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IRCT2013071514001N1 IRCT 2013-08-09 Research and Thecnology Deputy, Golestan University of Medical Sciences comparison diazepam and clobazam in prevention recurrence of febrile seizure A comparative study of diazepam and clobazam in prevention recurrence of febrile seizure in children with age range of 6 month to 6 years of old admitted to Gorgan Taleghani hospital in 2011-2012 2011-11-06 anticipated 280 Complete https://irct.ir/trial/13701 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 febrile seizure. Intervention 1: Treatment by diazepam Chemical composition: 7-chloro-1,3-dihydro-1-methyl-5-phenyl-1-benzodiazepin-, C16H13ClN2O , molecular weight: 284.7 Dosage: 0.33 mg/kg Frequency of drug use: 3 times per day Duration of drug use: 48 hours. Intervention 2: Treatment by clobazam Chemical composition: Chloro-1-methyl-5-phenyl-1,5-benzodiazepine, C16H13ClN2O2 , molecular weight: 300.74 Dosage: 2.5 mg for Children weighing less than 5 kg 5 mg for Children weighing 6-10 kg 7.5 mg for Children weighing 11- 15 kg 10 mg for Children weighing more than 15 kg Frequency of drug use: 2 times per day, every 12 hours Duration of drug use: 48 hours.
public Mahdi Jalili Akbarian
Taleghani Hospital, Janbazan Boulevard
Gorgan Iran (Islamic Republic of) +98 17 1222 7721 drmja2007@yahoo.com Golestan University of Medical Sciences scientific Sepodeh Amouian
Taleghani Hospital, Janbazan Boulevard
Gorgan Iran (Islamic Republic of) +98 17 1222 7721 amoian_sep@yahoo.com Golestan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria includes patients with simple febrile seizure that their parents worry about recurrence of febrile seizure or live away medical centers and have no access to medical facilities and also children that have multiple caregiver. Exclusion criteria includes: 1) patients that have no generalized seizure or have focal signs and seizure takes more than 15 minutes and occurs more than one time in 24 hours, neurological abnormalities and abnormal neurologic examination and developmental disorders; 2) progressive neurological disease; 3) seizures during infection of the central nervous; 4) diagnosis is not febrile seizure and there are other causes and 5) abnormal EEG. 6 years 72 years Both R56.0 Febrile convulsions Treatment - Drugs Treatment - Drugs Treatment by diazepam Chemical composition: 7-chloro-1,3-dihydro-1-methyl-5-phenyl-1-benzodiazepin-, C16H13ClN2O , molecular weight: 284.7 Dosage: 0.33 mg/kg Frequency of drug use: 3 times per day Duration of drug use: 48 hours Treatment by clobazam Chemical composition: Chloro-1-methyl-5-phenyl-1,5-benzodiazepine, C16H13ClN2O2 , molecular weight: 300.74 Dosage: 2.5 mg for Children weighing less than 5 kg 5 mg for Children weighing 6-10 kg 7.5 mg for Children weighing 11- 15 kg 10 mg for Children weighing more than 15 kg Frequency of drug use: 2 times per day, every 12 hours Duration of drug use: 48 hours Recurrence of seizure. Timepoint: Every 3 months iduring intervention. Method of measurement: mg/kg. Drug side effects. Timepoint: Every 3 monthes during intervention. Method of measurement: By asking parents. Research and Thecnology Deputy, Golestan University of Medical Sciences Approved 2011-11-06 Research and Thecnology Deputy, Golestan University of Medical Sciences Falsafi Higher Education Bilding, beginning of Shastkola roade, Gorgan Iran (Islamic Republic of)