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COMPARING TWO ANTIEPILEPTIC DRUGS FOR EARLY ONSET SEIZURE PROPHYLAXIS IN HEAD INJURY PATIENTS

Comparing Phenytoin and Fosphenytoin for early onset seizure prophylaxis in head injury patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019878
Enrollment
100
Registered
2019-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: V20-V29- Motorcycle rider injured in transport accident

Interventions

Control Intervention1: Phenytoin and Fosphenytoin: Phenytoin 5mg/kg/Day in 3 divided doses for seven days. Fosphenytoin 5mg PE (phenytoin equivalent) /kg/Day in 3 divided doses for seven days

Sponsors

Institute of Medical Sciences BHU
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: PATIENT WITH HEAD INJURY ADMITTED TO ICU

Exclusion criteria

Exclusion criteria: 1) Age 65years 2) Patients having seizure before administration of studying drugs. 3) Pregnant and lactating female 4) Hepatic and renal failure patients 5) H/O allergic to phenytoin and fosphenytoin. 6) Prior H/O seizure disorder 7) Other anti convulsive and psychotic therapies 8) Acute CNS pathology (Meningitis and Abcess) 9) Acute metabolic derangement (hyponatremia and hypocalcemia) 10) Chronic alcoholic 11) Previous Neurosurgery

Design outcomes

Primary

MeasureTime frame
Observing 1) Incidence of early onset seizure activity within seven days and 2)Time of onset of seizure ( time since drug administration to occurrence of seizure)Timepoint: Daily for seven days in selected patients since drug administration

Secondary

MeasureTime frame
Assessing side effects of Phenytoin and Fosphenytoin while observing studiesTimepoint: Within three months of time limit

Countries

India

Contacts

Public ContactSIVA KUMAR

IMS- BHU

ghanshyambhu1976@gmail.com9838894169

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026