[SP1-2E-3] Comparision of Levetiracetam and Valproate in children with Refractory Status Epilepticus in a resource constraint setting: A Randomized Trial
Background: Induced coma requires invasive and intensive monitoring which are frequently lacking in resource constraint settings. To our knowledge, there are no randomized trials or comparative studies to scientifically recommend their use in children with refractory status epilepticus.
Objective: The objective of this study was to compare the efficacy and safety of intravenous levetiracetam with intravenous valproate for the treatment of refractory status epilepticus in a resource constraint setting.
Setting: A hospital based, single center study
Design: Randomized, two arm, open-label, parallel group trial.
Participants/patients: Children aged 2-12 years, with ongoing seizures despite use of benzodiazepines AND intravenous phenytoin.
Intervention: Intravenous valproate 30 mg/kg in one arm and intravenous Levetiracetam 30 mg/kg in the other arm.
Main Outcome Measure(s): The primary outcome was proportion of children with cessation of all clinical seizures within 15 min of drug administration AND no recurrence of clinical seizure acitivity in the next 6 hours. Secondary outcomes were time to seizure cessation and tolerability of drugs.
Results: The trial was terminated after 14 months, with 36 (18 in each arm) recruitments. The primary endpoint was reached in 14(78%, 95% CI 55-91) in levetiracetam versus 13 (72%, 95% CI 49-87) in valproate arm. Time to seizure control was similar in the two arms. Seven in the levetiracetam arm and 11 in the valproate arm were ventilated and nine children died (5 in levetiracetam arm and 4 in the valproate arm).
Conclusions: This trial provides preliminary data that suggests that both levetiracetam and valproate have comparable efficacy in control of RSE and may be good options in a resource constraint setting.
Objective: The objective of this study was to compare the efficacy and safety of intravenous levetiracetam with intravenous valproate for the treatment of refractory status epilepticus in a resource constraint setting.
Setting: A hospital based, single center study
Design: Randomized, two arm, open-label, parallel group trial.
Participants/patients: Children aged 2-12 years, with ongoing seizures despite use of benzodiazepines AND intravenous phenytoin.
Intervention: Intravenous valproate 30 mg/kg in one arm and intravenous Levetiracetam 30 mg/kg in the other arm.
Main Outcome Measure(s): The primary outcome was proportion of children with cessation of all clinical seizures within 15 min of drug administration AND no recurrence of clinical seizure acitivity in the next 6 hours. Secondary outcomes were time to seizure cessation and tolerability of drugs.
Results: The trial was terminated after 14 months, with 36 (18 in each arm) recruitments. The primary endpoint was reached in 14(78%, 95% CI 55-91) in levetiracetam versus 13 (72%, 95% CI 49-87) in valproate arm. Time to seizure control was similar in the two arms. Seven in the levetiracetam arm and 11 in the valproate arm were ventilated and nine children died (5 in levetiracetam arm and 4 in the valproate arm).
Conclusions: This trial provides preliminary data that suggests that both levetiracetam and valproate have comparable efficacy in control of RSE and may be good options in a resource constraint setting.