Terminal Sedation Compassion Amidst Ethical Uncertainties

Your Instructor Greg Burns, RN, ELNEC Phone: (866) 441-4277 or (207) 773-2947 Fax: (207) 773-3617 Email: gary@jasonprogram.org Web: www.jasonprogram.org

Outline What is Terminal Sedation? Nuances & Ethical Decisions How is is Done?

What is Terminal Sedation?

Nuances & Ethical Decisions

How is is Done?

General Concept 1992 -- When all else fails: 17 year old girl with relapsed Ewing's sarcoma, multiple bony metastases, pelvic mass compressing her spine and causing bilateral leg paralysis, constant severe bone, abdominal, and pelvic pain. Cannot swallow. Morphine drip at 1000 mg/hour and no pain relief or sedation. Fentanyl and Dilaudid were ineffective. When this happened, ketamine and Precedex were unavailable. The anesthesia team could not place a catheter due to the large tumor burden. What can be done?

Barbiturates in the Care of The Terminally ill Barbiturates: Reliably produce sedation and unconsciousness ( comfort ) Are used in the execution of prisoners by lethal injection Ethical Considerations: The Principle of Double Effect -- Distinction between intended effects and unintended although foreseen effects. If comfort care is the only intended effect, then Truog, Robert D., et. al. NEJM, 1992, Vol. 327, No. 23, 1678-81

Barbiturates:

Reliably produce sedation and unconsciousness ( comfort )

Are used in the execution of prisoners by lethal injection

Ethical Considerations:

The Principle of Double Effect -- Distinction between intended effects and unintended although foreseen effects.

If comfort care is the only intended effect, then

Truog, Robert D., et. al. NEJM, 1992, Vol. 327, No. 23, 1678-81

Barbiturates Are Justified To relieve physical suffering when all reasonable alternatives have failed To produce unconsciousness before terminal extubation Produce deep sedation and unconsciousness as a means of relieving nonphysical suffering

To relieve physical suffering when all reasonable alternatives have failed

To produce unconsciousness before terminal extubation

Produce deep sedation and unconsciousness as a means of relieving nonphysical suffering

So Let’s See What The Ethicists Have to Say Since Then

2008 - Understanding Terms and Attitudes Survey among experts in the field of medical ethics (German Academy for Ethics in Medicine) 73% of the respondents would only speak of “terminal sedation” when sedation until death is intended 27% would also use the term when the patient is sedated at the time of death, without sedation until death explicitly intended in the first place. Attitudes towards terminal sedation: an empirical survey among experts in the field of medical ethics. BMC Palliative Care 2007

Survey among experts in the field of medical ethics (German Academy for Ethics in Medicine)

73% of the respondents would only speak of “terminal sedation” when sedation until death is intended

27% would also use the term when the patient is sedated at the time of death, without sedation until death explicitly intended in the first place.

Preference for the different terms with medical background without medical background “ Sedation at the end of life” 38% 36% “ Palliative sedation” 53% 41% “ Terminal sedation” 32% 46% Conclusion

It’s a close call… and often the answer changes

No consistent terminology and no consistent definition of the term In the long run, a more consistent and precise terminology is desirable. We recommend to use the terms "palliative sedation" and "terminal sedation" as synonyms for treatments aiming to control untreatable symptoms in (pre-)terminal patients by reduction of consciousness. In all other cases of medically indicated sedation we recommend to speak only of sedation. Attitudes towards terminal sedation: an empirical survey among experts in the field of medical ethics. BMC Palliative Care 2007

In the long run, a more consistent and precise terminology is desirable.

We recommend to use the terms "palliative sedation" and "terminal sedation" as synonyms for treatments aiming to control untreatable symptoms in (pre-)terminal patients by reduction of consciousness.

In all other cases of medically indicated sedation we recommend to speak only of sedation.

Need Only Two Choices “ Palliative or terminal sedation” Control otherwise untreatable symptoms “ Sedation” All other types of sedation No consensus yet – describing your viewpoint will help clarify the issue

“ Palliative or terminal sedation”

Control otherwise untreatable symptoms

“ Sedation”

All other types of sedation

No consensus yet – describing your viewpoint will help clarify the issue

Attitudes The cultural background determines attitudes, viewpoints on goals of care, and in which situations of "intolerable suffering" sedation is ethically acceptable. “… it must be clear to all, that the intention of sedation in the terminal and final phase is not a concealed form of euthanasia.” Attitudes towards terminal sedation: an empirical survey among experts in the field of medical ethics. BMC Palliative Care 2007 The Culture of Early Christianity

The cultural background determines attitudes, viewpoints on goals of care, and in which situations of "intolerable suffering" sedation is ethically acceptable.

“… it must be clear to all, that the intention of sedation in the terminal and final phase is not a concealed form of euthanasia.”

Attitudes: Physical vs. Mental/Emotional Suffering Moral evaluation of different scenarios M=medical professional ØM = Non-medical background Dying patient Acceptable Not acceptable Don't know M øM M øM M øM Physical suffering Only sedation 98 97 1 1 1 1 Sedation + withdrawal of nutrition 86 89 12 8 3 3 Only withdrawal of nutrition 92 95 6 5 3 0 Mental suffering Only sedation 61 52 23 39 16 9 Sedation + withdrawal of nutrition 55 44 29 46 16 10 Only withdrawal of nutrition 68 63 21 22 11 14

Attitudes: Physical vs. Mental/Emotional Suffering Moral evaluation of different scenarios M=medical professional ØM = Non-medical background Patient with unfavourable prognosis Acceptable Not acceptable Don't know M øM M øM M øM Physical suffering Only sedation 74 66 17 23 9 11 Sedation + withdrawal of nutrition 63 56 28 30 9 14 Only withdrawal of nutrition 78 71 17 22 5 7 Mental suffering Only sedation 37 36 43 47 20 18 Sedation + withdrawal of nutrition 32 27 48 52 20 21 Only withdrawal of nutrition 52 50 34 39 14 12

Morally Difficult Decisions The survey shows that acceptance of terminal sedation decreases when the patient is not yet dying, when sedation is used because of uncontrollable mental suffering, and when life-sustaining measures are terminated during sedation. Furthermore, the fact should be considered that the withdrawal of nutrition under sedation was regarded more morally problematic than the withdrawal of nutrition without sedation.

The survey shows that acceptance of terminal sedation decreases when the patient is not yet dying, when sedation is used because of uncontrollable mental suffering, and when life-sustaining measures are terminated during sedation.

Furthermore, the fact should be considered that the withdrawal of nutrition under sedation was regarded more morally problematic than the withdrawal of nutrition without sedation.

Conclusion Our survey showed that for the studied medical ethics experts terminal sedation involves considerable moral uncertainties. This results in a further need for medical and medical ethics research and discussion.

Our survey showed that for the studied medical ethics experts terminal sedation involves considerable moral uncertainties. This results in a further need for medical and medical ethics research and discussion.

Careful – People have opinions, and end-of-life issues generate powerful opinions. Could anyone be thinking that you want to euthanize the patient? Communicate well!

Policies are scarce National Guideline Cleaning House has none AAP Policy BMC Med Ethics article (ICU) Length of stay data Hospice & Palliative Care Federation of Massachusetts Palliative Sedation Protocol

National Guideline Cleaning House has none

AAP Policy

BMC Med Ethics article (ICU)

Length of stay data

Hospice & Palliative Care Federation of Massachusetts Palliative Sedation Protocol

AAP Policy Statement Hastening Death The decision to forgo life-sustaining medical treatment does not necessarily imply an intent or choice to hasten the death of a child. On occasion, the relief of severe, progressive symptoms such as pain or dyspnea may require a rapid escalation in the doses of administered analgesics and sedatives. Rarely, the relief of progressive symptoms may require deep sedation. Dying with dignity and without pain or distress is the primary goal. The AAP is concerned about reports of involuntary euthanasia of infants and young children and of physician-assisted suicide of adolescents. The AAP does not support the practice of physician-assisted suicide or euthanasia for children. AMERICAN ACADEMY OF PEDIATRICS:Palliative Care for Children PEDIATRICS Vol. 106 No. 2 August 2000, pp. 351-357

Hastening Death

The decision to forgo life-sustaining medical treatment does not necessarily imply an intent or choice to hasten the death of a child.

On occasion, the relief of severe, progressive symptoms such as pain or dyspnea may require a rapid escalation in the doses of administered analgesics and sedatives. Rarely, the relief of progressive symptoms may require deep sedation. Dying with dignity and without pain or distress is the primary goal.

The AAP is concerned about reports of involuntary euthanasia of infants and young children and of physician-assisted suicide of adolescents. The AAP does not support the practice of physician-assisted suicide or euthanasia for children.

Consensus guidelines on analgesia and sedation in dying intensive care unit patients BMC Med Ethics. 2002; 3: 3. Published online 2002 August 12. 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.

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.

Consensus guidelines on analgesia and sedation in dying intensive care unit patients BMC Med Ethics. 2002; 3: 3. Published online 2002 August 12. The intention of the Intensivists administering narcotics/sedatives: the patient's medical condition and reasons leading to the initiation of palliative care the goal, which is to relieve pain and suffering the way pain and suffering will be evaluated 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.

The intention of the Intensivists administering narcotics/sedatives:

the patient's medical condition and reasons leading to the initiation of palliative care

the goal, which is to relieve pain and suffering

the way pain and suffering will be evaluated

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.

Further Support of Palliative Sedation Data that shows that palliative sedation does not hasten death (and is thus clearly not euthanasia)

Data that shows that palliative sedation does not hasten death (and is thus clearly not euthanasia)

Sedation in palliative care – a critical analysis of 7 years experience BMC Palliative Care 2003, 2: 2 - No difference was found in the duration of stay in our unit until death between those patients who died with, and those who died without sedation. % patients receiving palliative sedation

Requirements for Palliative Sedation – Doctrine of Double Effect The nature of the act must be good or at least morally neutral. Providing sedation to comfort. The intention of the agent is the good effect. The bad effect may be foreseen and tolerated, but not intended. Providing sedation to comfort, and thereafter the patient dies from respiratory failure.

The nature of the act must be good or at least morally neutral.

Providing sedation to comfort.

The intention of the agent is the good effect. The bad effect may be foreseen and tolerated, but not intended.

Providing sedation to comfort, and thereafter the patient dies from respiratory failure.

Doctrine of Double Effect The bad intent may not be the means to the good effect. Prescribing a lethal dose of barbiturates causes the patient’s death, relieving the pain. The good effect must outweigh the bad effect.

The bad intent may not be the means to the good effect.

Prescribing a lethal dose of barbiturates causes the patient’s death, relieving the pain.

The good effect must outweigh the bad effect.

Requirements for Palliative Sedation Patient suffering despite the use of all available effective treatments Assure you adhere to the Doctrine of Double Effect Understand & adhere to the patient’s wishes Document your plan for the patient Document the patient’s consent/assent Seek an IDT meeting with an ethics consult Can be done in home with continual nursing presence for at least 24 hours example: Hospice & Palliative Care Federation of Massachusetts Palliative Sedation Protocol

Patient suffering despite the use of all available effective treatments

Assure you adhere to the Doctrine of Double Effect

Understand & adhere to the patient’s wishes

Document your plan for the patient

Document the patient’s consent/assent

Seek an IDT meeting with an ethics consult

Can be done in home with continual nursing presence for at least 24 hours

A Different Approach

A Continuum of Palliative Care If palliative care is simply aggressive pharmacology to relieve pain, it will sometimes fail. Sometimes pain is “existential”, and medications do not help. The authors believe palliative care will never fail if palliative sedation is understood as the final therapy, where there can be no failure. Thus physician-assisted dieing is never needed Palliative Sedation as Part of a Continuum of Palliative care. J. Pall. Care Vol.1, Nov 1, 2008

If palliative care is simply aggressive pharmacology to relieve pain, it will sometimes fail.

Sometimes pain is “existential”, and medications do not help.

The authors believe palliative care will never fail if palliative sedation is understood as the final therapy, where there can be no failure.

Thus physician-assisted dieing is never needed

REPORT OF THE COUNCIL ON ETHICAL AND JUDICIAL AFFAIRS - 2006 “ Palliative sedation to unconsciousness is an important tool in the armamentarium of palliative medicine…. It is medically and ethically acceptable under specific, relatively rare circumstances. Because palliative sedation to unconsciousness is intended to be maintained until the patient’s death, it should be used only as a therapy of last resort for relief of severe, unrelenting clinical symptoms after the failure of other aggressive interventions, including psycho-social support. 7 It is important to ensure that patients are indeed at the end stage of a terminal illness and that other forms of symptom-specific treatment are not effective. It is most appropriate as part of a multi-disciplinary mode of palliative care that addresses the whole patient in the context of that patient’s family system, spiritual beliefs and values. It is not appropriate for suffering that is mainly existential.”

“ Palliative sedation to unconsciousness is an important tool in the armamentarium of palliative medicine…. It is medically and ethically acceptable under specific, relatively rare circumstances. Because palliative sedation to unconsciousness is intended to be maintained until the patient’s death, it should be used only as a therapy of last resort for relief of severe, unrelenting clinical symptoms after the failure of other aggressive interventions, including psycho-social support. 7 It is important to ensure that patients are indeed at the end stage of a terminal illness and that other forms of symptom-specific treatment are not effective. It is most appropriate as part of a multi-disciplinary mode of palliative care that addresses the whole patient in the context of that patient’s family system, spiritual beliefs and values. It is not appropriate for suffering that is mainly existential.”

Prescribing terminal sedation Adults: Slowly increasing doses of midazolam 0.5 mg – 8 mg/h iv (or other benzodiazepine), aimed at achieving effective symptom control Pediatrics: Anecdotally, most providers use barbiturates: Pentobarbital Barbiturates are capable of producing all levels of CNS mood alteration from excitation to deep coma. Overdosage can produce death. Barbiturates are respiratory depressants. The degree of respiratory depression is dependent upon dose.

Adults: Slowly increasing doses of midazolam 0.5 mg – 8 mg/h iv (or other benzodiazepine), aimed at achieving effective symptom control

Pediatrics: Anecdotally, most providers use barbiturates:

Pentobarbital

Barbiturates are capable of producing all levels of CNS mood alteration from excitation to deep coma. Overdosage can produce death.

Barbiturates are respiratory depressants. The degree of respiratory depression is dependent upon dose.

Pentobarbital continued Following IV administration, the onset of action is 1-5 minutes The plasma half-life for pentobarbital in adults is 15 to 50 hours and appears to be dose dependent The duration of each IV injection is 15-45 minutes The recommended pediatric dosage ranges from 2 to 6 mg/kg as a single IM injection not to exceed 100 mg Translated to palliative sedation: Dosing is titrated to comfort, and thus the effective dose may vary with the situation 1-3 mg/kg slow IV push X 1 and repeat every 2-5 min until adequate sedation. Further scheduled based on patient responses Consider a continuous infusion based on initial result – 0.5-1 mg/kg/hour is a reasonable starting dose; 1-3 mg/kg/hr is used for barbiturate coma. Ongoing observations & adjustments to maintain comfort

Following IV administration, the onset of action is 1-5 minutes

The plasma half-life for pentobarbital in adults is 15 to 50 hours and appears to be dose dependent

The duration of each IV injection is 15-45 minutes

The recommended pediatric dosage ranges from 2 to 6 mg/kg as a single IM injection not to exceed 100 mg

Translated to palliative sedation:

Dosing is titrated to comfort, and thus the effective dose may vary with the situation

1-3 mg/kg slow IV push X 1 and repeat every 2-5 min until adequate sedation. Further scheduled based on patient responses

Consider a continuous infusion based on initial result – 0.5-1 mg/kg/hour is a reasonable starting dose; 1-3 mg/kg/hr is used for barbiturate coma.

Ongoing observations & adjustments to maintain comfort

WARNINGS Barbiturates may be habit forming IV administration Too rapid administration may cause respiratory depression, apnea, laryngospasm, or vasodilation with fall in blood pressure. Acute or chronic pain Paradoxical excitement could be induced or important symptoms could be masked. However, the use of barbiturates as sedatives in the postoperative surgical period and as adjuncts to cancer chemotherapy is well established. Use in pregnancy Barbiturates can cause fetal damage when administered to a pregnant woman.. Withdrawal symptoms occur in infants born to mothers who receive barbiturates throughout the last trimester of pregnancy.

Barbiturates may be habit forming

IV administration

Too rapid administration may cause respiratory depression, apnea, laryngospasm, or vasodilation with fall in blood pressure.

Acute or chronic pain

Paradoxical excitement could be induced or important symptoms could be masked. However, the use of barbiturates as sedatives in the postoperative surgical period and as adjuncts to cancer chemotherapy is well established.

Use in pregnancy

Barbiturates can cause fetal damage when administered to a pregnant woman..

Withdrawal symptoms occur in infants born to mothers who receive barbiturates throughout the last trimester of pregnancy.

Further considerations Bispectral index monitor: uses processed EEG signals to measure sedation depth scale from 0 to 100 - 0, coma; 40 to 60, general anesthesia; 60 to 90, sedated; 100, awake. Propofol likely too expensive

Bispectral index monitor: uses processed EEG signals to measure sedation depth scale from 0 to 100 - 0, coma; 40 to 60, general anesthesia; 60 to 90, sedated; 100, awake.

Propofol likely too expensive

Now you can do the right thing… Even if it is sad R.M.A

Thank you for listening If you even need help, you can easily find us: The Jason Program 65 Washington Avenue Portland, ME 04101 Phone: (207) 773-2947 or (866) 441-4277 Fax: (207) 773-3617 Email: [email_address] or [email_address] Web: www.jasonprogram.org ************************************************************************