Embargo: 12:01 a.m. EDT, Monday September 16, 2002

Intensive care unit physicians need to be comfortable prescribing drugs in whatever dose is needed to relieve a dying patient's pain and suffering, even if this hastens the patient's death, according to proposed new guidelines released today by researchers at an international medical ethics think-tank.

The guidelines identify the intent of the physician administering narcotics and sedatives as the most crucial distinction between palliative care – managing pain and suffering but not treating the underlying illness – and assisted death (euthanasia/assisted suicide).

The recommendations are contained in a study by the University of Toronto Joint Centre for Bioethics (JCB) to develop consensus guidelines on analgesia and sedation in dying intensive care unit (ICU) patients.  Designed to help distinguish palliative care from euthanasia, the study is based on input from a panel of Canada's leading intensive care physicians and the deputy chief coroners of five provinces.

"ICU physicians walk a very thin line," said JCB director Peter Singer. "If they administer too little analgesia and sedation to control their dying patients' distress, they provide inadequate palliative care and patients suffer. If they administer too much, they risk prosecution for committing euthanasia.

"No one should die in pain," said Dr. Singer. "We hope that these guidelines will make it less likely that anyone does."

The study was led by Dr. Laura Hawryluck, Assistant Professor of Medicine and Critical Care Physician, University Health Network, and leader of the Ian Anderson Program, training roughly 10,000 Canadian primary care physicians to deal with issues surrounding death and dying such as pain control in terminally ill patients, decision-making at the end of life and support of dying patients and their families.

Dr. Hawryluck said growing legal scrutiny had increased fear of prosecution and could perpetuate the under-treatment of pain and suffering at the end of life.

"Many family members worry that a loved one may die in pain," she added.  "These guidelines also help them by offering clear standards and aiding the understanding of people concerned that a loved one's death may be hastened by allowing doctors to give them morphine."

The study was prompted by cases of euthanasia and alleged euthanasia and the JCB researchers’ concern that such cases were creating a chill with respect to administering appropriate levels of drugs in end-of-life palliative care.

"There have been cases of euthanasia in Canada," Dr. Hawryluck said, "and coroners may be concerned about the administration of high doses of opiates and benzodiazepines – and whether the intent was to kill or to palliate – when the reasons for giving those drugs in those dosages are not made clear.

"That is why coroners were invited to participate in formulating these guidelines – to increase understanding between those who administer care and those who ultimately review the care received."

Said Dr. Singer: "If you are a physician practicing good palliative care, you get a quality award.  If you are committing euthanasia, you go to jail.  We should have a pretty bright line separating these two acts and we don’t – especially in the ICU.  That is what these guidelines provide."

Several guidelines recommended in the study deal with controversial areas such as the use of neuromuscular blockers1  that mask the clinical signs of pain and suffering, "terminal" sedation and the principle of "double effect," a term used by medical organizations around the world to describe a situation in which physicians administer large doses of drugs to alleviate pain and suffering even though this may also hasten death.

On this issue, the guidelines state that: "If the amount of narcotics/sedatives required to relieve pain and suffering at the end of life may foreseeably cause hastening of death, although the physician's intent is solely to relieve suffering, this should be considered palliative care."

Addressing the crucial question of the physician's intent, the study concedes that since someone's intent can never be completely understood by others, "the border between palliative care and euthanasia may never be crystal clear."

However, "documentation in the patient's chart of how analgesics and sedatives will be used to palliate, and evidence that these drugs were used appropriately, are the best and only available ways to assess the [physician's] intent when treating dying patients," the study says.

The guideline on "terminal sedation" states that the practice is palliative care, not euthanasia. Defined in medical literature as sedation with continuous intravenous narcotics and/or sedatives until the patient becomes unconscious and death ensues from the underlying illness, terminal sedation "may make the detection of euthanasia/assisted suicide more difficult," the report concedes. Once again, the intent of the physician is crucial.

To develop the guidelines, Dr. Hawryluck used the Delphi technique2  with 26 participants in three panels:

1. Nine Canadian Academic Adult Intensive Care Fellowship program directors and Intensive Care division chiefs in academic centers without a training program.
2. Five Provincial Deputy Chief Coroners/Medical Examiners.
3. A "validation panel" of 12 intensivists who attended a Canadian Critical Care Trials Group meeting in April 1999.

After three Delphi rounds, the participants reached consensus on 16 statements covering:

• The role of palliative care in the ICU;
• The management of pain and suffering;
• Current areas of controversy;
• Ways of improving palliative care in the ICU setting; and
• Ways of distinguishing palliative care from euthanasia and assisted suicide.

"We believe our consensus guidelines on analgesia and sedation in dying ICU patients are the first of their kind developed using consensus methods and involving coroners," said Dr. Hawryluck.

The 16 consensus statements on the use of analgesia and sedation in dying ICU patients are:

A. Palliative Care in the ICU

1. Palliative Care in the ICU

• Good Intensive Care must seek to provide relief of pain and suffering for ALL Intensive Care Unit (ICU) patients, not solely for those for whom death is inevitable. The palliation of dying patients in the ICU is different from palliative care in other settings since the dying process tends to be more dramatic and the time from withholding/withdrawing active disease treatment to death is much shorter. Ensuring good palliative care in the ICU is crucial.

• The goals of palliative care in the ICU are: 1) relief of pain, 2) relief of agitation and anxiety, 3) relief of dyspnea (shortness of breath), 4) psychological and spiritual support of patient and family and, 5) provision of comfort by changing the technological ICU environment to a more comfortable, peaceful one. Patients’ wishes, including those expressed by advance directives, must be respected by the medical team.

• Pain and suffering are different. The ability to assess a patient’s pain and suffering is crucial, yet these skills are poorly taught, if taught at all. In the Intensive Care Unit, pain assessment is rendered even more difficult by: 1) communication problems imposed by the ICU environment, 2) the severity of illness and the presence of multisystem organ failure, 3) decreased level of consciousness of patients as a result of illness and drugs, 4) our own lack of knowledge/difficulty in interpretation of clinical signs, and, 5) the unreliability of clinical signs. Suffering, because of its even greater individual nature, is harder to assess. Since the assessment of suffering may not be easily amenable to teaching, what must be taught is respect for others’ values; values through which individual suffering is perceived. Intensivists need to be aware of the abilities of their ICU staff in assessing and ensuring adequate relief of pain and suffering. Education, research and discussions with family members may be invaluable in improving the abilities of physicians and nurses to determine patient suffering.

4. Relief of Pain and Suffering

• In order to relieve pain and suffering at the end-of-life, both pharmacological and non-pharmacological means should be used. Non-pharmacological interventions include ensuring the presence of family, friends and pastoral care (if desired), and, changing the technological ICU environment to a more private and peaceful one. Nursing interventions and accommodating patients’ religious and cultural beliefs also play an important role in alleviating pain and suffering. Pharmacological interventions include any analgesics, sedatives or other adjuncts that will decrease discomfort. In general, narcotics are used for pain; benzodiazepines are used for agitation and anxiety. If the patient is experiencing pain and suffering, both analgesics and sedatives are used. This combination of drugs may provide better relief of pain and suffering at the end-of-life than either class of drug alone.

• Most ICU patients require narcotics and sedatives in order to ease the pain and suffering associated with their critical illness. The amount of drugs needed varies on an individual basis.  As in active disease treatment, palliative care MUST be individualized.  Considerations affecting the initial dose of narcotics and sedatives in palliation include: 1) the patient's previous narcotic exposure since tolerance develops quickly, 2) age, 3) previous alcohol or drug use and/or abuse, 4) underlying illness, 5) underlying organ dysfunction 6) the patient's current level of consciousness/ sedation, 7) level of available psychological/spiritual support, and, 8) patients’ wishes regarding sedation.

• Once analgesics and sedatives are initiated, they are increased in response to 1) patient's request, 2) signs of respiratory distress, 3) physiological signs: unexplained tachycardia (accelerated heart rate), hypertension, diaphoresis (perspiration), 4) facial grimacing, tearing, vocalizations with movements, turns or other nursing care, and 5) restlessness. These clinical indicators, although crucial for graduated therapy, are imprecise. Ramsay or Likert scales, despite   their limitations, may provide additional help in evaluating the patient’s discomfort.  The total amount of drugs required for any individual patient  may far exceed any preconceived notions of "usual," in reality non-existent, doses.

• No maximum dose of narcotics or sedatives exists. The goal of palliative care is to provide relief of pain and suffering and whatever the amount of drugs that accomplishes this goal is the amount that is needed for that individual patient.  By refusing to define a maximal dose of analgesics or sedatives, our goal is to ensure that Intensivists will use the required dose for each patient. If a maximal dose is ever declared, some patients will be in pain and will be suffering at the end-of-life because of the Intensivist's fears of litigation if this maximal dose is exceeded. Therefore, the intent of the physician administering the drugs becomes important in distinguishing between palliative care and assisted death (euthanasia/assisted suicide).

• Support for both approaches exists among Intensivists on this panel. The treatment of signs and symptoms of pain and suffering is good palliative care. When appropriate doses of narcotics and sedatives are used and the intent of the physician is clear and well documented, pre-emptive dosing in anticipation of pain and suffering is not euthanasia nor assisted suicide but good palliative care.

9. Special Situations

• Neuromuscular blockers mask the clinical signs of pain and suffering delineated above. When possible, the withholding and withdrawal of life support should be started after their effects wear off in order to permit Intensivists to assess as accurately as possible the patient’s pain and suffering and ensure good palliative care. If neuromuscular blockers were not in use, they should not be started in order to hide patient distress. The intent and justifications of Intensivists who fail to wait for neuromuscular blockers to wear off or who fail to reverse them must be carefully documented. Since patients in persistent vegetative states are deemed incapable of feeling pain or anxiety, sedatives and narcotics are usually not required during the withholding/withdrawal of life support. The family’s perceptions of pain and suffering, however, may play a role in the use of narcotics and sedatives in these patients.

• Terminal sedation, defined in the literature as sedation with continuous IV narcotics and/or sedatives until the patient becomes unconscious and death ensues from the underlying illness, is palliative care, not euthanasia. Since terminal sedation may arguably make the detection of euthanasia/assisted suicide more difficult, the intent of the Intensivist is crucial.

• The intention of the Intensivist administering narcotics/sedatives to palliate dying patients can be assessed by careful documentation in the chart of: 1) the patient's medical condition and reasons leading to the initiation of palliative care, 2) the goal, which is to relieve pain and suffering, 3) the way pain and suffering will be evaluated, and 4) the way in which drugs will be increased and why. Intensive care units should develop guidelines governing the process of withholding and withdrawal of life support and Intensivists should justify and document any need to deviate from the policy and the anticipated modifications. The administration of drugs without any palliative benefit, e.g. lethal doses of potassium chloride or neuromuscular blockers, suggests an intent to euthanize/assist in the suicide of an individual patient.

• If the amount of narcotics/sedatives required to relieve pain and suffering at the end-of-life may foreseeably cause hastening of death, although the physician's intent is solely to relieve suffering, this should be considered palliative care.

• The intent of the physician administering narcotics and sedatives to the dying patient is the most crucial distinction between palliative care and assisted death (euthanasia/assisted suicide). In order to avoid any misinterpretations, Intensivists must clearly document, in the patient’s chart, their intentions and justify their actions during the withholding/withdrawal process.

14. How Can We Improve our Abilities and our Consistency in Assessing and Treating Pain and Suffering?

• Open discussions involving all members of the health care team and family, consulting and sharing when faced with difficult cases, improvements in education and research are needed. The development of a process to review our performance in palliative care within each ICU and national consensus guidelines will also improve our skill in assessing pain and suffering and improve our abilities to relieve it at the end-of-life.

• The importance of psychological and emotional support for the ICU staff involved in palliating a dying patient is frequently overlooked. Developing a supportive working group, open communication and regular debriefings among members of the ICU team is crucial. The ICU social worker, pastoral care representative and, within the hospital, the departments of psychiatry and psychology may also be very helpful in enabling the ICU staff to continue to provide good palliative care.

• Currently a formal Palliative Care consult is rarely requested during the withholding and withdrawal of life support. If the expertise exists within the ICU, such a consult is not required.  A Palliative Care Medicine consultation could be useful to: 1) treat symptoms that are difficult to control, 2) treat difficult pain syndromes, 3) provide guidance on the use of adjuncts that we, as Intensivists, use infrequently in the dying process, 4) provide guidance when using analgesics/sedatives infrequently administered, 5) help when significant psychological issues within the family or health care team are evident, 6) provide guidance in ICUs where the practices of withholding/withdrawal of care is infrequent, 7) help ease the patient’s transfer to the ward if he/she survives the withholding/withdrawal process, and 8)  provide ongoing help in relieving pain and suffering when death is protracted.

University of Toronto
Joint Centre for Bioethics
Innovative. Interdisciplinary. International. Improving health care through bioethics.

The JCB is a partnership among the University of Toronto  and eight fully affiliated hospitals.

The centre's mission is to provide leadership in bioethics research, education, and clinical activities. Its vision is to be a model of interdisciplinary collaboration in order to create new knowledge and improve practices with respect to bioethics. The JCB does not advocate positions on specific issues, although its individual members may do so.

The goals of the JCB are:

• To foster interdisciplinary research and scholarship, link education to research, and disseminate research findings to improve policies and practices.
• To support undergraduate, graduate and postgraduate educational programs in bioethics.
• To support clinical ethics activities including continuing education for health care providers, ethics committees, ethics consultation, and projects to address specific issues arising in JCB hospitals.
• To foster collegial discussion of bioethics issues throughout the JCB participating institutions, and to serve as a resource for the media, policymakers, and community groups.

More information is available at http://www.utoronto.ca/jcb/

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