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Trial of Phenytoin and Levetiracetam in Children with Resistant Status Epilepticus

Comparison of the Efficacy of Phenytoin and Levetiracetam in Children with Benzodiazepine-Resistant Status Epilepticus: A Randomized Controlled Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241019063425N1
Enrollment
128
Registered
2025-01-02
Start date
2024-12-30
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

status epilepticus. refractory status epilepticus

Interventions

Intervention 1: Intervention group: Levetiracetam is administered over 5 minutes at a dose of 40 mg/kg, with a maximum dose of 2.5 grams. Following the initiation of injection, the patient is monitore

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 18 Years

Inclusion criteria

Inclusion criteria: Boys or girls aged 6 months to 17 years and 11 months The patient has received two consecutive doses of first-line treatment but continues to experience ongoing status epilepticus.

Exclusion criteria

Exclusion criteria: Patients with known or suspected pregnancy Patients with a known contraindication or allergy to Levetiracetam or Phenytoin Patients with known renal failure (patients undergoing hemodialysis or with renal function below 50% of the expected for their age) Prior administration of a second-line antiepileptic drug before admission to the emergency department Seizures following head trauma Individuals with underlying heart disease

Design outcomes

Primary

MeasureTime frame
The time from the start of drug injection to the cessation of all visible signs of seizure activity, which is defined as the cessation of all rhythmic seizure activity. Timepoint: From the time of drug injection to the end of epileptic status. Method of measurement: using a stopwatch by the therapist.

Secondary

MeasureTime frame
The need for tertiary anticonvulsants to manage seizures after second-line therapy. Timepoint: After failure to respond to second-line therapy. Method of measurement: The number of patients who needed third-line treatment is recorded in each group.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzad Ahmadabadi

Shahid Beheshti University of Medical Sciences

farzadpt@yahoo.com+98 21 2242 9768

Outcome results

None listed

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