ConSEPT
Convulsive Status Epilepticus Paediatric Trial
Patient / Population Intervention / Exposure Comparison Outcome
In 233 children with benzodiazepine-refractory convulsive status epilepticus, levetiracetam did not achieve seizure cessation more often than phenytoin.
N
233
Design
Open-label, multicentre, 1:1 randomised controlled superiority trial at 13 emergency departments in Australia and New Zealand; children aged 3 months to 16 years with convulsive status epilepticus refractory to first-line benzodiazepines, randomised (permuted blocks, stratified by site and age ≤5 vs >5 years) to phenytoin 20 mg/kg IV/IO over 20 min or levetiracetam 40 mg/kg IV/IO over 5 min; intention-to-treat analysis with blinded video adjudication of the primary outcome; enrolment March 19, 2015 to Nov 29, 2017; ACTRN12615000129583.
Endpoint
Clinical cessation of seizure activity 5 min after completion of the study-drug infusion.
ResultSeizures stopped in 68/114 (60%) with phenytoin versus 60/119 (50%) with levetiracetam (risk difference -9.2%, 95% CI -21.9 to 3.5; p=0.16) — levetiracetam was not superior. One child in the phenytoin group died at 27 days from haemorrhagic encephalitis, not attributed to the study drug; there were no other serious adverse events.
Dalziel SR, Borland ML, Furyk J, et al. Levetiracetam versus phenytoin for second-line treatment of convulsive status epilepticus in children (ConSEPT): an open-label, multicentre, randomised controlled trial. Lancet. 2019;393(10186):2135-2145. 10.1016/s0140-6736(19)30722-6