Rapid Agitation Control With Ketamine in the Emergency Department: A Blinded, Randomized Controlled Trial - 18/11/21
, Gary Andolfatto, MD a, Brian Grunau, MD, MSCH a, c, Frank X. Scheuermeyer, MD, MHSc a, c, Bill Macewan, MD b, Hong Qian, MSc c, Hubert Wong, PhD c, Skye P. Barbic, PhD c, d, William G. Honer, MD bAbstract |
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.
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| Please see page 789 for the Editor’s Capsule Summary of this article. |
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| Supervising editor: Steven M. Green, MD. Specific detailed information about possible conflict of interest for individual editors is available at editors. |
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| Author contributions: DB, GA, BG, FXS, BM, SPB, and WGH conceived and designed the study. DB obtained funding and regulatory approval. DB, BG, and FXS were involved with the daily conduct of the study. DB, HQ, and HW conducted the statistical analysis. All authors were involved in the drafting and revision of this manuscript. DB takes responsibility for the paper as a whole. |
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| All authors attest to meeting the four ICMJE.org authorship criteria:(1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. |
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| Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (seewww.icmje.org). The authors have stated that no such relationships exist. This study was supported by peer-reviewed funding from the Vancouver Coastal Health and Providence Health Care Research Institutes and the Canadian Association of Emergency Physicians. The funders had no role in the conduct, analysis, or interpretation of the trial results. All authors had full access to all of the data in the study and take responsibility for the integrity of the data and accuracy of the data analysis. |
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| Trial registration number: NCT03375671 |
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| This study will be presented at the Society for Academic Emergency Medicine (SAEM) 2021 annual conference (May 13, 2021; Atlanta, GA), and the Canadian Association of Emergency Physicians (CAEP) 2021 annual conference (June 16, 2021; Winnipeg, MB). |
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Vol 78 - N° 6
P. 788-795 - décembre 2021 Retour au numéro
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