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Comparison of clinical efficacy and safety of injectable Levetiracetam versus Phenytoin

Comparison of clinical efficacy and safety of injectable Levetiracetam versus Phenytoin as second line drug in the management of generalized convulsive status epilepticus in children: An open label randomized control trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170614034526N2
Enrollment
650
Registered
2018-09-26
Start date
2014-01-27
Completion date
Unknown
Last updated
2018-11-05

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

Conditions

Generalized convulsive status epileptics.. Other status epilepticus

Interventions

Intervention 1: Intervention group: Group A: Levetiracetam 40mg/kg infused in 15 minutes. Intervention 2: Control group: Group B: Phenytoin 20 mg/kg infused in 30minutes.

Sponsors

Children Hospital and institute of Child Health
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: Male and Female Patients aged one to 14 years. Patients with generalized convulsive status epilepticus, not responding to two doses of diazepam (0.2 mg/kg) given 5 minutes apart. Parents /guardians of children willing to give Written informed consent.

Exclusion criteria

Exclusion criteria: Children received anticonvulsant treatment other than benzodiazepine for the acute management of CSE. Children on assisted ventilation Children with CSE secondary to hypertensive encephalopathy, head injury, chronic kidney or liver disease and electrolyte derangement (hypoglycemia, hypocalcaemia, hypo/hypernatremia, hypomagnesaemia)

Design outcomes

Primary

MeasureTime frame
Efficacy: cessation of seizures. Timepoint: within 30 minutes of administration. Method of measurement: Visual Inspection.

Secondary

MeasureTime frame
Safety: • Respiratory depression • Cardiac depression • Hypotension • Central nervous system (CNS) depression. Timepoint: From administration of study drug till the patient under monitoring for acute condition. Method of measurement: Monitoring was done by base line arterial blood gases, electrocardiogram, blood pressure and Glasgow coma scale.

Countries

Pakistan

Contacts

Public ContactDr. Nuzhat Noureen

Children Hospital and institute of Child Health

drnuzhatrana@gmail.com+92 61 9201431

Outcome results

None listed

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