Abstract | IMPORTANCE: OBJECTIVE: 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: 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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Authors | 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, Pediatric Emergency Care Applied Research Network (PECARN) |
Journal | JAMA
(JAMA)
2014 Apr 23-30
Vol. 311
Issue 16
Pg. 1652-60
ISSN: 1538-3598 [Electronic] United States |
PMID | 24756515
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Anticonvulsants
- Lorazepam
- Diazepam
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Topics |
- Anticonvulsants
(adverse effects, therapeutic use)
- Child, Preschool
- Diazepam
(adverse effects, therapeutic use)
- Double-Blind Method
- Female
- Humans
- Infant
- Lorazepam
(adverse effects, therapeutic use)
- Male
- Recurrence
- Status Epilepticus
(drug therapy)
- Treatment Outcome
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