Health Condition 1: G049- Encephalitis, myelitis and encephalomyelitis, unspecified
Conditions
Interventions
Intervention1: Arm A (early switch over of antiepileptic drugs to oral route ): Category 1: Only one seizure in the last 24 hours, nostatus epilepticus, required one AED to control seizure:-Immediatel
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged between 1 month-18 years, presented to paediatric emergency/ward/OPD with at least one episode of clinical seizure 2. At least one episode of seizure during the hospital stay 3. Requires at least one dose of intravenous antiepileptic drug 4. Able to receive and tolerate medications via oral or gastric feeding tube route 5. Able to receive and tolerate a diet or enteral feeding (via gastric feeding tube)
Exclusion criteria
Exclusion criteria: 1. Clinical suspicion of Non Convulsive Status Epilepticus (Salzburg criteria), but EEG has not ruled out NCSE 2. Refractory nausea, vomiting and/or diarrhea in the last24 hours 3. Use of a feeding tube that terminates distal to the stomach (e.g. jejunal tube) 4. Active gastrointestinal bleeding 5. Any other physical condition, likely to increase risk of aspiration on oral ingestion, impair absorption, first-pass metabolism or bioavailability 6. Caregiver not providing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of children with seizure recurrence within one week from last seizure freedom in both armsTimepoint: One week | — |
Secondary
| Measure | Time frame |
|---|---|
| Behavioral upset in medical patients-revised hospital scale in children in both armsTimepoint: During first week;Children’s Global Assessment Scale (CGAS) at one week in both armsTimepoint: One week;Comparison of the frequency of each adverse event between both armsTimepoint: Till 3 months of starting AEDs;Duration of hospital stay in days in both armsTimepoint: Total hospital duration;Serum AED trough levels at 24-hour intervals till discharge, starting from 24 hours after seizure freedom for category 1 and 48 hours for rest of the categoriesTimepoint: 24 hours after seizure freedom for category 1 and 48 hours for rest of the categories;Short assessment of patient satisfaction score, clinical global impression-improvement and efficacy index done one week in both armsTimepoint: One week;The proportion of children with seizure recurrence in the last 3 months from last seizure freedom in both armsTimepoint: 3 months;The proportion of children with status epilepticus within one week from last seizure freedom in both armsTimepoint: One week | — |
Countries
India
Contacts
Public ContactDr Sanjot Bhardwaj
All India Institute of Medical Sciences, Rishikesh
Outcome results
None listed