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Background: With regards to the importance of traumatic brain injury (TBI) and its high incidence rate in Iran as well as its severe consequences, it is important to determine the safety and efficiency of modafinil to increase the level of consciousness in hospitalized TBI patients. Methods: This double-blind randomized controlled trial was done during 2016. Sixty patients with TBI and moderate GCS score between 9 and 13 had the inclusion criteria and entered the study and were divided into two groups. Patients in the treatment group received 200 mg of modafinil once a day and the control group received the placebo. Overall, 24 hours after admission, defined as base day, modafinil was prescribed for 196 hours after admission and GCS scores were recorded: this period was defined as the last day. Level of consciousness in both treatment and control groups was assessed by the GCS score. Data were analyzed by SPSS version 21 software using the independent t-test with intention-to-treat approach. Results: Among 60 patients, there were 34 (56.66%) males and 26 (43%) females; 45 (75%) survived. The ITT analysis was employed to assess changes in the level of consciousness (LOC) after prescribing modafinil and placebo. Based on the findings, modafinil prescription was not associated with significant differences in LoC in the first time period (24 hours after) and the last day (196 hours) (P > 0.05). Conclusions: Prescribing modafinil was not associated with significant changes in LoC in comparison with the placebo.

Effect of Modafinil Administration on the Level of Consciousness in Patients with Brain Injuries of Moderate Severity