title: Lorazepam vs diazepam for pediatric status epilepticus: a randomized clinical trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00621478.
authors.affiliation: Division of Emergency Medicine, Children's National Medical Center, Washington, DC2The Pediatric Emergency Care Applied Research Network (PECARN).
authors.forename: James M
authors.initials: JM
authors.lastname: Chamberlain
authors.affiliation: University of Texas, Southwestern, Dallas.
authors.forename: Pamela
authors.initials: P
authors.lastname: Okada
authors.affiliation: The Pediatric Emergency Care Applied Research Network (PECARN)4Department of Pediatrics, University of Utah, Salt Lake City.
authors.forename: Maija
authors.initials: M
authors.lastname: Holsti
authors.affiliation: The Pediatric Emergency Care Applied Research Network (PECARN)5Department of Pediatrics, Children's Hospital of Michigan, Detroit.
authors.forename: Prashant
authors.initials: P
authors.lastname: Mahajan
authors.affiliation: Division of Emergency Medicine, Children's National Medical Center, Washington, DC2The Pediatric Emergency Care Applied Research Network (PECARN).
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Brown
authors.affiliation: The Pediatric Emergency Care Applied Research Network (PECARN)6University of California, Davis, Sacramento.
authors.forename: Cheryl
authors.initials: C
authors.lastname: Vance
authors.affiliation: The Pediatric Emergency Care Applied Research Network (PECARN)7Baylor College of Medicine, Houston, Texas.
authors.forename: Victor
authors.initials: V
authors.lastname: Gonzalez
authors.affiliation: Department of Pediatrics, University of Maryland, Baltimore.
authors.forename: Richard
authors.initials: R
authors.lastname: Lichenstein
authors.affiliation: The Pediatric Emergency Care Applied Research Network (PECARN)9University of Michigan, Ann Arbor.
authors.forename: Rachel
authors.initials: R
authors.lastname: Stanley
authors.affiliation: The Pediatric Emergency Care Applied Research Network (PECARN)10Department of Pediatrics, Medical College of Wisconsin, Milwaukee.
authors.forename: David C
authors.initials: DC
authors.lastname: Brousseau
authors.affiliation: The Pediatric Emergency Care Applied Research Network (PECARN)11Children's Hospital of Colorado, Denver.
authors.forename: Joseph
authors.initials: J
authors.lastname: Grubenhoff
authors.affiliation: Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
authors.forename: Roger
authors.initials: R
authors.lastname: Zemek
authors.affiliation: Alberta Children's Hospital, Calgary, Alberta, Canada.
authors.forename: David W
authors.initials: DW
authors.lastname: Johnson
authors.affiliation: The EMMES Corp, Rockville, Maryland.
authors.forename: Traci E
authors.initials: TE
authors.lastname: Clemons
authors.affiliation: The Pediatric Emergency Care Applied Research Network (PECARN)15Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
authors.forename: Jill
authors.initials: J
authors.lastname: Baren
mesh_terms: D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D002675:Child, Preschool; D003975:Diazepam / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008140:Lorazepam / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D012008:Recurrence; D013226:Status Epilepticus / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D008140:Lorazepam; D003975:Diazepam