ABSTRACT
Objective: To compare the efficacy of phenytoin, valproate, andlevetiracetam in the management of pediatric convulsive statusepilepticus.Design: Randomized double-blind controlled clinical trial.Setting: Pediatric critical care division in a tertiary care institutefrom June, 2016 to December, 2018.Participants: 110 children aged three month to 12 year withconvulsive status epilepticus.Intervention: Patients not responding to 0.1 mg/kg intravenouslorazepam were randomly assigned (1:1:1) to receive 20 mg/kgof phenytoin (n=35) or valproate (n=35) or levetiracetam (n=32)over 20 minutes. Patients with nonconvulsive status epilepticus,recent hemorrhage, platelet count less than 50,000 orInternational normalized ratio (INR) more than 2, head injury orneurosurgery in the past one-month, liver or kidney disease,suspected or known neurometabolic or mitochondrial disorders orstructural malformations, and allergy to study drugs; and thosewho were already on any one of the study drugs for more than onemonth or had received one of the study drugs for current episode,were excluded.Outcome measure: The primary outcome was the proportionof patients that achieved control of convulsive status epilepticusat the end of 15 minutes after completion of the study druginfusion. Secondary outcomes were time to control of seizure,rate of adverse events, and the requirement of additional drugsto control seizure, length of ventilation, hospital stay, andfunctional status after three months (Glasgow Outcome Scale).Results: The study was stopped after the planned mid-interimanalysis for futility. Intention to treat analysis was done. There wasno difference in primary outcome in phenytoin (31/35, 89%),valproate (29/35, 83%), and levetiracetam (30/32, 94%) (P=0.38)groups. There were no differences between the groups forsecondary outcomes. One patient in the phenytoin group had afluid-responsive shock, and one patient in the valproate groupdied due to encephalopathy and refractory shock.Conclusions: Phenytoin, valproate, and levetiracetam wereequally effective in controlling pediatric convulsive statusepilepticus