A Randomized, Non-Inferiority, Controlled Trial of Two Doses of Intravenous Sub-Dissociative Ketamine for Analgesia in the Emergency Department. Journal Article

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Authors: Lovett, S; Reed, T; Riggs, R; Lew, G; Koch, E; Durazo-Arvizu, RA; Rech, MA
Article Title: A Randomized, Non-Inferiority, Controlled Trial of Two Doses of Intravenous Sub-Dissociative Ketamine for Analgesia in the Emergency Department.
Abstract: OBJECTIVE: This study aimed to determine if 0.15 mg/kg of intravenous (IV) sub-dissociative ketamine is non-inferior to 0.3 mg/kg in emergency department (ED) patients with acute pain. METHODS: This randomized, prospective, double-blinded, non-inferiority trial included patients age 18-59 years presenting to the ED with acute moderate to severe pain. Subjects were randomized to IV sub-dissociative ketamine 0.15mg/kg ("low" dose) or 0.30 mg/kg ("high" dose) over 15 minutes. The primary endpoint was the 11-point numerical rating scale (NRS) pain score between groups at 30 minutes. Secondary endpoints included NRS pain scores at 15 and 60 minutes, change in NRS at 15, 30 and 60 minutes, rescue analgesia, and adverse effects. The non-inferiority limit, d , was set to 1.3. RESULTS: Forty-nine patients were included in each group. After adjusting for differences in the baseline NRS score, the mean NRS score at 30 minutes was 4.7 (95% confidence interval [CI] 3.8 - 5.5) in the low dose group and 5.0 (95% CI 4.2 - 5.8) in the high dose group (mean difference 0.4 [95% CI -0.8 - 1.5]), indicating that the low dose sub-dissociative ketamine was non-inferior to high dose (lower limit of 95% CI = -0.8 = - 1.3 = - d ). Adverse effects were similar at 30 minutes. At 15 minutes, the high dose group experienced greater change in NRS; however, more adverse effects occurred. CONCLUSION: Our data did not detect a large difference in analgesia or adverse effect profile between 0.15 mg/kg IV ketamine and 0.30 mg/kg in the short-term treatment of acute pain in the ED.
Journal Title: Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
Publisher: Unknown  
Date Published: 2020