Journal of Hospice and Palliative Nursing

Palliative Sedation in End-of-Life Care

Susan D. Bruce, RN, BSN, OCN, Cristina C. Hendrix, DNS, APRN-BC, GNP, FNP, Jennifer H. Gentry, RN, MSN, ANP, APRN-BC, PCM

Disclosures

Journal of Hospice and Palliative Nursing. 2006;8(6):320-327. 

The goals for care at the end of life include relief of pain and suffering. Despite excellent palliative care, some patients continue to experience intolerable, unrelieved pain and suffering from refractory symptoms. Palliative sedation, although controversial, is an accepted option for relieving pain and suffering at the end of life and can spark a great deal of emotion and debate for all involved. Hospice and palliative care nurses play a critical role in symptom management at the end of life and need to have a basic understanding of the principles of palliative sedation. Nurses must continue to advocate for their patients and provide education to other members of the healthcare team who are less knowledgeable about palliative sedation. This article explores these principles and some of the challenges associated with providing palliative sedation.

Adequate control of symptoms should be the standard of care for dying patients. An important goal to reach is the relief of pain and suffering;^[1] however, some patients develop intolerable pain and suffering despite excellent palliative care. In such patients, sedation has been used to treat pain, dyspnea, nausea and vomiting, delirium, and myoclonus in order to allow patients to die comfortably.^[2] When given with the sole intent of relieving pain and suffering at the end of life, sedation has become an accepted but highly controversial aspect of palliative care. The healthcare team and the family of the dying patient may face many moral, ethical, and legally challenging decisions throughout the dying process, which can elicit a great deal of emotion and debate. This article provides discussion about palliative sedation and its use in end-of-life (EOL) care. The ethical, legal, and moral issues that challenge healthcare professionals in using this modality of supportive care are highlighted. The article concludes with a discussion on the process of palliative sedation and nurses' roles.

 

Shaiova^[11] defined two therapeutic indications for palliative sedation and outlined the categories of the time course and depth of sedation. The indications for palliative sedation are relief of intractable pain when specific pain-relieving protocols or interventions are ineffective and relief of intractable emotional or spiritual anguish. Palliative sedation is an intervention that can be titrated to achieve desired clinical outcomes. The depth and intensity both can be titrated based on the needs of the patient. Shaiova categorizes palliative sedation as partial, total, temporary, and permanent. Partial sedation is titrated sedation against patient responsiveness with a patient-directed end point. Total sedation is titrated sedation against (apparent) complete unresponsiveness of patients (unconsciousness). The intent of temporary sedation is to provide a reversible deep sedation, as opposed to permanent sedation, in which the intent is to provide deep sedation until death occurs and without concern for reversibility.
The work of Morita et al^[12] proposes a combination of five subcategories of palliative sedation therapy as a way of handling the inconsistencies in definitions and describing the degree and duration of sedation. Duration of sedation is either continuous or intermittent. Continuous sedation is sedation in which a reduced level of consciousness is maintained without specifying plans to discontinue. This form of sedation continues to alter the patient's level of consciousness until he or she dies. On the other hand, intermittent sedation reduces the patient's consciousness for prolonged periods but also provides periods when the patient is alert by discontinuing or reducing sedative medications. Respite sedation, in which the patient is rendered unconscious for a period of time to bring about management of refractory symptoms, is an example of intermittent sedation. Degree of sedation is classified as mild or deep. Mild sedation is sedation to the degree that consciousness is maintained so that a patient can verbally or nonverbally communicate with caregivers. Deep sedation causes near or complete unconsciousness so that a patient is rendered unable to communicate with caregivers. Morita et al^[12] added a category that addresses the pharmacological properties of the medications used to induce palliative sedation. Sedation can be primary or secondary. Primary sedation is achieved by sedative medications that have not been proved to be pharmacologically effective to relieve underlying distress. Secondary sedation allows reduced unconsciousness accompanied with pharmacologically effective sedations for the relief of underlying symptoms. Based on these definitions, sedation can be described as primary-continuous-deep sedation for physical or psychological distress in patients with vital organ failure.^[6] Opioid dose escalation for severe pain that induces somnolence can be expressed as secondary-mild sedation for patients in pain without vital organ failure, including intermittent-continuous subtypes of sedation.^[13]

In addition to the principles of beneficence, maleficence, justice, autonomy, and futile care, two ethical principles that play a lead role in guiding the clinical practice of palliative sedation are the doctrine of double effect and the principle of proportionality. At the heart of the ethical debate over palliative sedation is the differentiation between sedation for intractable symptoms and euthanasia. The distinction lies in the intent. The intent of palliative sedation is relief of intractable distress, whereas the intent of euthanasia is to end life. The ethical justification for palliative sedation is the doctrine of double effect.

The doctrine of double effect has its roots in Roman Catholic theology.^[14] It is used when it is impossible to avoid harmful effects. It helps us choose between two actions when neither choice is what we would want. The doctrine of double effect makes the distinction between an intended effect and an unintended effect of an intervention. The doctrine of double effect holds that intentionally causing death is not acceptable but prescribing high doses of sedatives and opioids to relieve pain is, even if the resulting death is foreseen. The doctrine has four conditions according to Sulmasy and Pellegrino:^[15]

An action with two possible effects, one good and one bad, is morally permitted if the action (1) is not in itself immoral, (2) is undertaken only with the intention of achieving the possible good effect, without intending the possible bad effect, although it may be foreseen, (3) does not bring about the possible good effect by means of the possible bad effect, and (4) is undertaken for a proportionately grave reason.

In palliative sedation, the act itself must be good or at least neutral (administering pain medications or sedation); the intention of the act is to produce a good effect (relief of pain or suffering), although a harmful effect (death) is foreseeable in some cases; the harmful effect of the act must not be the means to the good effect (death is not the means to relieve suffering); and the good effect must outweigh or balance the harmful effect (principle of proportionality). The principle of proportionality is established by the terminal condition of the patient, the urgent need to relieve suffering, and the consent of the patient or healthcare proxy. Simply stated, it can be said that death with palliative sedation is "foreseen" but not "intended" and the sedation itself is not causing the death of the patient.

In a patient who is terminally ill, the physician has an obligation to provide effective palliative care, including pain control, although it may foreseeably hasten death. In 1997, the Institute for Ethics at the American Medical Association reiterated some of the fundamental tenets of ethical-medical practice for patients facing death.^[16] These tenets constitute an imperative within the healthcare professions to attend to the comprehensive needs of dying patients. These tenets are summarized in Table 1 .

In 1997, the United States Supreme Court ruled against physician-assisted suicide but maintained support for aggressive palliative care. The Supreme Court rulings Vacco v Quill 521 US 793 (1997) and Washington v Glucksberg 521 US 702 (1997) supported the concept of sedation when used to relieve intractable suffering. These decisions sanctioned the use of sedation, even to the point of rendering a patient unconscious or hastening death. It is felt that in palliative sedation, unconsciousness relieves suffering.^[17] Palliative sedation is the use of carefully titrated medications and is distinct from assisted suicide. In Supreme Court briefs opposing physician-assisted suicide, proponents for hospice and palliative care found palliative sedation to be a morally and clinically preferable last resort alternative to the relief of intractable symptoms.
The traditional approach to providing care (use of sedatives and analgesics for symptom management) for a dying patient is ethically and morally acceptable in our society. Palliative sedation in which the patient is kept unconscious as a means of relieving intractable symptoms is a different matter. One of the moral issues is that palliative sedation has many of the same risks associated with physician-assisted suicide and voluntary active euthanasia. There is concern about where the boundaries are, and there are more gray areas than not. It is clear in the literature that practitioners cannot decide on a universal definition of palliative sedation, making it more difficult to make the distinction. Opponents of palliative sedation have recommended a variety of safeguards to prevent abuse or improper use of sedation to reduce the risk among vulnerable patients. Quill et al^[18] proposed safeguards for any medical action that may hasten death. These safeguards include determining that palliative care is ineffective, obtaining informed consent, ensuring diagnostic and prognostic clarity, obtaining an independent second opinion, and documenting and reviewing the processes to ensure accountability.
The patient's family experiences moral dilemmas and is often left with the guilt and consequences of their decision or support of palliative sedation. It is frightening to think that their loved one will never wake up again. It is certainly anguishing to watch the patient die. The family may struggle with whether their loved one has already died and is just the body or shell of a person. Families may even stop visiting their loved ones after sedation is started. On the other hand, it is agonizing to watch a loved one suffer from unrelenting pain and other uncontrolled symptoms. Then there is the question of existential suffering. It would seem that the family is caught between the proverbial "rock and a hard place."
Healthcare providers are not exempt from the moral challenges of providing palliative sedation. There can be much confusion about their moral responsibility. Some of the confusion arises from previous training, the ethical tenets of doing no harm, and the desire to help provide a dignified death for the patient and family. This does not even to begin to incorporate the personal, religious, or spiritual beliefs of the healthcare provider. It is important for the care team to hold periodic conferences to help alleviate some of the emotional burden that is associated with caring for these patients at the end of life.

Two nursing organizations have explicitly stated their positions on the use of palliative sedation in EOL care. Both organizations emphasize that palliative sedation should be reserved for those whose suffering is refractory and not controlled by other appropriate palliative care measures. The intent of palliative sedation is aimed at minimizing suffering and not hastening death.
The American Nurses Association^[19] (ANA) position paper on pain management and control of distressing symptoms in dying patients provides that when restoration of health is no longer possible, the focus of nursing care is assuring a comfortable, dignified death and the highest possible quality of remaining life. One of the major fears of patients and their families as they approach death is intractable pain. The assessment and management of pain and other distressing symptoms must be based on an informed understanding of the individual patient's values and goals and his or her emotional, physical, and spiritual needs, and on an understanding of the pathophysiology of the disease state and evidence-based palliative care practice.^[20] When pain and other distressing symptoms are present, the patient should have appropriate and sufficient medication by appropriate routes to control symptoms in whatever dosage and by whatever route is needed to control symptoms as perceived by the patient.^[21] The ANA's Code of Ethics for Nurses^[22] also states that nurses may not act with the sole intent to end a patient's life even if motivated by compassion and concern for dignity and quality of life.
The Hospice and Palliative Nurses Association (HPNA) is committed to compassionate care of persons at the end of life.^[14] The HPNA position statement on palliative sedation at end of life affirms the use of palliative sedation to manage refractory and unendurable symptoms in imminently dying patients as one method of aggressive and comprehensive symptom management.

Four factors should be present for a patient to be considered for palliative sedation.
 First, the patient should have a terminal diagnosis.  
Second, the patient should have symptoms that are unbearable and refractory. 
Third, a do not resuscitate (DNR) order must be in effect. Fourth, death must be imminent (within hours to days), although this can be challenging to determine.^[17,23] If a patient meets these four factors, the patient-if able-along with the appropriate family members should have a meeting with members of the hospice or palliative care team to discuss the option of palliative sedation. It may require several meetings with the patient and family to facilitate discussion and decision making. If the patient does not have decision-making capacity, the designated healthcare proxy should be present for the meeting and approached for consent. It is important to assess the patient's and family's cultural and religious beliefs or concerns that may affect their decision regarding palliative sedation. During the meeting, it is important to discuss the options, goals, risks, and benefits of palliative sedation. An explicit treatment plan should be well documented and include the drug used, dosage, and criteria for titrating the dose. A separate consent for palliative sedation should be signed. Before proceeding with palliative sedation of patients with uncontrolled symptoms, it is imperative that careful consideration be given to establishing whether the patient's symptoms are merely difficult to control or truly refractory to reasonable palliative interventions.^[24] An ethics committee consultation may be beneficial if there is a question as to whether symptoms are refractory and palliative sedation should be initiated. The ethics committee can be useful in helping resolve conflicts within the family and can provide support for staff who may be in conflict with the decision.

A variety of medications can be used for palliative sedation ( Table 2 ). Important considerations when selecting a drug for palliative sedation include efficacy of the drug, potential untoward side effects, route of administration, cost, the symptom that is being targeted, and the preference of the provider. Medications can be used as a single agent or in combination with others to achieve the desired effect. Some of these medications can be administered by various routes. The medication selected for use is usually a benzodiazepine or barbiturate. Some of these medications are used for anesthesia or procedures that require conscious sedation. The medication selected is started at the lowest appropriate dose and titrated upward gradually to the lowest dose that provides relief or control of the refractory symptoms. Additional doses can be administered when necessary. It may become necessary to render the patient unconscious in order to alleviate suffering. All previous comfort medications the patient has been on should be continued with the initiation of palliative sedation.
Although many drugs have been used to provide effective sedation, there are currently no controlled trials comparing efficacy. Midazolam is the most commonly used drug and has efficacy as a sedative. If symptoms are not controlled with one drug, a trial of another drug is warranted. It is important to remember doses may vary since they are determined by patient weight, renal and hepatic function, hydration status, and concurrent medications.
The infusion is initiated and generally titrated to a point at which the patient seems to be comfortable and symptoms are controlled. Once the patient is sedated, medications are generally not increased unless there is evidence of renewed distress. Gradual deterioration of respiration is expected in terminal patients and should not be used solely as a reason to decrease sedation. Assessment of the patient should include the severity of suffering, level of consciousness, and untoward side effects. The frequency of assessment varies depending on the location where the patient is receiving palliative sedation (home versus inpatient facility) and the policies in place. A registered nurse assesses the patient continuously during the initiation phase of palliative sedation therapy, then less frequently once adequate sedation has been achieved.
Palliative sedation can be delivered in several different settings. Patients receiving palliative sedation can be cared for in the inpatient care setting or at home with hospice support. Administration of palliative sedation does not necessarily require admission to the hospital. Patients with refractory symptoms are often hospitalized, and 81% of the reported cases of palliative sedation occur in inpatient settings, such as a hospital or hospice.^[25] In the inpatient setting, the medications used are generally given subcutaneously or intravenously and on a continuous-rather than intermittent-schedule.
Very little literature is available on the number of palliative sedation cases being handled in the home or the process used in the home.

The nurse plays a vital role in the process of palliative sedation and EOL care. By virtue of spending more time with patients and their families than other healthcare providers, nurses are often the ones to discuss goals of care with the patient and family and represent these goals to the healthcare team. It is the nurse who ensures that the DNR document is in place and that proper consent to palliative sedation is obtained. More often than not, it is also the nurse who is the source of information and support for family members because they are often beset with inquiries and worries throughout the patient's dying process. It is pertinent for the nurse to be not only knowledgeable about palliative sedation but also sensitive to the emotional nature of this situation. The nurse links the patient and family to other members of the healthcare team so that their needs are holistically and promptly met.
The nurse plays a vital role in monitoring the patient who is receiving palliative sedation. Monitoring the patient aims to achieve comfort and symptom control. Instead of monitoring for respiratory depression, the nurse monitors for signs of respiratory distress or air hunger. Nurses must be adept at assessing the nonverbal cues that indicate ongoing pain, unrelieved symptoms, or severity of suffering. These cues may manifest as facial expressions, body movements, or agitation. The nurse should monitor the patient's level of consciousness. The eyelash reflex can be used to assess the level of sedation; the nurse makes a soft tactile stroke over the closed eyelid, which should elicit a diminished flicker or reflex. Lack of flicker indicates deep sedation, and adjustments in the dose of medication may be needed.

As the patient experiences increasing levels of sedation he or she loses protective mechanisms. Family members and caregivers need to be informed about this and the implications for care. Patients eventually lose their gag, cough, and blink reflexes. Oral intake will be difficult and pose the risk of aspiration. Eye care and oral care become important at this point to provide lubrication and moisture to oral mucous membranes of the mouth and prevent corneal irritation. A willing and capable family or caregiver can be taught the basic skills, such as oral, eye, and skin care, and positioning and other comfort measures. Providing the family or caregivers with something that they can do for the patient can be quite meaningful and can make all the difference in carrying out the wishes of the patient who wants to die at home.

Equally important as the care nurses provide to the patient is the care they provide to the family and caregivers during this stressful time. The final days and hours before a patient dies can leave a lasting impression on the family and evoke much anxiety. The nurse can alleviate some of this anxiety by providing information about what to expect during the dying process and providing compassionate care. It is important to remind the family that the signs and symptoms of the dying process only serve as a guide because each person is unique. The psychological support and power of presence that nurses have can assist with the anticipatory grieving process that most families already have started by this time.
Nurses play a vital role in the education and support of nurses and other members of the palliative care team. It is helpful for members of the team to have education and support regarding personal death awareness. Personal death awareness is defined as one's comfort with death and can be affected by personality and the cultural, social, and spiritual belief system.^[26] Nurses involved in caring for patients who are receiving palliative sedation should be allowed to abstain from doing so if they feel uncomfortable with palliative sedation because of their religious, cultural, moral, or ethical beliefs.

Palliative sedation is recognized as a valid treatment approach to the relief of intractable or refractory symptoms and is therefore firmly within the realm of good, supportive palliative care and is not euthanasia.^[26] Although it is sanctioned within our legal tenets, our professional position statements, and the core ethical principles of autonomy and beneficence as well as the doctrine of double effect and the principle of proportionality, considerable controversy surrounds its use. Nurses in hospice and palliative care need to have a basic understanding of what palliative sedation is and what it is not. Nurses play a critical role in symptom management for patients, and managing these symptoms at the end of life can be particularly challenging. By virtue of their role in the interdisciplinary care team, nurses are vital to facilitating a good death for these patients and their families. It is critical that nurses continue to advocate for their patients and provide education to other members of the healthcare team who are less knowledgeable about palliative sedation.