Does sodium valproate reduce delirium after head injury?

A randomized trial comparing the effect of sodium valproate with phenytoin for traumatic brain injury induced delirium when used as a prophylactic antiepileptic.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/03/008058

Enrollment

128

Registered

2017-03-10

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: null- Adult patients with Traumatic Brain Injury

Interventions

Intervention1: Sodium valproate: As per existing protocols in the management of traumatic brain injury. Dose:Sodium valproate 20-30 mg/kg/day in 3 divided doses Route: IV until oral intake possible Du

Eligibility

Inclusion criteria

Inclusion criteria: i. All admitted patients with traumatic brain injury ii. >= 18 years of age

Exclusion criteria

Exclusion criteria: i. Pregnant patients ii. Any other associated skeletal trauma (may cause pain and therefore agitation): long bone injuries, pelvic fractures, chest trauma or maxillofacial injuries iii. Glasgow Coma Scale score of 5 or less (chance of mortality high, and even survivors may have too low a sensorium to be agitated) iv. Patients with seizure disorder

Design outcomes

Primary

Measure	Time frame
Incidence of agitation in the valproate group when compared to the phenytoin group as measured using the Agitated Behaviour Scale (ABS). Timepoint: The ABS will be assessed three times a day from day 3 of admission until discharge.	—

Secondary

Measure	Time frame
Use of other drugs used to control agitation is reducedTimepoint: At the time discharge	—

Countries

India

Contacts

Public ContactMadhurita Singh

Christian Medical College

madhurita@cmcvellore.ac.in04162282693

Outcome results

None listed

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