Health Condition 1: G405- Epileptic seizures related to external causes
Conditions
Interventions
Intervention1: Phenytoin: The Phenytoin group will be given a loading dose of phenytoin 20 mg/kg intravenously (maximum, 2 gm) at 50 mg per minute and then started on a maintenance dose (5-6 mg/kg/d,
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Patients of severe blunt TBI with GCS score less than 10. Patients with GCS of more than 10 in the presence of computed tomographic imaging findings consistent with brain injury. Patients with penetrating injury.
Exclusion criteria
Exclusion criteria: 1.Females of childbearing age with urine pregnancy test positive. 2.Devastating brain injury with expected or confirmed brain death within 48 hours of hospital admission, 3.Prehospital use of anticonvulsants 4.Development of seizures before enrolment. 5.Any risk factor for Post-Traumatic Seizures like Liver Disease, Renal failure, drugs lowering seizure threshold, severe depression {have undergone or may need Electro Convulsive Therapy(ECT)}
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the incidence of early clinical seizure in each of the three treatment groups.Timepoint: 7 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Glasgow Coma Scale & Glasgow Outcome Scale in the three treatment groups.Timepoint: 7 days and 6 months;To evaluate the effect of genetic polymorphisms on seizure incidence among study participants.Timepoint: 7 days, 6 months and 1 year;Incremental Cost-effective analysis between phenytoin and levetiracetam.Timepoint: 6 months and 1 year | — |
Countries
India
Contacts
Public ContactDr Shoban Babu Varthya
All India Institute Of Medical Sciences, Jodhpur
Outcome results
None listed