A randomized control trial will be conducted in the Department of Neurology, DMCH. Ethical
approval will be obtained from the DMCH ethical review board before the study. After the
selection of the subjects, the nature, purpose, and benefit of the study will be explained to
each subject & their legal attendants in detail. They will be encouraged for voluntary
participation. Informed written consent will be taken from the participants or their legal
attendants. Diagnosis of Status epilepticus will be made according to the criteria of the
ILAE task force on classification of status epilepticus (2015). The history of previous
disease and habits as well as demographics, the type of SE, seizure duration before
treatment, the cause of SE and family history will be recorded. In both groups, height and
body weight were estimated from body habitus, family information, or patient records. Blood
pressure will be measured. BMI will be calculated as weight (kg)height (m)2. In all patients,
neurological assessment will be conducted routinely. Randomized sampling methods will be
applied for selecting study subjects. Randomization will be carried out into two groups.
After that group A will be treated with FHP and group B will be treated with LEV.
Resuscitation and stabilization will be simultaneously performed to ensure airway patency,
oxygen inhalation to prevent cerebral hypoxia, securing intravenous access & maintenance of
blood pressure. Routine laboratory investigations (full blood count, blood glucose,
electrolytes, calcium, magnesium, liver function test & renal function test) will be done.
EEG will be done in all patients.
At first, Diazepam will be intravenously administered at 10 mg to all patients. Then, if SE
(Status Epilepticus) is not controlled within 20 minutes from Diazepam needle time, study
participants will be rapidly randomized and allocated to the FPHT and LEV groups.
In the FPHT group, FPHT at 20 mg/kg (Phenytoin equivalent dose of 15 mg/kg) will be
intravenously administered in 100mL of normal saline at an administration rate not exceeding
3mg/kg/min or 150 mg/min.
In the LEV group, LEV at 60 mg/kg (max dose 4500 mg) will be intravenously administered in
100mL of normal saline at an administration rate of 2-5mg/kg/min or over 10 minutes.
Then, after 30 minutes following FPHT/LEV needle time reassessment of the patient will be
done to determine the outcomes.
If seizures continue after 30 minutes following FPHT/LEV needle time then, other injectable
agents ( e.g- if FPHT given previously, can give LEV intravenously at 60 mg/kg [max dose 4500
mg] or if LEV given previously, can give FPHT intravenously at 20 mg/kg [Phenytoin equivalent
dose of 15 mg/kg] ) will be given to the patient.
If seizures still continue after 30 minutes patient will be transferred to intensive care and
the standard of care will be given according to intensive care unit protocol.
Once status controlled commence maintenance therapy with Levetiracetam 1000-1500 mg IV twice
daily in case of Group-A patient or with FPHT 400 mg/day IV in case of Group-B patient.
Subsequent anti-seizure medications will be given based on seizure semiology, etiology,
electroencephalography (EEG) correlates, and age of the patient.
After the cessation of seizures, electroencephalography (EEG), neuroimaging (CT / MRI brain),
CSF study & other necessary investigations will be performed as needed. FPHT or LEV will be
randomized only for the first administration after diazepam and their subsequent
administration will be not regulated. The primary outcome will be the seizure cessation rate
within 30 minutes of starting administration of the study drug. Secondary outcomes will be
the seizure recurrence rate within 24 hours, which will be confirmed by an apparent seizure
or non-convulsive seizure detected by EEG; the serious adverse event rate throughout the
observational period potentially induced by the study drugs, such as cardiac arrest,
life-threatening arrhythmia, respiratory arrest and hypotension and the intubation rate
within 24hours. All the information will be recorded in a structured data collection sheet.
Patients will be followed up at 30 minutes, 24 hours, and at discharge after receiving
medication and the following outcomes will be assessed: seizure cessation rate, seizure
recurrence rate, intubation rate, all-cause in-hospital mortality, adverse effects of drugs,
and mRS at discharge. All data will be collected, tabulated, and analyzed statistically using
a personal computer and the Statistical Package for Social Science (SPSS) version 26 (IBM,
Chicago, Illinois, USA).