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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)...

Extract

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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Copyright

Corresponding author

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

Footnotes

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Conflicts of interest: none

Footnotes

References

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1.Stratton, SJ. The Hennepin Ketamine Study. Prehosp Disaster Med. 2018;33(5):457458.
2.Le Cong, M. PHARM Podcast 208 Ketamine controversy with Minneapolis Police. PHARM: Prehospital and Retrieval Medicine. https://player.fm/series/prehospital-and-retrieval-medicine-podcast/pharm-podcast-208-ketamine-controversy-with-minneapolis-police. Published July 31, 2018. Accessed December 5, 2018.
3.Klein, L, Moore, J, Biros, M. A 20-year review: the use of Exception from Informed Consent and Waiver of Informed Consent in emergency research. Acad Emerg Med. 2018;25(10):11691177.
4.Miner, JR, Klein, LR, Cole, JB, Driver, BE, Moore, JC, Ho, JD. The characteristics and prevalence of agitation in an urban county emergency department. Ann Emerg Med. 2018;72(4):361370.
5.US Department of Health and Human Services, Food and Drug Administration. Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM603873.pdf. Accessed December 22, 2018.
6.Minnesota Statutes 2018. Vol 144E.265 Subd 2. https://www.revisor.mn.gov/statutes/cite/144E.265. Accessed December 22, 2018.
7.Martel, M, Miner, J, Fringer, R, et al. Discontinuation of droperidol for the control of acutely agitated out-of-hospital patients. Prehosp Emerg Care. 2005;9(1):4448.
8.Cole, JB, Moore, JC, Nystrom, PC, et al. A prospective study of ketamine versus haloperidol for severe prehospital agitation. Clin Toxicol . 2016;54(7):556562.
9.Miner, JR, Heegaard, W, Plummer, D. End-tidal carbon dioxide monitoring during procedural sedation. Acad Emerg Med. 2002;9(4):275280.
10.Malta Hansen, C, Kragholm, K, Dupre, ME, et al. Association of bystander and first-responder efforts and outcomes according to sex: results from the North Carolina HeartRescue Statewide Quality Improvement Initiative. J Am Heart Assoc. 2018;7(18):e009873.
11.Self, WH, Semler, MW, Wanderer, JP, et al. Balanced crystalloids versus saline in noncritically ill adults. N Engl J Med. 2018;378(9):819828.
12.McCormack, RP, Gallagher, T, Goldfrank, LR, Caplan, AL. Including frequent emergency department users with severe alcohol use disorders in research: assessing capacity. Ann Emerg Med. 2015;65(2):172177.e1.
13.Martel, ML, Klein, LR, Miner, JR, et al. A brief assessment of capacity to consent instrument in acutely intoxicated emergency department patients. Am J Emerg Med. 2018;36(1):1823.
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.
15.Dickert, NW, Sugarman, J. Ethics and regulatory barriers to research in emergency settings. Ann Emerg Med. 2018;72(4):386388.
16.Eucker, SA, Barrett, TW, Schriger, DL. Are two drugs better than one for acute agitation? A discussion on black box warnings, waiver of informed consent, and the ethics of enrolling impaired subjects in clinical trials. Ann Emerg Med. 2013;61(1):8283.
17.Kaji, AH, Schriger, D, Green, S. Looking through the retrospectoscope: reducing bias in emergency medicine chart review studies. Ann Emerg Med. 2014;64(3):292298.
18.Lowenstein, SR. Medical record reviews in emergency medicine: the blessing and the curse. Ann Emerg Med. 2005;45(4):452455.
19.Mankowitz, SL, Regenberg, P, Kaldan, J, Cole, JB. Ketamine for rapid sedation of agitated patients in the prehospital and emergency department settings: a systematic review and proportional meta-analysis. J Emerg Med. 2018;55(5):670681.
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.
23.Hick, JL, Smith, SW, Lynch, MT. Metabolic acidosis in restraint-associated cardiac arrest: a case series. Acad Emerg Med. 1999;6(3):239243.
24.IRB Waiver or Alteration of Informed Consent for Clinical Investigations. https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM566948.pdf. 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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Prehospital and Disaster Medicine
  • ISSN: 1049-023X
  • EISSN: 1945-1938
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