Efficacy Comparison Between Levetiracetam and Valproic Acid in Pediatric Patients With Status Epilepticus

Comparison Between Efficacy of Levetiracetam Versus Valproic Acid in Pediatric Patients With Status Epilepticus

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07052136

Enrollment

138

Registered

2025-07-04

Start date

2024-11-01

Completion date

2025-04-30

Last updated

2025-07-04

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

Conditions

Status Epilepticus

Brief summary

Since there is a significant degree of variability in the results of previous studies and there exists a thirst for local data regarding this topic, the current study was planned, with the objective of comparing the efficacy of levetiracetam versus valproic acid in pediatric patients with status epilepticus.

Detailed description

Early and sustained control of seizures is paramount in status epilepticus to save the life of the patient, and this warrants the use of the best drug based on evidence. Identifying a better drug in status epilepticus would add to the local data and help clinicians in making evidence-based decisions to opt for an appropriate treatment in case of failed response to benzodiazepines.

Interventions

DRUGLevetiracetam

Patients were treated with intravenous levetiracetam (LEV) 20 mg/kg over 15 minutes, followed by 60 mg/kg/day in two divided doses over 24 hours.

DRUGValproic acid

Patients received intravenous valproic acid at 15 mg/kg over 15 minutes, followed by 20 mg/kg/day in two divided doses over 24 hours.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 14 Years

Healthy volunteers

Inclusion criteria

* Any gender * Aged 2-14 years * Presenting with status epilepticus

Exclusion criteria

* Patients with focal seizures * Patients already using valproic acid or levetiracetam * Patients with a history of hypersensitivity to either drug

Design outcomes

Primary

Measure	Time frame	Description
Sustained control of seizure activity	24 hours	Sustained control was labeled when there was no seizure activity on EEG and regain of consciousness for ≥ 24 hours

Secondary

Measure	Time frame	Description
Immediate cessation of seizure activity	30 minutes	Immediate cessation was defined as cessation of seizure activity within 15-30 minutes, after completion of drug infusion.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026