A randomized, noninferiority, controlled trial of two doses of intravenous subdissociative ketamine for analgesia in the emergency department

Objective This study aimed to determine if 0.15 mg/kg intravenous (IV) subdissociative ketamine is noninferior 0.3 in emergency department (ED) patients with acute pain. Methods randomized, prospective, double-blinded, noninferiority trial included patients’ age 18 59 years presenting the ED moderate severe Subjects were randomized IV ketamine, ("low" dose) or 0.30 ("high" dose), over 15 minutes. The primary endpoint was 11-point numeric rating scale (NRS) pain score between groups at 30 Secondary endpoints NRS scores and 60 minutes; change 15, 30, rescue analgesia; adverse effects. limit, δ0, set 1.3. Results Forty-nine each group. After differences baseline adjusted for, mean minutes 4.7 (95% confidence interval [CI] = 3.8 5.5) low-dose group 5.0 CI 4.2 5.8) high-dose (mean difference 0.4, 95% −0.8 1.5), indicating that high dose (lower limit of –0.8 ≥1.3 –δ0). Adverse effects similar At minutes, experienced greater NRS; however, more occurred. Conclusion Our data did not detect a large analgesia effect profile short-term treatment ED.