Comparison Between Efficacy of Levetiracetam Versus Valproic Acid in Pediatric Patients With Status Epilepticus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Sustained control of seizure activity
Study Overview
Brief Summary
Since there is a significant degree of variability in the results of previous studies and there exists a thirst for local data regarding this topic, the current study was planned, with the objective of comparing the efficacy of levetiracetam versus valproic acid in pediatric patients with status epilepticus.
Detailed Description
Early and sustained control of seizures is paramount in status epilepticus to save the life of the patient, and this warrants the use of the best drug based on evidence. Identifying a better drug in status epilepticus would add to the local data and help clinicians in making evidence-based decisions to opt for an appropriate treatment in case of failed response to benzodiazepines.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any gender
- •Aged 2-14 years
- •Presenting with status epilepticus
Exclusion Criteria
- •Patients with focal seizures
- •Patients already using valproic acid or levetiracetam
- •Patients with a history of hypersensitivity to either drug
Arms & Interventions
Levetiracetam group
In this group, patients were treated with intravenous levetiracetam (LEV) 20 mg/kg over 15 minutes, followed by 60 mg/kg/day in two divided doses over 24 hours.
Intervention: Levetiracetam (Drug)
Valproic acid group
Patients received intravenous valproic acid at 15 mg/kg over 15 minutes, followed by 20 mg/kg/day in two divided doses over 24 hours.
Intervention: Valproic acid (Drug)
Outcomes
Primary Outcomes
Sustained control of seizure activity
Time Frame: 24 hours
Sustained control was labeled when there was no seizure activity on EEG and regain of consciousness for ≥ 24 hours
Secondary Outcomes
- Immediate cessation of seizure activity(30 minutes)