1 of 11 US academic pediatric emergency departments were eligible. There were 273 patients; 140 randomized to diazepam and 133 to lorazepam.InterventionsPatients received either 0.2 mg/kg of diazepam or 0.1 mg/kg of lorazepam intravenously, with half this dose repeated at 5 minutes if necessary. If status epilepticus continued at 12 minutes, fosphenytoin was administered.Main Outcomes And MeasuresThe primary efficacy outcome was cessation of status epilepticus by 10 minutes without recurrence within 30 minutes. The primary safety outcome was the performance of assisted ventilation. Secondary outcomes included rates of seizure recurrence and sedation and times to cessation of status epilepticus and return to baseline mental status. Outcomes were measured 4 hours after study medication administration.ResultsCessation of status epilepticus for 10 minutes without recurrence within 30 minutes occurred in 101 of 140 (72.1%) in the diazepam group and 97 of 133 (72.9%) in the lorazepam group, with an absolute efficacy difference of 0.8% (95% CI, -11.4% to 9.8%). Twenty-six patients in each group required assisted ventilation (16.0% given diazepam and 17.6% given lorazepam; absolute risk difference, 1.6%; 95% CI, -9.9% to 6.8%). There were no statistically significant differences in secondary outcomes except that lorazepam patients were more likely to be sedated (66.9% vs 50%, respectively; absolute risk difference, 16.9%; 95% CI, 6.1% to 27.7%).Conclusions And RelevanceAmong pediatric patients with convulsive status epilepticus, treatment with lorazepam did not result in improved efficacy or safety compared with diazepam. These findings do not support the preferential use of lorazepam for this condition.Trial Registrationclinicaltrials.gov Identifier: NCT00621478.

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