]>
IRCT2014010112776N3 IRCT 2014-12-28 Shiraz University of Medical Sciences Effects of Methylphenidate on the Acute Management of Patients with Severe and Moderate Traumatic Brain Injury Effects of Methylphenidate on the Acute Management of Patients with Severe and Moderate Traumatic Brain Injury 2014-03-21 anticipated 200 Complete https://irct.ir/trial/12766 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Moderate and Severe Traumatic Brain Injury. Intervention 1: Patients in the treatment(case) group will receive methylphenidate 20 mg/kg per dose PO BID by the second day of admission for two weeks. Intervention 2: Patients in the control group will receive placebo 20 mg/kg per dose PO BID by the second day of admission for two weeks.
public Hosseinali Khalili
Chamran hospital N/S Dept
Shiraz Iran (Islamic Republic of) +98 71 1623 4508 khalilih16@gmail.com Shiraz Neurosciences Research Center scientific Hosseinali Khalili
Chamran hospital N/S Dept.
Shiraz Iran (Islamic Republic of) +98 71 1623 4508 khalilih16@gmail.com Shiraz Neurosciences Research Center Iran (Islamic Republic of) Inclusion Criteria: ages between 16 and 60; having a history of non-penetrating traumatic brain injury with a GCS=6-8 (Severe) and GCS 9-12 (Moderate) without multi organ injury or failure. Exclusion criteria: not agreeing to enter the study; not being able to tolerate nasogastric Feeding; dying in 48 hours of admission; having a history of pre-morbid neurologic disease, psychosis, major affective disorder, developmental disability, ADHD, currently abusing alcohol or recreational drugs. taking psychoactive medications other than anticonvulsants. having systemic diseases that could have affected the results eg. Diabetes or psychiatric problems, pregnancy or likely to become pregnant; mental retardation, behavioral problems, impairments in vision, hearing, or motor function that were severe enough to preclude participation in the research tasks. 16 years 60 years Both Treatment - Drugs Treatment - Drugs Patients in the treatment(case) group will receive methylphenidate 20 mg/kg per dose PO BID by the second day of admission for two weeks. Patients in the control group will receive placebo 20 mg/kg per dose PO BID by the second day of admission for two weeks. Cognitive function. Timepoint: During 3 and 6 months of follow-up. Method of measurement: Using cognitive measuring tests. Lenght of ICU stay. Timepoint: Total ICU treatment duration. Method of measurement: Based on patients' file and record. Lenght of overall hospital stay. Timepoint: Total hospital treatment duration. Method of measurement: Based on patients' file and record. GCS. Timepoint: During 3 and 6 months of follow-up. Method of measurement: GCS specific tests. GOSE. Timepoint: During 3 and 6 months of follow-up. Method of measurement: GOSE specific tests. Disability Rating Score. Timepoint: During 3 and 6 months of follow-up. Method of measurement: DRS specific tests. Shiraz University of Medical Sciences Approved 2010-08-20 Shiraz University of Medical Sciences Vice-chancellor for Research affairs, at 7th floor, Shiraz University of Medical Sciences, Zand Avenue, Shiraz, Iran Shiraz Iran (Islamic Republic of)