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The Hennepin Ketamine Study Investigators’ Reply

  • Jeffrey D. Ho (a1) (a2), Jon B. Cole (a1), Lauren R. Klein (a1), Travis D. Olives (a1), Brian E. Driver (a1), Johanna C. Moore (a1), Paul C. Nystrom (a1) (a2), Annie M. Arens (a1), Nicholas S. Simpson (a1) (a2), John L. Hick (a1) (a2), Ross A. Chavez (a2), Wendy L. Lynch (a2) and James R. Miner (a1)...


We read with interest the recent editorial, “The Hennepin Ketamine Study,” by Dr. Samuel Stratton commenting on the research ethics, methodology, and the current public controversy surrounding this study.1 As researchers and investigators of this study, we strongly agree that prospective clinical research in the prehospital environment is necessary to advance the science of Emergency Medical Services (EMS) and emergency medicine. We also agree that accomplishing this is challenging as the prehospital environment often encounters patient populations who cannot provide meaningful informed consent due to their emergent conditions. To ensure that fellow emergency medicine researchers understand the facts of our work so they may plan future studies, and to address some of the questions and concerns in Dr. Stratton’s editorial, the lay press, and in social media,2 we would like to call attention to some inaccuracies in Dr. Stratton’s editorial, and to the lay media stories on which it appears to be based.

Ho JD, Cole JB, Klein LR, Olives TD, Driver BE, Moore JC, Nystrom PC, Arens AM, Simpson NS, Hick JL, Chavez RA, Lynch WL, Miner JR. The Hennepin Ketamine Study investigators’ reply. Prehosp Disaster Med. 2019;34(2):111–113

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Corresponding author

Correspondence: Jeffrey D. Ho, Hennepin Healthcare System, Department of Emergency Medicine, Minneapolis, Minnesota USA E-mail:


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Conflicts of interest: none



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2.Le Cong, M. PHARM Podcast 208 Ketamine controversy with Minneapolis Police. PHARM: Prehospital and Retrieval Medicine. Published July 31, 2018. Accessed December 5, 2018.
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14.Cole, JB, Klein, LR, Mullinax, S, Nordstrom, KD, Driver, BE, Wilson, MP. Study enrollment when “pre-consent” is utilized for a randomized trial of two treatments for acute agitation in the emergency department. Acad Emerg Med. 2018. E-pub ahead of print.
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20.Buckland, DM, Crowe, RP, Cash, RE, et al. Ketamine in the prehospital environment: a national survey of paramedics in the United States. Prehosp Disaster Med. 2018;33(1):2328.
21.Martel, M, Sterzinger, A, Miner, J, Clinton, J, Biros, M. Management of acute undifferentiated agitation in the emergency department: a randomized double-blind trial of droperidol, ziprasidone, and midazolam. Acad Emerg Med. 2005;12(12):11671172.
22.Klein, LR, Driver, BE, Miner, JR, et al. Intramuscular Midazolam, Olanzapine, Ziprasidone, or Haloperidol for treating acute agitation in the emergency department. Ann Emerg Med. 2018;72(4):374385.
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24.IRB Waiver or Alteration of Informed Consent for Clinical Investigations. Accessed December 5, 2018.
25.Isenberg, DL, Jacobs, D. Prehospital Agitation and Sedation Trial (PhAST): a randomized control trial of intramuscular haloperidol versus intramuscular midazolam for the sedation of the agitated or violent patient in the prehospital environment. Prehosp Disaster Med. 2015;30(5):491495.
26.Cole, JB, Ho, JD, Biros, MH. Randomizing patients without consent: waiver vs exception from informed consent. Prehosp Disaster Med. 2016;31(4):457458.



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