Rapid Agitation Control With Ketamine in the Emergency Department: A Blinded, Randomized Controlled Trial.

STUDY OBJECTIVE: We hypothesized that the use of intramuscular ketamine would result in a clinically relevant shorter time to target sedation. METHODS: We conducted a randomized clinical trial comparing the rapidity of onset, level of sedation, and adverse effect profile of ketamine compared to a combination of midazolam and haloperidol for behavioral control of emergency department patients with severe psychomotor agitation. We included patients with severe psychomotor agitation measured by a Richmond Agitation Score (RASS) ≥+3. Patients in the ketamine group were treated with a 5 mg/kg intramuscular injection. Patients in the midazolam and haloperidol group were treated with a single intramuscular injection of 5 mg midazolam and 5 mg haloperidol. The primary outcome was the time, in minutes, from study medication administration to adequate sedation, defined as RASS ≤-1. Secondary outcomes included the need for rescue medications and serious adverse events. RESULTS: Between June 30, 2018, and March 13, 2020, we screened 308 patients and enrolled 80. The median time to sedation was 14.7 minutes for midazolam and haloperidol versus 5.8 minutes for ketamine (difference 8.8 minutes [95% confidence interval (CI) 3.0 to 14.5]). Adjusted Cox proportional model analysis favored the ketamine arm (hazard ratio 2.43, 95% CI 1.43 to 4.12). Five (12.5%) patients in the ketamine arm and 2 (5.0%) patients in the midazolam and haloperidol arm experienced serious adverse events (difference 7.5% [95% CI -4.8% to 19.8%]). CONCLUSION: In ED patients with severe agitation, intramuscular ketamine provided significantly shorter time to adequate sedation than a combination of intramuscular midazolam and haloperidol.

Development and preliminary validation of the First Episode Social Functioning Scale for early psychosis.

The current study aimed at developing and conducting a preliminary validation a novel social functioning measure for people with early psychosis. The First Episode Social Functioning Scale (FESFS) was developed to cover many domains specific to this population in their contemporary reality. The self-report version of the FESFS was administered to 203 individuals receiving services in first episode clinics. Scores of the GAF, SOFAS, Social Functioning Scale and BPRS were also obtained for parts of the sample to calculate convergent and discriminant validity. A subgroup also answered the FESFS at several time points during treatment in order to determine sensibility to change. Principal component factor analyses and internal consistency analyses revealed the following nine factors with alphas ranging from 0.63 to 0.80: Friendships and social activities, Independent living skills, Interacting with people, Family, Intimacy, Relationships and social activities at work, Work abilities, Relationships and social activities at school, Educational abilities. Convergent and discriminant validity were demonstrated, as well as sensitivity to change. Clinical and research utility of the FESFS are discussed.