Objectives: To determine the effectiveness and efficacy of propranolol in the treatment of severe agitation among individuals with traumatic brain injuries (TBI). Hypothesis: We expected that family caregivers would report less agitation among patients receiving propranolol, and these ratings would be significantly lower than observational ratings provided by caregivers during the initial "wash-in" period and during placebo. Participants: Five women and 12 men with TBI who had Agitation Behavior Scale (ABS) scores more than 25 at baseline participated (M age = 33.06, SD = 9.98; 16 Caucasian, 1 black); caregivers included 14 women and 3 men (M age = 52.12, SD = 10.3). Methods: A double-blinded, crossover design was used. Caregivers were trained to rate agitation weekly. Patients had a 2-week "wash-in" before random assignment to treatment or placebo. After 8 weeks, participants crossed over to either the treatment or the placebo. In the first 4 weeks of treatment, participants received initial dosages of 60 mg and participants received up to 80 mg. Results: Paired t test results indicated that caregivers reported a significant decrease in ABS scores from baseline (M = 32.06) through the "wash-in" period (M = 26.88). Significant decreases occurred for the 3 ABS subscales. No further significant decrease in ABS score was noted following the initiation of treatment. Ratings did not vary by caregiver depression. Conclusions: These data, obtained from a small sample of participants, indicate that propranolol may not be an effective treatment for agitation following TBI. Family and patient focus on agitation may have influenced lower ratings or an actual decrease in the expression of agitation. Training family members in recognizing agitation may represent an alternative to medication in milder cases of agitation.
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