IRCT20170614034526N2
Completed
Phase 4
Comparison of clinical efficacy and safety of injectable Levetiracetam versus Phenytoin as second line drug in the management of generalized convulsive status epilepticus in children: An open label randomized control trial
Children Hospital and institute of Child Health0 sites650 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Children Hospital and institute of Child Health
- Enrollment
- 650
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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