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KIRP Report Endnotes

  1. A medication that causes altered sensory perceptions and a feeling of disconnect between the environment and self. 
  2. In July 2021, after the panel had commenced its review, CDPHE suspended the ketamine waiver program for excited delirium and/or extreme or profound agitation due to HB 21-1251’s enactment into law. (See Section II.B.)  
  3. NHTSA's Office of EMS's mission is to reduce death and disability by providing leadership and coordination to the EMS community in assessing, planning, developing, and promoting comprehensive, evidence-based emergency medical services and 911 systems.
  4. Section 25-3.5-302, C.R.S.
  5. Section 25-3.5-202, C.R.S.
  6. Section 25-3.5-203(1)(b.5), C.R.S.
  7. See Section 25-3.5-206(4)(a)(I), C.R.S.
  8. See 6 CCR 1015-3, Chapter Two, pages 43-56, as accessed through “rules” link in text, above.  
  9. Section 25-3.5-203(1)(a.5), C.R.S. 
  10. See Section 25-3.5-206(4)(a)(II) and (IV), C.R.S.
  11. A type 1 board exercises its prescribed statutory powers, duties, and functions independently of the head of the executive department in which they are housed. For example, the Colorado Medical Board is in the Department of Regulatory Agencies (DORA) but functions independently of DORA. A type 2 board, in contrast, is not independent of the department in which it sits and has no formal authority to act, only to advise and recommend. See Sections 24-1-105(1) and (2), C.R.S.
  12. See Section 25-3.5-206(4)(a)(III), C.R.S.
  13. The terms excessive, extreme, or profound agitation are used interchangeably with excited delirium regarding this waivered medication and indications for use.   
  14. CDPHE did not suspend existing ketamine waivers for pain management and rapid sequence induction (RSI). 
  15. Sections 25-3.5-307.5(1)(h), 25-3.5-308(1)(e), and 25-3.5-501, C.R.S.
  16. 6 CCR 1015, Chapter Three, Section 3.3.1; see also Sections 25-3.5-501 & 704(2)(h), C.R.S.
  17. Appendix F includes a description of the 40 data elements.
  18. The panel remarked on the absence of race/ethnicity and zip code data, which makes presenting ketamine use by race/ethnicity in Colorado unachievable.
  19. Examples of “Other” complications include: decrease in GCS, hypersalivation, patient became unresponsive, vomiting, and inadequate sedation.
  20. Later review of the data submitted to EMPAC established that two of the records were duplicated. Therefore, while the chart in the EMPAC presentation (Appendix E) shows that there were 75 hypoxia complications, there were, in fact, only 73 hypoxia complications.  
  21. Colorado law allows CDPHE to access prehospital patient records for statewide continuing quality improvement (CQI) efforts. All information provided, as well as records or reports compiled as a result of the CQI system, are confidential and exempt from public disclosure under the Colorado Open Records Act. Section 25-3.5-704(2)(h)(I), (II), C.R.S. This statutory provision applies to the records and reports utilized for the quality improvement review of the data on complications. 
  22. Fernandez AR, Bourn SS, Crowe RP, et al.  Out-of-hospital ketamine:  Indications for use, patient outcomes, and associated mortality. Ann Emerg Med. 2021; 78(1):123-131.
  23. CDPHE staff provided information establishing that, in 2019, the median first dose of ketamine was 4.6 mg/kg.  In 2019, 2 patients who received ketamine in the prehospital field received 3 doses of ketamine, while 35 patients received 2 doses of ketamine. Therefore, of the 454 patients who received ketamine in 2019, the 37 patients who received multiple doses represents 8% of all patients who received ketamine in the prehospital field in 2019.
  24. The rate in Colorado may be an overrepresentation because of inconsistent reporting criteria.
  25. American College of Emergency Physicians, ACEP Excited Delirium Task Force: White Paper Report on Excited Delirium Syndrome.  Dated September 10, 2009.
  26. According to the National Model EMS Clinical Guidelines, excited delirium/exhaustive mania is defined as “[a] postmortem diagnosis of exclusion for sudden death thought to result from metabolic acidosis (most likely from lactate) stemming from physical agitation or physical control measures and potentially exacerbated by stimulant drugs (e.g. cocaine) or alcohol withdrawal.”
  27. American College of Emergency Physicians, ACEP Task Force Report on Hyperactive Delirium with Severe Agitation in Emergency Settings. Dated June 23, 2021.  See https://www.acep.org/globalassets/new-pdfs/education/acep-task-force-report-on-hyperactive-delirium-draft-.pdf
  28. American Medical Association, The Council On Science And Public Health Reference Committee E Report 2: Use of Drugs to Chemically Restrain Agitated Individuals Outside of Hospital Settings-June 2021. https://www.ama-assn.org/system/files/2021-05/j21-csaph02.pdf.
  29. Sekhon S, Fischer M, Marwaha R. Excited Delirium. [Updated 2021 Jul 19]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK546674 
  30. The AMA has relied on independent studies to conclude that most deaths attributable to ExDS occur during or after the individual was placed in police custody that involved some form of physical restraint.  “Reports estimate that ExD is in question in more than 3 percent of police interventions that use force and more than 10 percent of the deaths that occur within law enforcement custody are associated with ExD. Reports also note that between 38 and 86 percent of all fatal ExD cases occur in police custody and that law enforcement officers encounter one person with ExD in every 58 use of force incidents.”  AMA Rep., p, 4.  Also, “results have indicated that a diagnosis of ExD and potentially fatal restraint are “inextricably interwoven.” . . . Authors note that there is no evidence to support ExD as a cause of death in the absence of restraint.”  AMA Rep., p. 6.
  31. An “academic poster” is a way of concisely portraying research to an audience using graphics and/or pictures and a relatively small amount of text (somewhere between 300-500 words). They are widely used at conferences. 
  32. Miller M, Watanabe B, Brown L. Are there gender or racial disparities in EMS-administered sedation among patients in police custody [abstract taken from Prehospital Emergency Care. 2021; 25(1):125-170]. 
  33. Budhu J, O’Hare M, Saadi, A. How “excited delirium” is misused to justify police brutality. Brookings Inst. How We Rise blog. Posted August 10, 2020. Accessed July 20, 2021.  https://www.brookings.edu/blog/how-we-rise/2020/08/10/how-excited-delirium-is-misused-to-justify-police-brutality/.
  34. See Section 26-20-101 et seq., C.R.S. 
  35. The law forbids chemical restraint from being used as punishment or retaliation. See Section 26-20-103(1.5), C.R.S.  If medication is administered for life-saving purposes, the law does not require adherence to the above requirements.  See Section 26-20-102(2), C.R.S.
  36. Until or unless the General Assembly amends the chemical restraint law, paramedics must continue to comply with the existing legal requirement that they consult with and receive a physician’s verbal order to administer a chemical restraint before doing so.   
  37. The AMA also recognizes that circumstances exist in which “health conditions may result in behavior that puts patients at risk of harming themselves. . . . In certain limited situations, when a patient poses a significant danger to self or others, it may be appropriate to restrain the patient involuntarily. In such situations, the least restrictive restraint reasonable should be implemented and the restraint should be removed promptly when no longer needed.”  See FN 28, p. 2.  
  38. Neuroleptic malignant syndrome is a rare, life-threatening reaction seen with antipsychotics (i.e., haloperidol).  Its symptoms and findings include extreme fever, arrhythmias, metabolic derangements, muscle injury, altered mental status, and blood pressure instability (among other findings).
  39. See https://www.google.com/url?q=https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/016812Orig1s046lbl.pdf&sa=D&source=editors&ust=1627410673576000&usg=AOvVaw2PbtkWQ9yHZxm40Y3Z9pjg. 
  40. The amount of drug that results in death in 50% of experimental animals tested.
  41. Orhurhu VJ, Vashisht R, Claus LE, Cohen SP. Ketamine Toxicity. [Updated 2021 Jul 25]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK541087/  .
  42. Arnbjerg J. Clinical manifestations of overdose of ketamine-xylazine in the cat. Nord Vet Med (1979); 31(4):155-161. 
  43. See Helmer J, Acker J, Deakin J, Johnston T. Canadian paramedic experience with intramuscular ketamine for extreme agitation: A quality improvement initiative. Australasian Journal of Paramedicine 2020;17: 1-9. https://ajp.paramedics.org/index.php/ajp/article/view/763/962 and https://doi.org/10.33151/ajp.17.763 
  44. See Cole, JB, et al., “A prospective study of ketamine as primary therapy for prehospital profound agitation”; American Journal of Emergency Medicine (May 2018); 36:789-796. PMID: 29033344  DOI: 10.1016/j.ajem.2017.10.022; 
  45.  https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016812s040lbl.pdf
  46. Green SM, Clark R, Hostetler MA, Cohen M, Carlson D, Rothrock SG. Inadvertent ketamine overdose in children: clinical manifestations and outcome. Ann Emerg Med. 1999; 34(4 Pt 1): 492-497.
  47. Burnett AM, Peterson BK, Stellpflug SJ et al. The association between ketamine given for prehospital chemical restraint with intubation and hospital admission.  Am J Emerg Med. 2015;33(1):76-79.  
  48. Parks DJ, Alter SM, Shil RD, Solano JJ , Hughes PG, Clayton LM.  Rescue Intubation in the Emergency Department After Prehospital Ketamine Administration for Agitation. Prehosp Disaster Med. 35(6):651-655 (Dec. 2020).
  49. Cole JB, Moore JC, Nystrom PC et al. A prospective study of ketamine versus haloperidol for severe prehospital agitation. Clin Toxicol 2016; 54(7): 556-562.
  50. Green SG, Roback MG, Kennedy RM, Krauss, B. Clinical practice guideline for emergency department ketamine dissociative sedation: 2011 update. Ann Emerg Med. 2011;57(5):449-461. 
  51. Stoelting R, Creasser C, Martz R. Effect of cocaine administration on halothane MAC in dogs. Anesth Analg 1975; 54:422-4. 
  52. Bernards C, Teijeiro A. Illicit cocaine ingestion during anesthesia.  Anesthesiology 1995; 84:218-20.
  53. McVaney K. Ketamine: Review and shared expertise. Lecture presented at: NAEMSP Education Webinar, Prehospital Ketamine Use for the Combative Patient; November 6, 2020, Denver, CO. https://kellen.zoom.us/rec/play/ZoYaPqkmoPj5lM0QZ3yHEpR0XfPhoLt6nS6eugQBFPv_YtU-cBz7PGzaoWueMNj3MCMMmMKs1qkKacdq.GJ_tZU30HexLmDA- 
  54. Boehm K, Welt C, Grimaldi J. Accuracy of patient height, weight and ideal body weight estimates in the emergency department. Spartan Med Res J. 2017;1(2). doi:10.51894/001c.5934 (weight estimations based on photographs of patients)
  55. The panel discussed the merits of equipping ambulances with portable monitoring equipment (“Propaqs”) to take patient-side. These compact monitors are used in hospitals to track patient vital signs such as temperature, pulse, blood pressure, and end tidal CO2, while they are transported from one clinical setting site to another, i.e., from the Emergency Room to the Intensive Care Unit.  Other states such as Texas require some ambulances to be equipped with these portable monitors, but Colorado regulations do not mandate this equipment. The panel encourages Colorado ground ambulance agencies to equip licensed ambulances with these portable monitoring devices but acknowledges they might be cost-prohibitive.  
  56. Since the order in which the monitoring occurs is important, the panel recommends that each ambulance must have a  “cheat sheet” on board that includes this ketamine monitoring protocol and is immediately available for the paramedic’s reference. (See Recommendation C.4)
  57. Burness A. Underfunded, overworked and urgently needed: The state of EMS in rural Colorado. The Denver Post. July 23, 2021. Accessed July 23, 2021. https://www.denverpost.com/2021/07/23/rural-ems-crisis-funding-shortfall-colorado/ 
  58. Colorado: County Designations, 2021. State Office of Rural Health. Site addresses were collected and geocoded by the State Office of Rural Health, current as of January, 2016. https://coruralhealth.org/resources/maps-resource 
  59. Section 25-3.5-308 (1)(c), C.R.S.
  60. Section 25-3.5-206(4), C.R.S.
  61. Section 12-240-121(1)(j), C.R.S. 
  62. NAEMSP is a national organization whose members are the state medical directors from the state government agency that regulates EMS in the state. Eagles Coalition is a national organization composed of 60-70 EMS medical directors from large 911 agencies across the country. 
  63. See, e.g., National Model EMS Clinical Guidelines: Agitated or Violent Patient/Behavioral Emergency at p. 53-54 (January 2019). 
  64. Remediation methods mentioned include the provision of feedback, formal discipline, retraining, or removal from the waiver program. 
  65. The National Association of EMS Physicians. Patient Restraint in Emergency Medical Services Restraint position statement Approved Version for PEC  Published 2016. Accessed June 18, 2021.
  66. Section 25-3.5-206(3)(a), C.R.S.
  67. Colorado is one of 49 states that regulates air ambulances at the state level. (See Appendix J).
  68. Section 25-3.5-301(1), C.R.S.
  69. Some counties enter into memorandums of understanding or reciprocal licensing arrangements with other counties so that a ground ambulance agency has to apply only once for a license to service an area that crosses multiple counties. This is the case in the Denver Metro area.
  70. Section 25-3.5-308(1) (a) - (e), C.R.S.
  71. U.S. Department of Transportation, National Highway Traffic Safety Administration, EMS Agenda 2050 Technical Expert Panel: EMS Agenda 2050: A People-Centered Vision for the Future of Emergency Medical Services, (Report No. DOT HS 812 664) at p. 19. Published January, 2019.
  72. Section 24-4-101 et seq., C.R.S.
  73. 6 CCR 1015-3, Chapter3, Section 3.3.1; see also Sections 25-3.5-501 & 704(2)(h), C.R.S.
  74. 6 CCR 1015-3, Chapter 2, Section 12.6.1.
  75. Section 25-3.5-704(2)(h), C.R.S.
  76. Section 25-3.5-704(2)(h)(I)(E), C.R.S.
  77. Section 25-3.5-704(2)(h)(II), C.R.S.
  78. Section 24-4-103.3, C.R.S.