As has been widely reported in the media, during the summer of 2019, Elijah McClain was detained by police, and then emergency medical services (EMS) administered ketamine to Mr. McClain for excited delirium. Mr. McClain went into cardiac arrest during ambulance transport and died in the hospital a few days later. The coroner concluded that Mr. McClain died of undetermined causes. His death occurred the summer before the murder of George Floyd, but the circumstances of his death gained national attention during the Black Lives Matter demonstrations in the summer of 2020. These demonstrations protested the social injustices perpetrated against people of color and gained traction as the deaths of other young African American men that occurred during police interactions came under intense public scrutiny.
The review that culminated in this report was not undertaken to investigate Elijah McClain’s death or any particular case in which a Coloradan was administered ketamine by state-certified or state-licensed paramedics. Rather, the circumstances surrounding Elijah McClain’s death, and the resulting questions around the administration of ketamine for “excited delirium syndrome,” (ExDS) prompted the Colorado Department of Public Health and Environment (CDPHE) to undertake an investigatory review of its program that allows paramedics to administer ketamine.
One of CDPHE’s responsibilities is to certify or license individuals who provide medical care to patients in the emergent, prehospital environment and transport those patients to hospitals by ambulance. Upon certification or licensure (see EMS System Scope and Practice for discussion of distinction between certification and licensure), these individuals are referred to as EMS providers and they include four levels: three levels of Emergency Medical Technicians (EMTs), and Paramedics. Through rulemaking, the acts and medications that can be performed and administered by each level of EMS provider are authorized and are referred to as the EMS provider’s scope of practice. EMS providers are not independent practitioners; instead, in order to practice, they must be under the direction of a Colorado-licensed physician medical director. All EMS ambulance agencies are required to have a medical director who is responsible for ensuring the competency of the EMS providers for whom medical direction is provided. The Colorado Medical Board (CMB) in the state Department of Regulatory Agencies (DORA) regulates physicians, and CDPHE sets standards for physicians to be EMS medical directors. CDPHE does not regulate ground ambulance agencies.
Currently, the administration of ketamine, a dissociative anesthetic, is out of scope for all EMS providers except for paramedics who have obtained a Critical Care Endorsement (P-CC) from CDPHE. However, to accommodate recognized community needs, CDPHE is authorized to issue individual waivers to EMS agency medical directors who can successfully meet several criteria. These waivers expand the scope of practice of identified paramedics to include ketamine administration. It is through these waivers that paramedics are authorized to administer ketamine for various conditions, including excited delirium and/or extreme or profound agitation.
The overarching goals of the review were to evaluate the safety and efficacy of ketamine’s use in the prehospital setting by paramedics, and to determine whether CDPHE can improve its regulatory oversight of the ketamine waiver program. In order to have the necessary medical expertise for the review, CDPHE established a panel of external medical professionals, hereinafter referred to as the Ketamine Investigatory Review Panel (KIRP or panel). The panel’s review was facilitated by CDPHE’s Chief Medical Officer, Dr. Eric France.
The KIRP was charged with determining whether CDPHE’s existing waiver process for ketamine administration for excited delirium and/or extreme or profound agitation provides adequate oversight and training to ensure public health and safety. The panel focused on systems and processes rather than on individual cases of ketamine use, in keeping with CDPHE’s public health focus of protecting the health of people and their communities. The work of the panel was entirely separate from any regulatory investigations being conducted by CDPHE into complaints received about particular incidents. The panel did not review the use of ketamine for pain management or rapid sequence induction (RSI) in the prehospital setting.
Ketamine Investigatory Review Panel Scope of Work:
- the pharmacology of ketamine
- the diagnosis of Excited Delirium Syndrome (ExDS)
- the use of and indications for ketamine for ExDS and other medical conditions
- implicit and explicit bias and structural racism as it relates to indications for and administration of ketamine
- Colorado and national data on ketamine administration
- complications associated with ketamine use for ExDS
- the dosing of ketamine
- the monitoring of patients following ketamine administration
- the education and training for paramedics
- EMS medical director oversight, protocols, and quality assurance
- the state and local oversight processes
The COVID-19 pandemic necessitated online rather than in-person meetings. Beginning in early 2021, the panel convened numerous times via Zoom. The meetings were not open to the public to allow the panel members to speak freely and without fear of recrimination during the pendency of their work. The meetings were also closed to protect against an inadvertent identification of patients during data presentations.
The panel spent several months gathering and reviewing information, including articles, research studies, professional organizational documents and statements, videos and data. CDPHE enlisted a series of subject matter experts in other relevant areas to assist the panel in its work. A listing of the subject matter experts and the issues on which they presented is shown below:
- Dr. Whitney Barrett, board-certified EMS physician in Albuquerque, New Mexico; Assistant Medical Director for Denver Health Paramedics Division until January 2021. Dr. Barrett presented data on ketamine administration by the Denver Health Paramedic Division.
- Dr. William Hall, Emergency Medicine Telluride Regional Medical Center; Medical Director Nucla-Naturita Fire Protection District and the National Park Service; previous EMS medical director for Mesa County (9 agencies) for 17 years. Dr. Hall presented on the practice of EMS medical direction, including in rural settings.
- Dr. Brent Myers, triple-board certified in emergency medicine, EMS, and clinical informatics; past-President of the National Association of EMS Physicians; currently serves as the Chief Medical Officer for ESO; and Associate Medical Director for Wake EMS in Raleigh, North Carolina. Dr. Myers previewed data from the Annals of Emergency Medicine article: “Out-of-Hospital Ketamine: Indications for Use, Patient Outcomes, and Associated Mortality.”
- Dr. Scott Simpson, MPH, Medical Director for Psychiatric Services at Denver Health and Associate Director of Behavioral Health Services. Dr. Simpson presented on agitation management in psychiatric emergency services.
- Dr. Michele Sweeney, emergency medicine physician for 23 years; EMS Department Medical Director and faculty member, Pueblo Community College. Dr. Sweeney presented on paramedic education and challenges facing rural emergency medical services.
- Dr. Steven Zeichner, Anesthesiologist, President-Elect, Colorado Society of Anesthesiologists (CSA). Dr. Zeichner presented CSA’s concerns and recommendations related to CDPHE’s ketamine waiver program for excited delirium.