Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus
Phase 4
- Conditions
- Management of Pediatric Status EpilepticusComparisonthe Efficacy of LevetireacetamPhenytoin
- Interventions
- Registration Number
- NCT04176887
- Lead Sponsor
- Tanta University
- Brief Summary
The study will be conducted on 60 children suffering from status epilepticus who will be admitted to Pediatric Neurology Unit and Pediatric ICU of Tanta Hospital University.
- Detailed Description
The aim of this work is to compare the efficacy of Levetireacetam and Phenytoin in management of pediatric status epilepticus.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Children suffering from convulsive generalized tonic clonic status epilepticus at any age.
Exclusion Criteria
- Non convulsive status epilepticus.
- Children with known contraindication or allergy to levetireacetam or phenytoin.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levetiracetam Levetiracetam Injection The levetiracetam dose is 20- 40 mg/kg by intravenous infusion over 15 minute, a rate of 2-5 mg/kg/minute diluted in 100 ml with 0.9% sodium chloride as a single dose. Phenytoin Phenytoin Injection Phenytoin dose is 20-40 mg/kg/min by intravenous infusion over 30 minute, diluted with 0.9% sodium chloride to a maximum concentration of 10 mg/ml.
- Primary Outcome Measures
Name Time Method cessation of convulsion 30 minutes seizure control based on stoppage of tonic and clonic movements and absence of epileptic activity in EEG
- Secondary Outcome Measures
Name Time Method bradycardia 6 hours monitoring of heart rate
respiratory depression 6 hours monitoring of respiratory rate
decreased conscious level 6 hours Glasgow Coma Score
hypotension 6 hours measurement of blood pressure
Trial Locations
- Locations (1)
Tanta University, Faculty of Medicine
🇪🇬Tanta, Gharbia, Egypt