]>
IRCT20140915019185N3 IRCT 2020-09-22 Mazandaran University of Medical Sciences Evaluation of methylphenidate on level of conciseness and hospital length of stay in patients with severe and moderate acute traumatic brain injury Evaluation of methylphenidate on level of conciseness and hospital length of stay in patients with severe and moderate acute traumatic brain injury 2020-09-22 anticipated 62 Complete https://irct.ir/trial/50682 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocks with multiples of 2 and different sizes based on a table of random numbers:Blocks with a multiple of 2 and different sizes based on the table of random numbers: Individuals with eligibility criteria to enter the study after completing the form of conscious moral satisfaction of the book by block randomization method are assigned to the two groups. Multiple block size of 2 and different In a block, half of the people will be assigned to each of the study groups and the adjustment of the block size is done by randomization software and by an epidemiologist. The mentioned settings are covered for other researchers, Blinding description: The placebo is designed by a pharmacologist. Due to the same shape and time of use of the drug and the placebo, the patient and the therapist do not know the type of drug. 3 moderate and severe brain trauma. Intervention 1: Patients with moderate to severe brain injury and level of consciousness (GCS) between 5 and 12 who do not have surgery for hemorrhagic lesion on CT scan.they will receive methylphenydaye. Intervention 2: Control group:Patients with moderate to severe brain injury and level of consciousness (GCS) between 5 and 12 who do not have SURGERY.they will receive placebo. 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 I will make a decision after starting work and initial feedback
public Kaveh Haddadi
Amir Mazandarani Ave
SARI Iran (Islamic Republic of) 48166-33131 +98 11 3336 1630 k.haddadi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Kaveh Haddadi
Amir Mazandarani Ave
SARI Iran (Islamic Republic of) 48166-33131 +98 11 3336 1630 k.haddadi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Moderate to severe brain damage and level of consciousness (GCS) between 5 and 12 that do not require surgery. 15 years 75 years Both Children under 15 Adults over 75 years Very severe trauma accompanied by especially chest and abdomen Death in the first 48 hours History of untreated heart disease or uncontrolled hypertension Patients with unstable vital signs (fever above 39 degrees - uncontrolled infectious disease - hypotension - acute renal failure and high creatinine ..) Emergency craniotomy S06.2X Diffuse traumatic brain injury Treatment - Drugs Placebo Patients with moderate to severe brain injury and level of consciousness (GCS) between 5 and 12 who do not have surgery for hemorrhagic lesion on CT scan.they will receive methylphenydaye. Control group:Patients with moderate to severe brain injury and level of consciousness (GCS) between 5 and 12 who do not have SURGERY.they will receive placebo. Level of conciseness. Timepoint: the days 2,7 and discharge time. Method of measurement: GCS. Delirium. Timepoint: Day 2 and day 7 and at discharge. Method of measurement: The incidence of delirium is first assessed by the RASS scale for level of consciousness and then by the CAM-ICU scale for delirium. Mazandaran University of Medical Sciences Approved 2020-06-24 Ethics Committee of Mazandaran University of Medical Sciences Amir Mazandarani Imam Khomeini Hospital sari Mazandaran Iran (Islamic Republic of)