Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Banaras Hindu University
• Collaborator: Institute of Medical Sciences of the Banaras Hindu University (BHU),India
• Treatments: Etiracetam; Levetiracetam; Piracetam; Valproic Acid

Criteria

Inclusion Criteria:

1. Age - 1 year to 16 years

2. Gender - male and female both

3. Refractory generalized convulsive status epilepticus i.e. not responding to any two of the first line drugs

Exclusion Criteria:

1. Patients with epilepsia partialis continua.

2. Patients with definite history of any allergic reaction to intravenous levetiracetam or intravenous valproate, or any contraindications in giving these drugs.