Baclofen can reduce agitation in ICU patients

Critically ill patients who exhibit symptoms of unhealthy alcohol use can become agitated when receiving mechanical ventilation in the ICU. A study published in the February 23, 2021 issue of JAMA showed that high-dose baclofen can prevent alcohol withdrawal–related agitation.

More than 300 patients participated in a Phase III double-blind, placebo-controlled, randomized clinical trial conducted in 18 ICUs in France between June 2016 and February 2018. Patients were treated with baclofen, adjusted from 50 mg to 150 mg per day based on estimated glomerular filtration rate, or placebo during mechanical ventilation up to a maximum of 15 days before gradual dose reduction over 3 to 6 days.

The primary endpoint was the percentage of patients with at least one agitation-related event during the treatment period. Secondary outcomes included duration of mechanical ventilation, length of ICU stay, and 28-day mortality.

During the study, 19.7% of patients receiving baclofen experienced an agitation-related event, compared with 29.7% in the placebo group. Of 18 prespecified secondary endpoints, 14 were not significantly different between the two groups. However, the baclofen group had a significantly longer median length of mechanical ventilation (9 vs. 8 days) and stay in the ICU (14 vs. 11 days).

At 28 days, there was no significant difference in mortality in the baclofen group compared with the placebo group, but delayed awakening occurred in 14 patients (8.9%) in the baclofen group versus 3 patients (1.9%) in the placebo group.

The authors concluded that although high-dose baclofen significantly reduced agitation-related events, further research is needed to determine the possible role of baclofen in treating this patient population given the modest effect and totality of findings for secondary endpoints and adverse events.