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IRCT20210619051624N1 IRCT 2021-09-29 Ahvaz University of Medical Sciences Treatment with Oral Diazepam for Prevention of Recurrence of Seizures following DTP and MMR Vaccination Prophylactic treatment with oral diazepam to prevent recurrence of febrile seizures following triple vaccination with DTP and MMR: Randomize Controlled Trial 2021-09-23 anticipated 30 Complete https://irct.ir/trial/58264 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, individuals are randomly divided into two groups based on four random block permutations. Also, in order to prevent confounding factors as well as reduce the bias caused by the opinions of the project guiding researchers, researchers involved in the levels of random sequencing, enrollment in terms of entry and exit criteria, assigning participants to the target groups will work separately, Blinding description: In this clinical trial, patients will be randomly divided into two groups based on a randomly generated table of computer-generated numbers, with one group receiving oral diazepam and the other group (control) receiving only life-saving diazepam anal tube therapy. And will not receive preventive treatment. 3 Febrile seizures. Intervention 1: Intervention group: The group that will be treated with oral diazepam, and in addition to rectal Diazpam tube, Diazepam tablets are received from Sobhan Company at a dose of 1 mg per kg for the first 48 hours of the vaccine injection. Intervention 2: Control group:The group that will only receive life-saving treatment with diazepam rectal tube in case of seizures lasting more than 2 to 5 minutes and will not receive preventive treatment. Yes - There is a plan to make this available What will be shared: Only the results of the whole data are made available to the public When: Starting 9 months after publication To whom: Information is provided to Ahvaz University of Medical Sciences Conditions: The use of data is merely intended to introduce the study and examine how the parameters are measured Where to obtain: Dr. Shahram Nasiri (Project Manager) How to obtain: No use these data in another study Comments:
public Maryam Kordnezhadian
Zeitoon Karmandi, Aboozar Children's Hospital
Ahvaz Iran (Islamic Republic of) 1417561636 +98 61 3444 9003 karami.9926@gmail.com Ahvaz University of Medical Sciences scientific Shahram Nasiri
Zeitoon Karmandi, Aboozar Children's Hospital
Ahvaz Iran (Islamic Republic of) 1417561636 +98 61 3444 9003 nasiri-sh@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Children 6 months to 6 years old who have had a seizure following the vaccine There are no contraindications to vaccination.Patients with immunodeficiency, cancer, and patients taking corticosteroids are not included in the study. 6 months 6 years Both Parental dissatisfaction Remove the vaccine from the patient's immunization schedule for any reason History of oral diazepam allergy Having contraindications for the MMR and DTP vaccines Prevention Prevention Intervention group: The group that will be treated with oral diazepam, and in addition to rectal Diazpam tube, Diazepam tablets are received from Sobhan Company at a dose of 1 mg per kg for the first 48 hours of the vaccine injection. Control group:The group that will only receive life-saving treatment with diazepam rectal tube in case of seizures lasting more than 2 to 5 minutes and will not receive preventive treatment. Numbers of seizure. Timepoint: After vaccination. Method of measurement: By asking parents of patients. Number of fevers. Timepoint: After vaccination. Method of measurement: By asking parents of patients. Ahvaz University of Medical Sciences Approved 2020-12-29 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Jundishapur University of Medical Sciences, Golestan Blvd., Golestan Town Ahvaz Khouzestan Iran (Islamic Republic of)