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ConSEPT trial: Levetiracetam is not superior to phenytoin in the management of convulsive status epilepticus
Design: The 'Convulsive Status Epilepticus Paediatric Trial' (ConSEPT) was an open label randomised controlled trial.
Allocation: 1:1 computer-generated block randomisation, stratified by site and age.
Setting: 13 emergency departments (ED) in New Zealand and Australia (8 tertiary paediatric EDs).
Patients: 234 children aged 3 months to 16 years presenting with convulsive status epilepticus. Patients had already received two doses of benzodiazepines.
Intervention: Levetiracetam 40 mg/kg over 5 min intravenous or intraosseous.
Comparison: Phenytoin 20 mg/kg over 20 min intravenous/intraosseous.
The participant was assessed 5 min after the infusion had finished; if seizure activity was present, the other study medication was also given. A video was used to independently assess the time of seizure cessation.
Primary outcomes: Clinical cessation of seizure activity 5 min after infusion completion.
Secondary outcomes: Clinical cessation of seizures 2 hours after infusion of 1 or 2 drugs, need for rapid sequence induction, time to seizure cessation, intensive care unit admission, serious adverse events, seizure status …
Contributors RAD wrote the abstract and commentary.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; internally peer reviewed.
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