Randomized controlled trial of levetiracetam versus fosphenytoin for convulsive status epilepticus in children

Abstract

Introduction: Convulsive status epilepticus (CSE) is a common neurological emergency in childhood carrying a risk of significant morbidity and mortality. The current recommended first choice second line treatment in children is phenytoin / fosphenytoin although there is lack of evidence for its use and it is associated with significant side effects. Emerging evidence suggest that intravenous (IV) levetiracetam may be more effective with fewer side effects. The objective of this study was to compare the efficacy and safety of IV levetiracetam as a second line treatment for CSE with IV fosphenytoin in Indian children. Methods: Design: Prospective randomized controlled trial. Study setting: Paediatric emergency department of a Medical College in Tamilnadu, India from January 2017 to June 2017. Study population: 50 children aged 3 months to 12 years admitted for CSE and in whom seizure has failed to terminate with 2 doses of benzodiazepine. Intervention: 20mg Phenytoin equivalent (PE)/kg of fosphenytoin or 30mg/kg of levetiracetam administered intravenously over 7 minutes. Primary outcome: clinical cessation of seizures five minutes following the completion of the infusion of the study medication. Secondary outcome: seizure recurrence within 24 hours, drug related adverse events and length of PICU and hospital stay. Results: Fosphenytoin terminated seizures earlier than levitiracetam (p= 0.029). There was no significant difference between the two drugs in other parameters including seizure control rate (p=0.667), seizure recurrence (p=0.44), seizure free duration (p=0.8), PICU stay (p=0.105) and hospital stay (p=0.311). Conclusion: Levetiracetam may be an effective alternative to fosphenytoin in the management of convulsive status epilepticus in children.