Comparison of the incidence of recovery agitation with two different doses of ketamine in procedural sedation: A randomized clinical trial.

Objectives: The objective was to compare the incidence of recovery agitation and efficacy of two different intravenous (IV) doses of ketamine (0.5 mg/kg vs. 1 mg/kg) in adult patients who presented to the emergency department (ED) requiring procedural sedation with ketamine.

Methods: This randomized, prospective clinical trial included patients aged 18-75 years who required procedural sedation with ketamine in the ED. Patients were randomized to receive IV ketamine at either 0.5 mg/kg (low dose) or 1 mg/kg (high dose). The primary outcome was the incidence of recovery agitation, assessed by the Richmond Agitation-Sedation Scale (RASS) at 5, 15, and 30 min following the procedure, in both dosage groups. Secondary outcomes included overall efficacy, sedation duration, and changes in vital signs.

Results: A total of 108 patients were enrolled in the study, 54 in each group. The median (IQR) RASS scores at 5, 15, and 30 min were -4 (-5 to -4), -1 (-1.3 to 0), and 0 (-1 to 0.5), respectively, in the low-dose group and -4 (-5 to -4), -1 (-3 to 0), and 0 (0 to 0), respectively, in the high-dose group. The incidence of recovery agitation was similar between the low- and high-dose groups (difference 1.9%, 95% confidence interval [CI] -14.8% to 18.4%). No significant difference was observed in sedation duration between the two groups (difference 0%, 95% CI -3.0% to 4.0%). While no additional ketamine was required in the high-dose group, four patients (7.4%) in the low-dose group required an additional half-dose (difference 7.4%, 95% CI -2.3% to 18.7%). Changes in vital signs were similar between the two groups.

Conclusions: There was no significant difference in recovery agitation, sedation duration, and changes in vital signs between 0.5 and 1 mg/kg IV ketamine for procedural sedation in the ED.