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IRCT20241019063425N1 IRCT 2025-01-02 Shahid Beheshti University of Medical Sciences 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 2024-12-30 anticipated 128 Complete https://irct.ir/trial/80290 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Double-blinding is not feasible due to the difference in the infusion durations of these two drugs. A random sequence prepared in advance, using blocks of 2, 4, and 8, is generated through simple randomization and used to assign each patient to a treatment. Patients are entered into the random sequence based on the order of their arrival. 3 status epilepticus. 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 monitored by the resident for the cessation of SE symptoms, and when possible, a video recording is made to document the exact time SE ends. During SE treatment, the APLS algorithm is always followed, and emergency measures (e.g., intubation) are performed if necessary. Intervention 2: Intervention group: Phenytoin is administered over a minimum of 20 minutes at a dose of 20 mg/kg, with a maximum dose of 2 grams and an infusion rate of no more than 1 mg/kg/min. If one medication does not result in a response, the patient is reevaluated, and the persistence of SE is confirmed before initiating another medication. For instance, if the patient does not respond to phenytoin, levetiracetam will be started. The response to phenytoin is assessed up to 25 minutes after initiation, while the response to levetiracetam is evaluated up to 10 minutes after the start of infusion. Patients' outcomes are documented accordingly. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Farzad Ahmadabadi
Mofid Hospital, Shariati Street, Tehran
Tehran Iran (Islamic Republic of) 196151178 +98 21 2242 9768 farzadpt@yahoo.com Shahid Beheshti University of Medical Sciences scientific Farzad Ahmadabadi
Mofid Hospital, Shariati Street, Tehran
Tehran Iran (Islamic Republic of) 196151178 +98 21 2242 9768 farzadpt@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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. 6 months 18 years Both 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 G40.301 refractory status epilepticus Treatment - Drugs Treatment - Drugs 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 monitored by the resident for the cessation of SE symptoms, and when possible, a video recording is made to document the exact time SE ends. During SE treatment, the APLS algorithm is always followed, and emergency measures (e.g., intubation) are performed if necessary. Intervention group: Phenytoin is administered over a minimum of 20 minutes at a dose of 20 mg/kg, with a maximum dose of 2 grams and an infusion rate of no more than 1 mg/kg/min. If one medication does not result in a response, the patient is reevaluated, and the persistence of SE is confirmed before initiating another medication. For instance, if the patient does not respond to phenytoin, levetiracetam will be started. The response to phenytoin is assessed up to 25 minutes after initiation, while the response to levetiracetam is evaluated up to 10 minutes after the start of infusion. Patients' outcomes are documented accordingly. 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. 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. Shahid Beheshti University of Medical Sciences Approved 2024-10-12 The specialized committee of ethics in biomedical research Shahid Beheshti University of Medical Sciences and Health Services, University Headquarters, Building No. 2, 6th Floor, Arabi Street, Yemen Street, Shahid Chamran Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)