A Study to compare the benefits of sodium valproate with levetiracetam and phenytoin in reducing restlessness in brain injury patients.

A Prospective Observational Study to evaluate the efficacy of sodium valproate in comparison with levetiracetam and phenytoin in attenuating severity of agitation in Traumatic Brain Injury patients at a tertiary care hospital.

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/01/049333

Enrollment

272

Registered

2023-01-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

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

Conditions

Health Condition 1: S06- Intracranial injury

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adults age group (18-65) 2.Patients with post traumatic brain injury who are willing to get admitted and give informed consent.

Exclusion criteria

Exclusion criteria: 1.Children below 18yrs and elderly above 65yrs. 2.Pregnant and lactating women. 3.Traumatic brain injury patients who require surgical interventions. 4.Epileptic patient. 5.All neurodegenerative cases. E.g. -Alzheimerâ??s disease, Parkinsonâ??s etc. 6.H/O Drug addiction or Drug abuse 7.H/O Psychotic disorders or on any Antipsychotic medications.

Design outcomes

Primary

Measure	Time frame
1. A) Percentage of patients with -no agitation in Sodium valproate group as compared to levetiracetam. B) Percentage of patients with mild agitation of RAS Score â?¤2 in Sodium valproate group as compared to levetiracetam. C) Percentage of patients with severe agitation of RAS Score â?¥2 in Sodium valproate group as compared to levetiracetam. 2.A) Percentage of patients with- no agitation in Sodium valproate group as compared to phenytoin. B) Percentage of patients with mild agitation of RAS Score â?¤2 in Sodium valproate group as compared to phenytoin. C) Percentage of patients with severe agitation of RAS Score â?¥2 in Sodium valproate group as compared to phenytoin. Timepoint: Daily Day 1 to Day 7.	—

Measure

Time frame

1. A) Percentage of patients with -no agitation in Sodium valproate group as compared to levetiracetam. B) Percentage of patients with mild agitation of RAS Score â?¤2 in Sodium valproate group as compared to levetiracetam. C) Percentage of patients with severe agitation of RAS Score â?¥2 in Sodium valproate group as compared to levetiracetam. 2.A) Percentage of patients with- no agitation in Sodium valproate group as compared to phenytoin. B) Percentage of patients with mild agitation of RAS Score â?¤2 in Sodium valproate group as compared to phenytoin. C) Percentage of patients with severe agitation of RAS Score â?¥2 in Sodium valproate group as compared to phenytoin. Timepoint: Daily Day 1 to Day 7.

—

Secondary

Measure	Time frame
1. Pattern of adverse effects due to additional drugs prescribed for agitation. As per the ADR form. 2. Extra cost towards hospitalization, consultation, bed charges, nursing charge, drug cost 3. Reduction in length of hospital stay.Timepoint: Daily Day 1 to Day 7 or till the Date of Discharge.	—

Countries

India

Contacts

Public ContactDr SHIVANI SINGH

KASTURBA MEDICAL COLLEGE, MANIPAL, MANIPAL ACADEMY OF HIGHER EDUCATION

shivani.180singh@gmail.com8485056848

Outcome results