Abstract
Aims & Objectives: Background and Aim Current guidelines recommend initial benzodiazepine followed by phenytoin to control status epilepticus (SE). However, with this regimen seizures may remain uncontrolled in 50–60% of cases. Prolongation of seizures makes it refractory. We therefore planned this study to see if combination therapy controls seizures early. Aims: To compare seizure control with phenytoin + levetiracetam versus phenytoin monotherapy. Methods Sixty children 3m-12years, presenting to pediatric emergency between January-December 2017 in SE not controlled with initial 2 doses of benzodiazepines were enrolled. They were randomized into Group A (phenytoin + levetiracetam) or Group B (phenytoin + placebo). Primary outcome was seizure termination within 30 minutes of therapy. Standard care was provided to all. Serum levels of phenytoin and/or levetiracetam were measured at 1 hour of infusion. Patients were monitored for drug related adverse events. Trial was registered in Clinical Trials Registry of India (CTRI/2017/17/011050). Nonparametric continuous data was analyzed with student t-test and categorical variables with Chi square test. Results Seizure control was achieved in 25/28 children (75%) in Group A and 23/32 children (72%) in Group B, p=0.77. One child (3.6%) had recurrence of seizure within 8 hour in Group A and 3 (9.4%) in Group B (RR 0.35 95% 0.035–3.65) p=0.616. Serum levels of levetiracetam and phenytoin levels were similar in both the groups. No significant drug adverse effects were noted Conclusions Trend towards better seizure control was seen in phenytoin + levetiracetam group as compared to phenytoin alone though results were not statistically significant due to small sample size.
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