comparison three different anti-convulsion drugs in children with uncontrolled convulsio
- Conditions
- 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.
- Registration Number
- CTRI/2016/05/006908
- Lead Sponsor
- The Director
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
1.Non¬-convulsive status epilepticus (NCSE).
2.Active or recent hemorrhage ( <1 week) from any site.
3.Documented platelet count <50,000, or INR >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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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