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IRCT20200415047090N1 IRCT 2020-07-26 Esfahan University of Medical Sciences prophylactic intravenous or oral levetiracetam and phenytoin in delay post trauma seizure Comparison of prophylactic intravenous or oral levetiracetam and phenytoin in delay post trauma seizure 2020-06-21 anticipated 160 Complete https://irct.ir/trial/47693 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly assign patients, a randomized block allocation method with a volume of 4 patients in each block will be used. The third person independent of the study, based on the random block method, provides a list of 160 randomly coded codes and provides it to the research team along with 160 coded envelopes. Eligible patients enter the list and, based on the numerical code listed in the envelope list, open the code that corresponds to the numeric code listed in the list and inject the encoded drug into the patient, Blinding description: In this study, after explaining the goals to the patient, he is given informed consent. Patients are randomly divided into two groups, but neither group is aware of which group. The researcher does not know which group each patient belongs to. However, the clinical caregiver is aware of the group of patients and uses the drug in accordance with the group in which the patient is placed. N/A Head traumatic injury. Intervention 1: Intervention group: Phenytoin is treated with a loading dose of 20 mg / kg and injection within one hour and a maintenance dose of 5 mg / kg / day, which the patient first receives for 24 to 48 hours after injection and then orally. Intervention 2: Control group: Lothirastam is treated with a 20 mg / kg loading and injection within an hour and a maintenance dose of 10-20 mg / kg / day, which the patient first receives for 24 to 48 hours after the injection and then orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr Mehdi Shafiei
Isfahan University of Medical Sciences, Hezar Jarib St.,
Esfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۶۱ +98 31 3668 0048 Mehdishafiei82@gmail.com Esfahan University of Medical Sciences scientific Dr Mehdi Shafiei
Isfahan University of Medical Sciences, Hezar Jarib St.,
Esfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۶۱ +98 31 3668 0048 Mehdishafiei82@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Head trauma that requires antiretroviral prophylaxis treatment, for example, the patient has hypertensive depression or intracerebral hemorrhage (IntraCerebral Hemorrhage, Intraventricular hemorrhage,Subarachnoid hemorrhage). The patient must be at least 18 years old Sign a written consent to participate in the study 18 years no limit Both Pregnancy Previous history of epilepsy Previous history of seizures after trauma to the head Taking other anticonvulsant drugs G44.3 Post-traumatic headache Treatment - Drugs Treatment - Drugs Intervention group: Phenytoin is treated with a loading dose of 20 mg / kg and injection within one hour and a maintenance dose of 5 mg / kg / day, which the patient first receives for 24 to 48 hours after injection and then orally. Control group: Lothirastam is treated with a 20 mg / kg loading and injection within an hour and a maintenance dose of 10-20 mg / kg / day, which the patient first receives for 24 to 48 hours after the injection and then orally. Intracranial hemorrhage. Timepoint: 7 day. Method of measurement: Patient seizures and other clinical symptoms. Esfahan University of Medical Sciences Approved 2020-05-30 Ethics committee of Esfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib St., Shiraz Gate, Esfahan Isfehan Iran (Islamic Republic of)