EcLiPSE
Emergency treatment with Levetiracetam or Phenytoin in convulsive Status Epilepticus in children
Paciente / Población Intervención / Exposición Comparación Desenlace
In 286 children with benzodiazepine-refractory convulsive status epilepticus, levetiracetam did not shorten time to seizure cessation versus phenytoin.
N
286
Diseño
Open-label, multicentre, randomised superiority trial at 30 UK emergency departments; children aged 6 months to <18 years in convulsive status epilepticus requiring second-line treatment, randomised 1:1 (stratified by centre, research without prior consent) to intravenous levetiracetam 40 mg/kg (max 2.5 g) over 5 min or intravenous phenytoin 20 mg/kg (max 2 g) over at least 20 min, on top of the APLS algorithm; enrolment July 17, 2015 to April 7, 2018; modified intention-to-treat primary analysis.
Desenlace
Time from randomisation to cessation of all visible convulsive activity, judged by the treating clinician; censored at rapid sequence induction (+12 h) or death (+48 h).
ResultadoConvulsive status epilepticus terminated in 106/152 (70%) with levetiracetam vs 86/134 (64%) with phenytoin. Median time from randomisation to cessation 35 min (IQR 20 to not assessable) vs 45 min (24 to not assessable); HR 1.20 (95% CI 0.91-1.60), log-rank p=0.20. No significant difference in further anticonvulsants (38% vs 37%), rapid sequence induction (29% vs 35%) or critical care admission (64% vs 54%, p=0.08). Five serious adverse events (three in two phenytoin recipients, one levetiracetam, one who received both); two treatment-related, both in one phenytoin patient; one death from cerebral oedema unrelated to treatment.
Lyttle MD, Rainford NEA, Gamble C, et al. Levetiracetam versus phenytoin for second-line treatment of paediatric convulsive status epilepticus (EcLiPSE): a multicentre, open-label, randomised trial. Lancet. 2019;393(10186):2125-2134. 10.1016/s0140-6736(19)30724-x