Health Condition 1: null- children who have active seizure, critically ill
Conditions
Interventions
Intervention1: injection levetiracetam: the study drug injection levetiracetam (40mg/kg)will be given concurrently with injection phenytoin (20mg/kg) in benzodiazepine resistant status epilepticus
Con
Sponsors
post graduate medical college and research institute Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 3month to 12 years presenting with convulsive status epilepticus(CSE) or occurrence of status epilepticus at pediatric Emergency or PICU of advanced pediatric center of PGIMER Eligibility criteria: Minimum two doses of benzodiazepines as first line treatment is to be given.
Exclusion criteria
Exclusion criteria: 4.3.1. Absence, myoclonic, non-convulsive status epilepticus, or infantile spasms Known case of chronic renal disease Previous administration of loading any IV antiepileptic drug within last 12 hours of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of children with successful clinical termination of seizure activity within 30 min after initiation of drug infusion in either group (Phenytoin and Levitracetam versus Phenytoin and placebo )Timepoint: within 30 minutes of starting the drug infusions | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the proportion of children with recurrence of seizure within 8 hours of stopping infusion Correlation of serum drug levels of levetiracetam and phenytoin with seizure control To compare the proportion of children with adverse events due to either phenytoin and levetiracetam combination or phenytoin and placebo combination Timepoint: recurrance of seizure within 8 hrs of infusion | — |
Countries
India
Contacts
Public Contactkeshavamurthy ML
Post graduate institute of medical education and research, Chandigarh
Outcome results
None listed