]>
IRCT2013120710087N3 IRCT 2014-05-09 Zahedan University of Medical Sciense Comparison between Phenobarbital and Topiramate in prevention of relapse of febrile seizure in patients aged 6months to 5 years suffering from Febrile Convulsion Comparison between Phenobarbital and Topiramate in prevention of relapse of febrile seizure in patients aged 6months to 5 years suffering from Febrile Convulsion 2011-12-11 anticipated 140 Complete https://irct.ir/trial/10564 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Febrile Convulsions. Intervention 1: Intervention group : The patients in the intervention group take 5 mg per kg oral Topiramate per day for a year. To ensure proper use of the drug, the patient is asked to visit the clinic again after 1, 2, and 6 months from the first visit to be evaluated. Patient who cant tolerate the drug due to side effects are excluded from the study. After one year of treatment, patients in both groups are re-examined and after the assessment of the relapse of febrile convulsion, the data is recorded. Intervention 2: Control group: The patients in the control group take 5 mg per kg oral phenobarbital in two divided doses per day for a year. To ensure proper use of the drug, the patient is asked to visit the clinic again after 1, 2, and 6 months from the first visit to be evaluated. Patient who cant tolerate the drug due to side effects are excluded from the study. After one year of treatment, patients in both groups are re-examined and after the assessment of the relapse of febrile convulsion, the data is recorded.
public Dr Ali Khaje
Ali Ebne Abitaleb Hospital
Zahedan Iran (Islamic Republic of) +98 54 1341 1260 khajeha@zaums.ac.ir Zahedan University of Medical Science scientific ِِDr Ali Khaje
Ali Ebne Abitaleb Hospital
Zahedan Iran (Islamic Republic of) +98 54 1341 1260 khajeha@zaums.ac.ir Zahedan University of Medical Science Iran (Islamic Republic of) Inclusion criteria: patients aged 6 months to 5 years suffering from febrile convulsion; if the first febrile convulsion occurs under 1 year of age; positive family history of febrile convulsion in first-degree relatives; low grade fever during the first attack (less than 39 °C); short period of time between the onset of fever and convulsion; multiple attacks of seizure; if the first febrile convulsion is complex. Exclusion criteria: patients who have clinical or radiographic signs due to chronic mental disease (MR); patients who were diagnosed with meningitis considering the LP; patients whose seizure caused by electrolyte imbalance; history of a seizure without high temperature; patients who received prophylaxis treatment; patients who developed side effect due to receiving Topiramate. 1 year 5 years Both R56.0 Febrile convulsions Treatment - Drugs Treatment - Drugs Intervention group : The patients in the intervention group take 5 mg per kg oral Topiramate per day for a year. To ensure proper use of the drug, the patient is asked to visit the clinic again after 1, 2, and 6 months from the first visit to be evaluated. Patient who cant tolerate the drug due to side effects are excluded from the study. After one year of treatment, patients in both groups are re-examined and after the assessment of the relapse of febrile convulsion, the data is recorded. Control group: The patients in the control group take 5 mg per kg oral phenobarbital in two divided doses per day for a year. To ensure proper use of the drug, the patient is asked to visit the clinic again after 1, 2, and 6 months from the first visit to be evaluated. Patient who cant tolerate the drug due to side effects are excluded from the study. After one year of treatment, patients in both groups are re-examined and after the assessment of the relapse of febrile convulsion, the data is recorded. Decreasing the relapse of Febrile Convulsion. Timepoint: After one year. Method of measurement: Clinical assessment. Zahedan University of Medical Sciense Approved 2011-06-13 Zahedan University of Medical Science Dr Hesabi square Zahedan Iran (Islamic Republic of)