Emergency medicine physicians are well versed in treating status epilepticus refractory to first line treatment with benzodiazepines. There are several widely accepted second line treatments for status epilepticus. It is not clear, however, which second line options might be most effective for different age groups in order to limit irreversible neuronal injury and complications secondary to metabolic and respiratory derangements. The goal of this double-blind randomized clinical trial was to compare the efficacy and safety of levetiracetam, fosphenytoin, and valproate for status epilepticus refractory to benzodiazepines by age group. The study was run by the Neurological Emergencies Treatment Trials and the Pediatric Emergency Care Applied Research Network. Patients met inclusion criteria if they were at least two years old and if they needed treatment for status epilepticus, which was defined as generalized convulsive seizures lasting more than five minutes despite treatment with adequate benzodiazepines. An adequate cumulative dose of benzodiazepine was defined for patients thirty-two kilograms or heavier and was weight based for patients less than thirty-two kilograms. Patients were excluded if they were pregnant, from prison, postanoxic, allergic to or had contraindications to the study drugs, or had seizures secondary to trauma, hypoglycemia, or hyperglycemia. Patients who had been treated initially with medications other than benzodiazepines were also excluded. Patients included in the study were recruited from 58 hospital emergency departments in the US and were randomly assigned in a response-adaptive manner using Bayesian methods. Patients were then stratified into three age groups including children (<18 years, adults (18-65 years), and older adults (>65 years). The primary efficacy outcome of this trial was the cessation of clinically apparent seizures with improvement in mental status sixty minutes after the study drug was administered, without any additional antiseizure medications. The primary safety outcomes included life-threatening hypotension or cardiac arrhythmia. Secondary safety outcomes included requirement of intubation within sixty minutes of administering the study drug, acute respiratory depression any time during the study period, and mortality.
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