Comparison, the Efficacy of Levetireacetam, Phenytoin, Management of Pediatric Status Epilepticus
Conditions
Keywords
Levetireacetam, Phenytoin, status epilepticus, children
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.
Interventions
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.
DRUGPhenytoin 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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Days to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cessation of convulsion | 30 minutes | seizure control based on stoppage of tonic and clonic movements and absence of epileptic activity in EEG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactAmira Darwish, MD
Outcome results
None listed