Health Condition 1: null- refractory status epilepticus
Conditions
Interventions
Intervention1: levetiracetam: intravenous 30mg/kg in 20 ml normal saline over 10 min
Control Intervention1: valproate: intravenous 30mg/kg in 20 ml normal saline over 10 min
Sponsors
pgimer
Eligibility
Inclusion criteria
Inclusion criteria: •Children aged 2 to 12 years old of either sex with ongoing clinical seizures(clonic, tonic, tonic clonic, myoclonic, focal or generalized) •Clinical seizures despite use of one or more doses of benzodiazepines (IV, IN, Buccal) and IV Phenytoin of 30 mg/kg or includes those who respond to initial doses (30 mg/kg ) of phenytoin but have recurrence within 6 hours of drug administration
Exclusion criteria
Exclusion criteria: •Non-convulsive status epilepticus . Known or suspected cases of neurometabolic or mitochondrial disorders •Acute or chronic liver or kidney disease •Head injury or neurosurgery in the past one month. •Active or recent hemorrhage from any site •Documented platelet count 2 •Known or suspected allergy or intolerance to either valproate or levetiracetam •Patients of epilepsy already on LEV( >20mg/kg/day) or VPA( >20mg/kg/day)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Proportion of children in either group who have Cessation of all clinical seizure within 15 min of drug administration and no recurrence for the next 6 hoursTimepoint: 15 min | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Time taken to control seizure (minutes) from the initiation of infusion â?¢Proportion of children in either group who required additional drugs to abort ongoing clinical seizures â?¢Rates of adverse events (hypotension, bradycardia, respiratory depression, ventilation, PICU stay, in hospital mortality) in the two groups Timepoint: time of seizure cessation | — |
Countries
India
Contacts
Public ContactDr Pratibha singhi
Advanced Pediatric Centre PGIMER
Outcome results
None listed