Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
This study is a randomized, open label, parallel group,comparing the safety and efficacy of
valproate and levetiracetam in patients of age group 1 to 16 years with status epilepticus
not responded to phenytoin and benzodiazepines approaching to pediatric emergency , IMS, BHU.
The primary outcome measures will be Proportion of children in either group who have
Cessation of all clinical seizure within 30 min of drug administration and secondary outcome
will be time taken to control seizure (minutes) from the initiation of infusion. Proportion
of children in either group who required additional drugs to abort ongoing clinical seizures,
rates of adverse events (hypotension, bradycardia, respiratory depression, PICU stay, in
hospital mortality) in the two groups were measured. Refractory status epilepticus condition
is major pediatric neurological emergency with high mortality and morbidity. Till now, the
treatment guidelines for it are based primarily on retrospective studies with very few
randomized studies. There is lack of sufficient data to recommend one drug over another for
treatment of refractory status epilepticus.
Phase:
Phase 2
Details
Lead Sponsor:
Banaras Hindu University
Collaborator:
Institute of Medical Sciences of the Banaras Hindu University (BHU),India