A clinical trial to study the effects of two drugs, levetiracetam and valproate in patients with refractory status epilepticus
- Conditions
- refractory status epilepticus
- Registration Number
- CTRI/2013/11/004178
- Lead Sponsor
- pgimer
- Brief Summary
This study is a randomized, open label, parallel group,comparing the safety and efficacy of valproate and levetiracetam in patients of age group 2 to 12 years with status epilepticus not responded to phenytoin 30 mg/kg and benzodiazepines approaching to pediatric emergency , pgimer The primary outcome measures will be 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 hours 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, ventilation, PICU stay, in hospital mortality) in the two groups were measured
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 80
•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.
- •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 <50,000, or INR>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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •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 hours 15 min
- Secondary Outcome Measures
Name Time Method •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
Trial Locations
- Locations (1)
Department of Pediatrics
🇮🇳Chandigarh, CHANDIGARH, India
Department of Pediatrics🇮🇳Chandigarh, CHANDIGARH, IndiaAlla Bharath kumarPrincipal investigator8872406999bharath54mbbs@gmail.com