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Lorazepam vs diazepam for pediatric status epilepticus: a randomized clinical trial.

Author(s): Chamberlain JM(1), Okada P(2), Holsti M(3), Mahajan P(4), Brown KM(1), Vance C(5), Gonzalez V(6), Lichenstein R(7), Stanley R(8), Brousseau DC(9), Grubenhoff J(10), Zemek R(11), Johnson DW(12), Clemons TE(13), Baren J(14); Pediatric Emergency Care Applied Research Network (PECARN).

Collaborators: King D, Kim C, Martz K, Zhao J, Walson P, Weise K, Das A, Venzon D, Wiedermann B, Koren G, Vocke C, Thompson A, Harris N, Riddle M, Brown L, Swerdlow P, Zajicek A, Nigrovic L, Lillis K, Mahajan P, Sonnett M, Shaw K, Powell E, Brown K, Ruddy R, Hoyle J, Borgialli D, Atherly-John Y, Gorelick M, Andrada E, Stanley R, Conners G, Pruitt C, Jaffe D, Lichenstein R, Dayan P, Alpern E, Bajaj L, Brown K, Borgialli D, Chamberlain J, Dean J, Gorelick M, Jaffe D, Kuppermann N, Kwok M, Lichenstein R, Lillis K, Mahajan P, Monroe D, Nigrovic L, Powell E, Rogers A, Ruddy R, Stanley R, Tunik M, Kavanaugh D, Park H, Dean J, Gramse H, Holubkov R, Donaldson A, Olson C, Zuspan S, Enriquez R, Brown K, Goldfarb S, Crain E, Kim E, Krug S, Monroe D, Nelson D, Berlyant M, Zuspan S, Gorelick M, Alpern L, Anders J, Borgialli D, Cimpello L, Donaldson A, Foltin G, Moler F, Shreve K, Nigrovic L, Chamberlain J, Dayan P, Dean JM, Holubkov R, Jaffe D, Powell E, Shaw K, Stanley R, Tunik M, Lillis K, Alessandrini E, Blumberg S, Enriquez R, Lichenstein R, Mahajan P, McDuffie R, Ruddy R, Thomas B, Wade J, Schalick W, Hoyle J, Atabaki S, Call K, Gramse H, Kwok M, Rogers A, Schnadower D, Kuppermann N.

Affiliation(s): Author information: (1)Division of Emergency Medicine, Children's National Medical Center, Washington, DC2The Pediatric Emergency Care Applied Research Network (PECARN). (2)University of Texas, Southwestern, Dallas. (3)The Pediatric Emergency Care Applied Research Network (PECARN)4Department of Pediatrics, University of Utah, Salt Lake City. (4)The Pediatric Emergency Care Applied Research Network (PECARN)5Department of Pediatrics, Children's Hospital of Michigan, Detroit. (5)The Pediatric Emergency Care Applied Research Network (PECARN)6University of California, Davis, Sacramento. (6)The Pediatric Emergency Care Applied Research Network (PECARN)7Baylor College of Medicine, Houston, Texas. (7)Department of Pediatrics, University of Maryland, Baltimore. (8)The Pediatric Emergency Care Applied Research Network (PECARN)9University of Michigan, Ann Arbor. (9)The Pediatric Emergency Care Applied Research Network (PECARN)10Department of Pediatrics, Medical College of Wisconsin, Milwaukee. (10)The Pediatric Emergency Care Applied Research Network (PECARN)11Children's Hospital of Colorado, Denver. (11)Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada. (12)Alberta Children's Hospital, Calgary, Alberta, Canada. (13)The EMMES Corp, Rockville, Maryland. (14)The Pediatric Emergency Care Applied Research Network (PECARN)15Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.

Publication date & source: 2014, JAMA. , 311(16):1652-60

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.

Page last updated: 2014-11-30

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