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

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 ۲۰۱۶. Sixty patients with TBI and moderate GCS score between ۹ and ۱۳ had the inclusion criteria and entered the study and were divided into two groups. Patients in the treatment group received ۲۰۰ mg of modafinil once a day and the control group received the placebo. Overall, ۲۴ hours after admission, defined as base day, modafinil was prescribed for ۱۹۶ 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 ۲۱ software using the independent t-test with intention-to-treat approach.Results: Among ۶۰ patients, there were ۳۴ (۵۶.۶۶%) males and ۲۶ (۴۳%) females; ۴۵ (۷۵%) 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 (۲۴ hours after) and the last day (۱۹۶ hours) (P > ۰.۰۵).Conclusions: Prescribing modafinil was not associated with significant changes in LoC in comparison with the placebo.

Keywords:

Modafinil , Level of Consciousness , Glasgow coma scale , Traumatic Brain Injury