Ibaraki ER Network Epilepsy Control Trial with LevetIracetam vs. FosphEnytoine
- Conditions
- status epilepticus
- Registration Number
- JPRN-jRCTs031190160
- Lead Sponsor
- Inoue Yoshiaki
- Brief Summary
The efficacy of LEV was similar to that of FPHT for the treatment of adult SE following the administration of diazepam. Since it was associated with fewer serious adverse event, LEV is recommended as a second-line treatment for SE as an alternative to phenytoin/FPHT.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 176
status epilepticus with convulsion, who were transfered by ambulance
The difinition of status epilepticus is as follows; over 5 minutes of continuous seizures, or over 2 minutes discrete seizures between which there is incomplete recovery of consciousness over JCS II-30
exclude non-convulsive seizure
under 20 years old
patients who entried this study in the past
patients in whom informed consent can not be obtained from proxies (If proxies can not be found, the study is performed and the consent is obtained after action.
already intubated patients before treatment
allergy to fosphenytoin or levetiracetam
pregnancy
pseudo-seizure
medical doctor considered inapropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method seizure stop within 30 min from start of study drugs administration
- Secondary Outcome Measures
Name Time Method seizure reccurence within 24 h<br>severe adverse events<br>intubation rate