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A clinical trial to compare two drugs, levetiracetam and valproate in children with seizure.

Levetiracetam versus valproate as second line antiepileptic for management of status epilepticus in chidren.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/034552
Enrollment
100
Registered
2021-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: G409- Epilepsy, unspecified

Interventions

Intervention1: Intravenous midazolam/lorazepam followed by intravenous Valproate: Patients will receive intravenous midazolam/lorazepam 0.1 mg/kg at a rate of 2 mg/min(max 4mg per dose), then randomly

Sponsors

Pandit BDSharma UHSRPGIMS ROHTAK
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 3 years to 14 years with convulsive status epilepticus (clonic, tonic, tonic clonic, focal or generalised) who are neurologically normal prior to current illness will be enrolled.

Exclusion criteria

Exclusion criteria: Acute or chronic liver disease or kidney disease. Children with global developmental delay or intellectual disability. Severe protein energy malnutrition. Patients who have received the study drug prior to presentation in emergency department

Design outcomes

Primary

MeasureTime frame
to measure the proportion of patients in whom status epilepsy was aborted within twenty minutes after infusion started with no recurrence prior to sixty minutes after the start of infusion.Timepoint: 20 minutes 60 minutes

Secondary

MeasureTime frame
any acute adverse event following interventional drug administration.Timepoint: 1 day

Countries

India

Contacts

Public ContactDr Renu Sharma

Pt.B.D.Sharma PGIMS Rohtak

gehlawatv@gmail.com09812768686

Outcome results

None listed

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