Comparison of clinical efficacy and safety of injectable Levetiracetam versus Phenytoi
Phase 4
- Conditions
- Generalized convulsive status epileptics..Other status epilepticus
- Registration Number
- IRCT20170614034526N2
- Lead Sponsor
- Children Hospital and institute of Child Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 650
Inclusion Criteria
Male and Female Patients aged one to 14 years.
Patients with generalized convulsive status epilepticus, not responding to two doses of diazepam (0.2 mg/kg) given 5 minutes apart.
Parents /guardians of children willing to give Written informed consent.
Exclusion Criteria
Children received anticonvulsant treatment other than benzodiazepine for the acute management of CSE.
Children on assisted ventilation
Children with CSE secondary to hypertensive encephalopathy, head injury, chronic kidney or liver disease and electrolyte derangement (hypoglycemia, hypocalcaemia, hypo/hypernatremia, hypomagnesaemia)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: cessation of seizures. Timepoint: within 30 minutes of administration. Method of measurement: Visual Inspection.
- Secondary Outcome Measures
Name Time Method Safety: •Respiratory depression •Cardiac depression •Hypotension •Central nervous system (CNS) depression. Timepoint: From administration of study drug till the patient under monitoring for acute condition. Method of measurement: Monitoring was done by base line arterial blood gases, electrocardiogram, blood pressure and Glasgow coma scale.