Health Condition 1: G049- Encephalitis, myelitis and encephalomyelitis, unspecified
Conditions
Interventions
Intervention1: Group A (phenytoin arm): Intravenous phenytoin 20 mg/kg over 20 minutes followed by an initial maintenance dose of 5 mg/kg/day in two divided doses, later on, the dose will be titrated
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children with Acute Encephalitis Syndrome with 2. History of Acute symptomatic seizures/seizure occurrence after hospitalization/other indication for anti-epileptic drug administration. 3. Parents giving informed consent.
Exclusion criteria
Exclusion criteria: 1. Children with past history of seizures, previous occurrence of focal neurological deficit, or abnormal developmental history before the seizure episode. 2. Children with HIV, Chronic Liver disease, Chronic Kidney disease, acute hepatic encephalopathy. 3. Received any anti-epileptic drug previously. 4. Any specific contraindication/allergy for Phenytoin/ Levetiracetam. 5. Refusal to consent by the caregiver.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the proportions of children aged 1 month to 18 years with Acute Encephalitis Syndrome, who achieved seizure control with phenytoin and levetiracetam during the initial seven days of admission.Timepoint: Initial seven days of admission | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Proportion of children requiring mechanical ventilation and duration of mechanical ventilation in these children in both arms.Timepoint: In initial seven days;1. The difference in the proportions of children who achieved seizure control with phenytoin and levetiracetam during the 12 weeksâ?? follow-up.Timepoint: 12 weeks;3. Proportion of children requiring additional antiepileptic drugs in both arms.Timepoint: In initial seven days;4. Proportion of children with an occurrence of status epilepticus after administration of study drug in both arms.Timepoint: In initial seven days;5. Difference between in-hospital mortality in both arms.Timepoint: In initial seven days;6. Difference between the rate of adverse events in both armsTimepoint: In initial seven days;7. Difference between functional outcome at 1 week, 4 weeks, and 12 weeks, as measured by PCPC, POPC, and GOS-ETimepoint: at 1, 4 and 12 weeks | — |
Countries
India
Contacts
Public ContactDr VIGNESH K M
All India Institute of Medical Sciences, Rishikesh
Outcome results
None listed