Clinical Efcacy and Safety of Injectable Levetiracetam Versus Phenytoin as Second-Line Terapy in the Management of Generalized Convulsive Status Epilepticus in Children: An Open-Label Randomized Controlled Trial
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Background and Purpose Tere is sparsity of quality evidence for the use of drugs afer frst-line benzodiazepines in convulsive status epilepticus in children. Te aim of the study was to compare the clinical efcacy and safety of intravenous levetiracetam versus intravenous phenytoin as second-line drugs in the management of generalized convulsive status epilepticus in children. Methods Tis open-label randomized controlled trial was conducted in the Emergency Department of Te Children’s Hospital and Te Institute of Child Health, Multan, Pakistan over a period of 4 years and 6 months from January 2014 to June 2018. Tis study included 600 children with generalized convulsive status epilepticus: 300 in the 40 mg/kg levetiracetam group, and 300 in the 20 mg/kg phenytoin group. Cessation of a clinical seizure (seizure cessation rate) within 30 minutes afer the end of drug administration was the primary outcome in this study, and the presence or absence of adverse efects was noted as the secondary outcome. Data were analyzed using SPSS (version 20.0). Results Te children in the levetiracetam and phenytoin were aged 3.5±0.2 and 3.4±0.2 years (mean±SD), respectively, their seizure durations before the start of treatment were 25.1±0.6 and 23.8±0.4 minutes, and their treatment efficacies were 278/300 (92.7%) and 259/300 (83.3%). Levetiracetam was signifcantly more efective than phenytoin (p=0.012), with no signifcant diference in safety. Adverse events were observed in eight children in the phenytoin group. Conclusions Levetiracetam is signifcantly more efective than phenytoin for the treatment of convulsive status epilepticus in children who have failed to respond to benzodiazepines.
Abstract
Background and Purpose Tere is sparsity of quality evidence for the use of drugs afer frst-line benzodiazepines in convulsive status epilepticus in children. Te aim of the study was to compare the clinical efcacy and safety of intravenous levetiracetam versus intravenous phenytoin as second-line drugs in the management of generalized convulsive status epilepticus in children. Methods Tis open-label randomized controlled trial was conducted in the Emergency Department of Te Children’s Hospital and Te Institute of Child Health, Multan, Pakistan over a period of 4 years and 6 months from January 2014 to June 2018. Tis study included 600 children with generalized convulsive status epilepticus: 300 in the 40 mg/kg levetiracetam group, and 300 in the 20 mg/kg phenytoin group. Cessation of a clinical seizure (seizure cessation rate) within 30 minutes afer the end of drug administration was the primary outcome in this study, and the presence or absence of adverse efects was noted as the secondary outcome. Data were analyzed using SPSS (version 20.0). Results Te children in the levetiracetam and phenytoin were aged 3.5±0.2 and 3.4±0.2 years (mean±SD), respectively, their seizure durations before the start of treatment were 25.1±0.6 and 23.8±0.4 minutes, and their treatment efficacies were 278/300 (92.7%) and 259/300 (83.3%). Levetiracetam was signifcantly more efective than phenytoin (p=0.012), with no signifcant diference in safety. Adverse events were observed in eight children in the phenytoin group. Conclusions Levetiracetam is signifcantly more efective than phenytoin for the treatment of convulsive status epilepticus in children who have failed to respond to benzodiazepines.
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