Comparison of levetiracetam as second-line drug with fosphenytoin in convulsive status epilepticus among children: A single center, open-label randomized controlled trial
S Anupama1, V Poovazhagi2, R Nisha2, S Suresh Kumar3, J Sathya3
1 Department of Pediatrics, Government Medical College and Hospital, Tiruvallur, Tamil Nadu, India
2 Department of Pediatric Intensive Care, Institute of Child Health and Hospital for Children, Egmore, Chennai, Tamil Nadu, India
3 Department of Pediatrics, Chengalpattu Medical College and Hospital, Chengalpattu, Chennai, Tamil Nadu, India
Dr. S Anupama
Flat No. 5, Kanakadhara, 20, Temple Avenue, Srinagar Colony, Saidapet, Chennai - 600 015, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Background: Status epilepticus (SE) is the most common neurologic emergency in the pediatric age group often serious and life-threatening. Although newer drugs were used, morbidity and mortality are still high. This study was done to compare the efficacy of levetiracetam with the existing second-line drug fosphenytoin in the treatment of SE.
Subjects and Methods: This was a prospective, randomized parallel group trial from Pediatric Intensive Care Unit of a Tertiary Care Institute. One hundred children were recruited according to the inclusion and exclusion criteria, 50 in fosphenytoin group and 50 in levetiracetam group. Two groups were compared with respect to clinical cessation of seizures, recurrence, adverse event, and outcome.
Results: Male-to-female ratio was 1.45:1. Seizure were controlled in 37 (74%) in fosphenytoin group and 28 (56%) in levetiracetam group) (P = 0.059). The mean time for cessation of seizures was 11.16 ± 3.58 min in fosphenytoin group as compared to was 12.78 ± 3.07 min in levetiracetam group (P = 0.059) The seizure recurrence in first 24 h (18 [36%] vs. 12 [24%]) (P = 0.643) and development of shock (14 [28%] vs. 11 [22%]) (P = 0.488) was comparable in two groups. Overall mortality was 10 (20%) in fosphenytoin group as compared to 7 (14%) levetiracetam group (P = 0.281).
Conclusions: Efficacy of intravenous levetiracetam is comparable to fosphenytoin as a second-line medication in the management of convulsive SE in children.