]>
IRCT20200608047689N2 IRCT 2021-02-04 Rasht University of Medical Sciences Comparison of the therapeutic effect of Diazepam and Phenobarbital in recurrence of febrile seizure Comparison of the therapeutic effect of parenteral Phenobarbital and oral Diazepam on recurrency of febrile seizure in hospitalized children- A randomized controlled clinical trial 2021-01-27 anticipated 90 Complete https://irct.ir/trial/49503 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be done before the start of the pragram by https://www.sealedenvelope.com considering 30 people in each group (3 groups of Diazepam, Phenobarbital, and control in 2 simple and complex strata) in 6 blocks. Any of them is placed in a separate envelope according to the list obtained from the software and it will be closed and provided to the third person. Patients names will be registered by admission. If the patient comes and is qualifed، the envelope will be opened and based on the expected sequence، he/she will be treated. 3 Febrile seizure. Intervention 1: Intervention group: 1. Intravenous Phenobarbital at a dose of 3 to 5 milligrams per kilogram per day will be divided into two doses that will be administered daily for 3 days at the time of hospitalization.(Phenobarbital is a Barbiturate and from Chemidarou company with 200 milligrams/1 milliliter ampules.). Intervention 2: Intervention group: 2. Oral Diazepam at a dose of 33 milligrams per kilogram three times a day for three days during fever.(Diazepam is a Benzodiazepine and from Chemidarou company with 2 milligrams tablets.). No - There is not a plan to make this available Justification or reason for not sharing IPD is Regarding the ethical issues and confidentiality
public Elham Bidabadi
No. 15- 135 ave.- Golsar
Rasht Iran (Islamic Republic of) 4144654679 +98 13 3372 9104 bidabadi@mail.com Rasht University of Medical Sciences scientific Elham Bidabadi
No. 15- 135 ave.- Golsar
Rasht Iran (Islamic Republic of) 4144654679 +98 13 3372 9104 bidabadi@mail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Parents complete satisfaction with the children's presence in the study Children who experience febrile seizure for the first time 6 months 6 years Both History of any neurological disease Children with previous history of seizure and febrile seizure Imbalance of electrolytes associated with chronic disease R56.0 Febrile convulsions Treatment - Drugs Treatment - Drugs Intervention group: 1. Intravenous Phenobarbital at a dose of 3 to 5 milligrams per kilogram per day will be divided into two doses that will be administered daily for 3 days at the time of hospitalization.(Phenobarbital is a Barbiturate and from Chemidarou company with 200 milligrams/1 milliliter ampules.) Intervention group: 2. Oral Diazepam at a dose of 33 milligrams per kilogram three times a day for three days during fever.(Diazepam is a Benzodiazepine and from Chemidarou company with 2 milligrams tablets.) Recurrence of febrile seizure. Timepoint: The initial outcome will be measured during three days of hospitalization. Method of measurement: The occurrence of any types of seizure. The side effects of the drugs such as lethargy, rash and irritability. Timepoint: In 3 days during hospitalization. Method of measurement: The occurrence of complications. Rasht University of Medical Sciences Approved 2021-01-27 Ethics committee of the vice chancellor of Guilan University of Medical Sciences Siadati street Rasht Guilan Iran (Islamic Republic of)