Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus
Condition: Grand Mal Status Epilepticus
MeSH terms: Status Epilepticus
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Intravenous levetiracetam; Sodium valproate
Intervention type(s): Drug; Drug
Intervention description(s): intravenous levetiracetam(30mg/kg bolus followed by 20mg/kg/dose IV 12 hourly).; intravenous sodium valproate(20mg/kg bolus followed by 10 mg/kg/dose IV 8hrly)
Other intervention name(s): injection Levera; injection Encorate
Intervention MeSH terms: Levetiracetam; Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RSE