Health Condition 1: G988- Other disorders of nervous system
Conditions
Interventions
Intervention1: Phenytoin, Levetiracetam: There are 2 intervention arms/groups and 1 control arm/group (total 3 groups/arms) in this study. The intervention arm uses prophylactic AEDs - one arm will re
Sponsors
All India Institute of Medical Sciences Raipur
Dr Anil Kumar Goel
Dr Tushar Bharat Jagzape
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children presenting to the Pediatric Emergency Medicine Unit with clinical findings consistent with raised ICP and not had h/o seizures. 2. Children already loaded elsewhere prophylactically, with appropriate standard dosing (as used in the study) of Levetiracetam/ Phenytoin and referred here; with findings consistent with raised ICP in PEM shall also be included in the concerned anti-epileptic drug arm and observed further with the maintenance dose.
Exclusion criteria
Exclusion criteria: 1. Known seizure disorder/ epilepsy on regular antiepileptic therapy (Those children meeting the criteria, with only febrile seizures on intermittent AED prophylaxis, will not be excluded). 2. Children with ICP who already had seizures. 3. Post cardiac arrest/ history of CPR.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of occurrence of acute symptomatic seizures (ASS; including Non-Convulsive Status Epilepticus) in 48 hours from admission within the 3 groups. 2. Incidence of 48 hours mortality & reduction of 48 hours predicted mortality index from baseline prediction at admission based on PRISM 3 scores in the 3 study groups. Timepoint: 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Seizure recurrence/ occurrence after 48 hours till discharge from the hospital/ during 1 month follow up period in 3 groups 2. Outcome analysis to be done at 7 days and 1 month in 3 study groups by means of survival analysis. 3. Efficacy of Phenytoin v/s Levetiracetam in reducing the mortality at 48 hours and morbidity patterns at 48 hours & 7 days/ till discharge from the hospital whichever is earlier, as subgroup analysis in the treatment groups. 4. Occurrence of potential side effects of the AEDs and the impact of the same with morbidity/ hospital stay in the treatment groups. 5. Rate of dose increment events among both treatment groups. Timepoint: 1 month | — |
Countries
India
Contacts
Public ContactJOVIN CHRIS ANTONY
All India Institute of Medical Sciences, Raipur
Outcome results
None listed