Having determined that Excited Delirium Syndrome is not an appropriate medical condition for which ketamine should be administered, the panel extensively discussed whether it could identify verifiable medical conditions for which the administration of ketamine might be appropriate in the prehospital field.
The panel found it difficult to identify either a specific medical diagnosis or verifiable medical indications for which the use of ketamine in the prehospital setting is appropriate. Although isolated conditions may warrant the administration of ketamine, they are difficult to assess. For instance, in theory, extreme agitation may produce a hypermetabolic state that leads to acidosis, placing a patient at risk for cardiac arrest and sudden death. Metabolic acidosis cannot be accurately assessed in the prehospital setting, however. Thus, a patient in this state would likely require chemical restraint before s/he could be assessed, treated, and transported to the hospital to receive necessary medical therapy for the condition. The panel therefore pivoted from the difficult task of identifying verifiable medical indicators that might justify ketamine administration to a pragmatic inquiry of the situations EMS providers confront in the prehospital setting that might warrant the administration of ketamine.
The constant thread that ran through the panel’s discussions was the recognition that most prehospital setting patients who receive ketamine exhibit an excessive state of agitation. According to the Richmond Agitation Sedation Scale (RASS), agitation occurs along a continuum from an unarousable state to the highest level, which presents as a patient who is overtly combative, violent, and an immediate danger to staff. This level of agitation is commonly referred to as “excessive,” “extreme,” “severe,” or “profound,” and EMS providers occasionally encounter patients who display this state of agitation in the prehospital setting. However, the panel acknowledged that determination of a patient’s level of agitation is a subjective judgment call that is susceptible to abuse. Moreover, while excessive agitation can jeopardize a patient’s physical health, the panel members noted that patients rarely die from agitation. Therefore, the panel declined to recommend that agitation should be recognized as a singular medical or psychological condition that justifies the administration of ketamine in the prehospital setting.
Panel members re-oriented their investigation and grappled with the question of ketamine’s value in the prehospital setting. The major utility of ketamine in the prehospital setting, the panel found, is to manage the scene for the safety of the patient and others. The small subset of highly agitated persons who are at risk for cardiac arrest due to a hypermetabolic state would likely require chemical restraint for the purpose of safely managing the situation. Specifically diagnosing this hypermetabolic medical risk is therefore not of primary focus: in managing the agitation, the patient experiencing a hypermetabolic state would receive the sedative for restraint purposes which would also reduce the medical risk associated with this state.
The situation most commonly encountered by paramedics that results in ketamine administration involves a highly agitated person who, because of a behavioral health or medical issue that requires treatment, does not cooperate with paramedics. A person exhibiting such a high level of agitation is sometimes not responsive to verbal de-escalation. Under these circumstances, EMS providers cannot make a medical assessment or safely transport the patient to a hospital for evaluation and treatment.
The panel agreed that the benefits of permitting paramedics to administer ketamine (or any other sedative medication) to such a patient for the purpose of safely transporting him/her in a safe and effective manner for evaluation and medical treatment outweighs the risk associated with this medical therapy. The panel acknowledged that while paramedics can administer other drugs to intervene on behalf of the patient’s safety in the prehospital setting, providers favor the use of ketamine because of its rapid onset and moderate duration (see dosing discussion below). The panel therefore reached consensus that the use of ketamine in the prehospital setting is appropriate when: 1) the paramedic has made a professional judgment that the patient requires immediate evaluation, 2) the patient has not responded to verbal de-escalation or any less restrictive alternative (such as physical restraint), and 3) the patient’s conduct/agitation prevents the paramedic from providing safe treatment and transport to the hospital for necessary medical care.
Once this framework was established, the panel realized that its focus on safely mitigating the risk of physical harm to the patient aligned in most respects with existing Colorado law that governs the use of chemical, physical, and mechanical restraints.[34]
For purposes of its review, the panel learned that the chemical restraint law can be employed to restrain a patient in the prehospital setting if:
- the patient poses a serious, probable, imminent threat of bodily harm to self or others; and
- the patient has the present ability to carry out that threat of bodily harm to self or others; and
- the paramedic has
- tried to use less restrictive alternatives that failed; or
- determined that less restrictive alternatives would be ineffective or inappropriate under the circumstances; and
- the paramedic has engaged in a telephone consultation with a physician about the emergency and the physician has issued an order to administer the chemical restraint as the least restrictive, most appropriate alternative available.[35]
The chemical restraint law utilizes “threat to self or others” as the standard governing the lawful administration of a chemical restraint to a person involuntarily. The sole embedded medical component requires that a physician must order the chemical restraint if the “threat to self or others” standard is satisfied. The panel concurred that, except for the contemporaneous physician order requirement, the law reflects its essential conclusion concerning the administration of ketamine in the prehospital setting: namely, that it should only be administered to patients when a risk of physical harm exists, where safe transport and treatment is required, and when less restrictive alternatives won’t work. In fact, the panel reached consensus that the use of ketamine in the prehospital setting does rise to the level of restraint in these situations and recommends that the term “restraint” should be used instead of “sedation.”
The panel’s recommendation is qualified in two critical respects. First, after extensive discussion, the panel recommends that the chemical restraint law be amended to allow paramedics to administer ketamine under the authority of a physician’s standing written order. This recommended modification is critical because paramedics typically do not have the ability to consult with a physician to receive the contemporaneous order. Some rural paramedics respond to patients in locations that do not have viable cell phone service, preventing them from satisfying the requirement. And in all regions, paramedics will frequently respond to a chaotic situation where time is of the essence. In this scenario, patients who do not respond to verbal de-escalation must be restrained quickly, before they can inflict harm to self or others. Panel members noted that paramedics can likely encounter delays of several minutes or more before a physician is available to take the call, and that delay puts the patient at risk. Consequently, the panel recommends that the General Assembly amend the chemical restraint law to delete the contemporaneous telephone consultation requirement as it applies to paramedics in the prehospital setting.[36] Instead, the law should require paramedics to maintain adherence to a standing written order protocol when administering ketamine in the prehospital setting. This recommendation comports with the AMA’s Ethical Opinion 1.2.7, “Use of Restraints,” which provides, “[e]xcept in emergencies, patients should be restrained only on a physician’s explicit order.” [28(p. 2)] (emphasis supplied)
Second, the panel recognizes that, as with most standards, the “threat of bodily harm to self or others” guideline can be subject to abuse. The panel did not need to look farther than the Elijah McClain case to understand how the ever-present threat of a biased judgment may result in an improper ketamine administration with tragic consequences. To address and ameliorate the potential for this kind of abuse and bias, the panel recommends two things:
- CDPHE should require EMS agencies whose medical directors have waivers for the administration of ketamine as a chemical restraint to train EMS providers on the “serious, probable, imminent threat of bodily harm to self or others” standard as enunciated in the chemical restraint law. Training should focus on the paramedic’s duty to make an independent professional judgment concerning the patient’s threat of harm to self or others, and the ability to execute that threat, after verbal de-escalation efforts have failed. Paramedics will encounter patients who meet this standard by placing themselves in harm's way (i.e., running into the street or threatening the use of a weapon against self). Alternatively, they will encounter patients who exhibit symptoms indicating an underlying medical condition that requires safe transport and treatment at the hospital (without which, the patient will suffer a serious, probable, and imminent threat of harm).
- Paramedics are presumed to act in the best medical interests of the patient. Nevertheless, bias impacts health care delivery in general and, as discussed above, has specifically infiltrated the ExDS assessment with the result that ketamine is sometimes deployed unnecessarily and disproportionately. Therefore, the panel proposes that paramedics should affirmatively adhere to this principle before administering ketamine in the prehospital setting.
In other words, once the paramedic makes an independent professional judgment that the patient presents a serious, probable, and imminent threat of physical harm to self or others with the ability to carry out the threatened harm, the paramedic should next be required to determine that the deployment of ketamine is “in the patient’s best medical interest.” Application of this additional standard will require the paramedic to identify a medically sound reason for deploying ketamine in an emergency setting to a patient who poses a risk of harm to self or others. This will, in practice, comport with the following professional standards:
- AMA’s Ethical Opinion 1.2.7, “Use of Restraints,” recognizes that “Physicians who order chemical or physical restraints should: . . . use best professional judgment to determine whether restraint is clinically indicated for the individual patient.”[28 (p. 2)] No less should be expected of paramedics who operate in the prehospital setting under a physician’s license.
- Moreover, application of the “best medical interests” standard is necessary to align with the National Association of EMS Physicians (NAEMSP) statement that requires EMS providers in emergency patient restraint situations “to identify and manage clinical conditions that may be contributing to a patient’s combative or violent behavior,” including, but not limited to, hypoxia, hypoglycemia, alcohol or drug intoxication, stroke, and brain trauma.[37]
Requiring the paramedic to affirmatively consider the patient’s best medical interests as part of the chemical restraint calculus should operate to check and deter bias, and may ultimately protect patients from receiving unnecessary and involuntary ketamine administrations.
PANEL RECOMMENDATION
CDPHE should issue waivers that allow paramedics to administer ketamine to patients whose serious, probable, and imminent threat of harm to self or others prevents EMS providers from safely assessing, treating, and transporting the patient to a hospital.