Grand Mal Status Epilepticus Clinical Trial
Official title:
Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus : An Open Randomized Study
This study is a randomized, open label, parallel group,comparing the safety and efficacy of valproate and levetiracetam in patients of age group 1 to 16 years with status epilepticus not responded to phenytoin and benzodiazepines approaching to pediatric emergency , IMS, BHU. The primary outcome measures will be Proportion of children in either group who have Cessation of all clinical seizure within 30 min of drug administration 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, PICU stay, in hospital mortality) in the two groups were measured. Refractory status epilepticus condition is major pediatric neurological emergency with high mortality and morbidity. Till now, the treatment guidelines for it are based primarily on retrospective studies with very few randomized studies. There is lack of sufficient data to recommend one drug over another for treatment of refractory status epilepticus.
In our study patients were considered to have RSE if children were still having active
convulsions despite receiving injection lorazepam intravenously at a dose of 0.1 mg/kg (max
4 mg) at a rate maximum upto 2 mg/min or intravenous diazepam at a dose of 0.2 - 0.3 mg/Kg
(maximum 10 mg) slowly or intravenous midazolam at a dose of 0.15 - 0.2 mg/kg(max 5 mg). In
case of children with difficult intravenous access buccal/nasal midazolam 0.2 - 0.3 mg/kg
(maximum 5 mg) per rectal diazepam 0.5 mg/kg (maximum 10 mg) or intramuscular midazolam 0.2
mg/kg (maximum 5 mg). If seizure continued at 5 minutes, a repeat dose of benzodiazepine was
given with same dose. At 10 minutes, if the seizure activity still remains intravenous
phenytoin was given at a dose of 20mg/kg(maximum- 1000mg) at a rate of 1mg/kg/minute or
intravenous fosphenytoin at 20mg PE/kg (if available) at a rate of 3mg PE/kg/minute.
Patients having seizure activity despite administration of above medications were considered
to have RSE. Out of thousands of patients seen in outdoor and emergency ward, 80 patients
were diagnosed to have RSE and met the inclusion criteria. After counselling the
parents/guardians about the medications and obtaining a written informed consent they were
randomized to into two groups : sodium valproate(V) and levetiracetam group(L), using a
computer generated randomization chart. Forty patients in group V received intravenous
valproic acid in dose of 20 mg/kg as loading dose at a rate of 40 mg/min after dilution with
normal saline followed by maintenance dose of 10mg/kg/dose 8 hourly. In group L patients
received intravenous levetiracetam as loading dose of 30 mg/kg at a rate of 50 mg/min
followed by 20mg/kg/dose 12 hourly.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01586208 -
Refractory Status Epilepticus Treatment Study
|
Phase 3 |