Health Condition 1: null- Children aged 3 months to 12 years of adult parents who present with CSE (clonic, tonic, tonic clonic, and myoclonic, focal or generalized) to Pediatric Critical Care Units.
Conditions
Interventions
Intervention1: Valproate: children in this group will receive intravenously 20 mg/kg bolus over 20 min one time.
Intervention2: Levetiracetam: children in this group will receive intravenously 20 mg/k
Sponsors
The Director
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 3 months to 12 years of adult parents who present with CSE (clonic, tonic, tonic clonic, and myoclonic, focal or generalized) to Pediatric Critical Care Units.
Exclusion criteria
Exclusion criteria: 1. Non¬-convulsive status epilepticus (NCSE). 2. Active or recent hemorrhage ( 3. Documented platelet count 2 4. Head injury or neurosurgery in the past one month. 5. Acute or chronic liver or kidney disease. 6. Suspected or known structural malformation or neurometabolic or mitochondrial disorders 7. Known or suspected allergy or intolerance to phenytoin or valproate or levetiracetam 8. Patients of epilepsy already on Levetiracetam ( > 20 mg/kg/day) or Valproate ( > 20mg/kg/day) or Phenytoin ( > 5 mg/kg/day) for more than 1 month. 9. Patients received appropriate dose of documented Levetiracetam or Valproate or Phenytoin outside hospital setting for this episode of CSE.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of phenytoin, valproate and levetiracetam in children with Convulsive status epilepticus in terms of proportion of patients achieved control of CSE at end 15 minutes after completion of trial drug infusion in the study groups.Timepoint: End 15 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study the time taken to control seizure (minutes) from the initiation of infusion in the study groups.Timepoint: at end of 15 minutes;2. To study the proportion of children in each group who required additional drugs to abort ongoing clinical seizures.Timepoint: after 15 minutes of infusion;3. To study the rates of adverse events (hypotension, bradycardia, respiratory depression) in the study groups.Timepoint: at end of 15 minutes;4. To study the length of mechanical ventilation if ventilated, hospital stays including PICU stayTimepoint: at time of hospital discharge;5. To study the functional status at 3 months of followup by Glasgow Outcome Scale (GOS) and m-GOS in the study groups.Timepoint: 90 days;mortalityTimepoint: at time of hospital and 28,90 days | — |
Countries
India
Contacts
Public ContactDr Ramesh Kumar R
JIPMER
Outcome results
None listed