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

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.