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Original Investigation |

Lorazepam vs Diazepam for Pediatric Status Epilepticus:  A Randomized Clinical Trial

James M. Chamberlain, MD1,2; Pamela Okada, MD3; Maija Holsti, MD2,4; Prashant Mahajan, MD, MBA2,5; Kathleen M. Brown, MD1,2; Cheryl Vance, MD2,6; Victor Gonzalez, MD2,7; Richard Lichenstein, MD8; Rachel Stanley, MD, MPH2,9; David C. Brousseau, MD, MPH2,10; Joseph Grubenhoff, MD2,11; Roger Zemek, MD12; David W. Johnson, MD13; Traci E. Clemons, PhD14; Jill Baren, MD, MPH2,15 ; for the Pediatric Emergency Care Applied Research Network (PECARN)
[+] Author Affiliations
1Division of Emergency Medicine, Children’s National Medical Center, Washington, DC
2The Pediatric Emergency Care Applied Research Network (PECARN)
3University of Texas, Southwestern, Dallas
4Department of Pediatrics, University of Utah, Salt Lake City
5Department of Pediatrics, Children’s Hospital of Michigan, Detroit
6University of California, Davis, Sacramento
7Baylor College of Medicine, Houston, Texas
8Department of Pediatrics, University of Maryland, Baltimore
9University of Michigan, Ann Arbor
10Department of Pediatrics, Medical College of Wisconsin, Milwaukee
11Children’s Hospital of Colorado, Denver
12Department of Pediatrics, Children’s Hospital of Eastern Ontario, Ottawa, Ontario, Canada
13Alberta Children’s Hospital, Calgary, Alberta, Canada
14The EMMES Corp, Rockville, Maryland
15Department of Pediatrics, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
JAMA. 2014;311(16):1652-1660. doi:10.1001/jama.2014.2625.
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Importance  Benzodiazepines 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.

Objective  To test the hypothesis that lorazepam has better efficacy and safety than diazepam for treating pediatric status epilepticus.

Design, Setting, and Participants  This 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.

Interventions  Patients 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 Measures  The 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.

Results  Cessation 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 Relevance  Among 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 Registration  clinicaltrials.gov Identifier: NCT00621478

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Figure.
CONSORT Diagram of Participants in the Pediatric Seizure Study
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