IRCT20160523028008N23.
| Study name | The effect of levetiracetam and phenobarbital on the control of neonatal seizures |
| Methods | Randomised controlled trial |
| Participants | Term neonates with seizures (clinical diagnosis) |
| Interventions | Intervention 1: Intervention group: Patients are treated with levetiracetam injection (500 mg/5 mL by Estragen Company, Switzerland) at a loading dose of 50 mg/kg and infusion rate of 2 mg/kg/min (within 10 cc of normal saline) under cardiorespiratory monitoring. If seizures continue with the first dose of levetiracetam, the drug is re‐loaded at a dose of 50 mg/kg at the same infusion rate (within 10 cc of normal saline). If the seizure does not stop or returns after 15 minutes, even after the second dose of medication, the treatment groups are changed. If the seizure does not stop or returns after 15 minutes after changing treatment groups, other anticonvulsant drugs are used. Intervention 2: Control group: Patients in the control group are treated with phenobarbital injection (200 mg/mL from Chemidarou company) at a loading dose of 20 mg/kg and at an infusion rate of 1 m/kg/min (within 10 cc of normal saline) under cardiorespiratory monitoring. If the seizure continues with the first dose, phenobarbital is re‐loaded by infusion at a dose of 20 mg per kg at the same rate as before. If the seizure does not stop or returns after 15 minutes, even after the second dose of medication, the treatment groups are changed. If the seizure does not stop or returns after 15 minutes after changing treatment groups, other anticonvulsant drugs are used. |
| Outcomes | Complete cessation of seizures for 24 hours after medication. Time point: in the first 24 hours after medication. Method of measurement: stopping seizure movements clinically (clinical assessment Number of doses received to stop seizures. Time point: in the first 24 hours after medication. Method of measurement: patient medical record |
| Starting date | |
| Contact information | naderfaraji59@gmail.com |
| Notes | Clinical diagnosis of seizures and assessment of treatment success |