1. Exploring Palliative Sedation The What, Why, When, and How? Debra Nobbe, RN, CNS, ACHPN dnobbe@hospicewr.org Brian Bagley-Bonner, MDiv bbonner#@hospicewr.org

2. Objectives  Define and discuss Palliative Sedation by reviewing current evidenced based research  Explore legal and ethical precedents

3. Objectives  Discuss Hospice of the Western Reserve’s Practice and Procedure  Discuss refractory pain and suffering by building on a holistic model

4. One Definition Palliative Sedation is the monitored use of medications to relieve refractory and unendurable physical, spiritual and psycho- social distress for patients with a terminal diagnosis, by inducing varied degrees of unconsciousness. The purpose of the medication is to provide comfort and relieve suffering and not to hasten death. - Hospice and Palliative Care Federation of Massachusetts.

5. Levels of Sedation  3 levels of sedation – Mild (Somnolence) pt awake - level of consciousness lowered – Intermediate/Respite (stupor) pt asleep but can be woken to communicate briefly – Deep (coma) the patient is unconscious and unresponsive DeGraeff & Dean

6. Precedents to Consider  Legal  Ethical

7. Legal Precedent 1997 US Supreme Court ruled: “a patient who is suffering from a terminal illness and who is experiencing great pain has no legal barriers to obtaining medication, from qualified physicians, to alleviate suffering, even to the point of causing unconsciousness and hastening death…”

8. Ethical Principles  Double Effect  Beneficence

9. Why? To alleviate a patient’s pain and suffering.

10. Cycle of Pain and Suffering Emotional SocialSpiritual PhysicalPain Suffering

11. Sedation as a Side Effect Sedation as Primary Means of Reducing Suffering How Can We Stop the Cycle? Physician Assisted Suicide (PAS) as Primary Means of Ending Suffering

12. Meds cause drowsiness Meds allow sleep Respite Sedation Medsensuresleep Palliative Sedation P A S Double Effect

13. Sedation as a Side Effect Sedation as Primary Means of Reducing Suffering Physician Assisted Suicide (PAS) as Primary Means of Ending Suffering

14. Who? Assessing Appropriateness:  Terminal Illness  Symptoms  Dyspnea  Delirium/Agitation  Physical Pain  N/V and Uncontrolled Bleeding  Anxiety/psychological distress *  * Not The American Medical Association (AMA)

15. When? How to determine when a symptom is truly refractory? – Are further interventions capable of providing relief? – Is the anticipated acute or chronic morbidity of the intervention tolerable to the patient? – Are the interventions likely to provide relief within a tolerable time frame? *J. Hallenbeck, MD National Ethics Tele-Conference 7/26/06

16.  30 years old  Stage 4 lymphoma  Drug/Alcohol Abuse  Juvenile Behavior  Limited Coping Skills  Multiple Wounds  Refractory Pain/Anxiety w/dressing changes  Breaking Cycle

17. Hospice of the Western Reserve’s Practice and Procedure Purpose – To safely and effectively induce and monitor palliative sedation (lowered conscious awareness) as a means to manage refractory symptoms. The determination of when palliative sedation is being utilized is based solely on the intent for which it is prescribed, rather than the medication used, the dose, or the route by which it is given.

18. Hospice of the Western Reserve’s Practice and Procedure  Procedure Requirements – Define refractory symptom (s) – DNRCC in effect – Patient/Family Education – Review/complete psychosocial and spiritual assessment

19. How? Medications “ The choice of an agent is dependent, for the most part, upon clinical institutional policy and formulary restrictions. Also in difficult cases a second medication may be needed to sedate a patient adequately. Medications may be administered sublingually, rectally, intravenously or subcutaneously.” Rousseau End of Life Online Curriculum

20. Medications  Patient goal drives titration phase  State and Federal Laws

21. Benzodiazepines  Lorazepam (Ativan)  Midazolam (Versed)

22. Antipsychotic  Chlorpromazine (Thorazine)

23. Butyrophenone  Haloperidol (Haldol)

24. Barbiturates  Phenobarbital

25. Medications and Suggested Doses for Palliative Sedation DrugSuggested Dose (a) Midazolam0.5-5 mg bolus IV/SC, then CII/CSI at 0.5-1 mg/h; usual maintenance dose, 20-120 mg/d Lorazepam0.5-2 mg PO, SL, or SC every 1-2 hours OR 1-5 mg bolus IV/SC, then CII/CSI at 0.5-1 mg/h; usual maintenance dose, 4-40 mg/d Chlorpromazine10-25 mg PO, IV, or PR every 2-4 hours Haloperidol0.5-5 mg PO or SC every 2-4 hours OR 1-5 mg bolus IV/SC, then CII/CSI at 5 mg/d; usual maintenance dose, 5-15 mg/d Pentobarbital60-200 mg PR every 2-4 hours OR 2-3 mg/kg bolus IV, then CII at 1 mg/h; titrate upward to maintain sedation Thiopental5-7 mg/kg bolus IV, then CII at 20 mg/h; usual maintenance dose, 70-180 mg/h Propofol10 mg/h as CII; may titrate by 10 mg/h every 15-20 minutes; bolus of 20-50 mg may be used for emergency sedation a Clinicians should consult pharmacy textbooks, pharmacists, and other knowledgeable professionals for further dosing suggestions. PO=oral; PR = per rectum; SL=sublingual; SC=subcutaneous; CII=continuous intravenous infusion; CSI=continuous subcutaneous infusion. Rousseau P. 2004 used with permission

26. Hastening Death? Recent studies have found no difference in survival between hospice patients who required sedation for intractable symptom control during their last days and those who did not. M. Maltone, C Pittureri, L Piccinini et all.

27. Implementation into Practice  Intent  Individualized  Education - early conversations Emotional SocialSpiritual Physical

28. In Summary Patients need and deserve assurance that suffering will be effectively addressed, as both the fear of suffering and the suffering itself add to the burden of the terminal illness - AAHPM position Statement 9/15/2006b

29. References  Slide 2 – Palliative Sedation Protocol -Resources and conferences -Best Practices – Reports – Hospice and Palliative Care Federation of Massachusetts Web Page http://www.hospicefed.org  Slide 3 – DeGraef A and Dean M, Palliative Sedation Therapy in the Last Weeks of Life; A Literature Review and Recommendations for Standards, Journal of Palliative Medicine, vol 10 Number 1, 2007  Slide 7 - Compassion in Dying v Washington, 79 F3d 790 (9th Cir 1996) (en banc) and Quill v Vacco, 830 F3d 716 (2nd Cir 1996).  Slide 14 – AMA meeting: AMA OKs palliative sedation for terminally ill. O’Reilly, K, amednews.com July 7,2008  Slide 15 –Hallenbeck J, MD http://www.ethics.va.gov/pubs/netsum.asp National Ethics Tele- Conference 7/26/06  Slide 19 -Rousseau P. Existential suffering and palliative sedation: a brief commentary with a proposal for clinical guidelines. American Journal of Hospice and Palliative Care 2001;18:226-228

30. References  Slide 24 - Maltoni M, Pittureri C, Piccinini L et al. Palliative sedation therapy does no hasten death: results from a prospective multicenter study Annals of Oncology 2009 20:1163-1169  Slide 25 – Rousseau P. Palliative Sedation in the management of refractory symptoms. J Support Oncol. 2004 Mar-Apr; 2(2):181-6  Kirk T, Mahon M, NHPCO Positions Statement and Commentary on the Use of Palliative Sedation in Imminently Dying Terminally Ill Patients. Journal of Pain and Symptom Management Special Article 2010 doi 10.1016/j.jpainsymman.201.01.009  Seale, C Continuous Deep Sedation in Medical Practice. Journal of Pain and Symptom Management Vol. 39 No. 1 January 2010 doi 10.1016/j.jpainsymman.2009.06.007  PEDIATRIC – Anghelescu D, Hamilton H, Faughnan et al. Pediatric Palliative Sedation Therapy with Propofol: Recommendations Based on Experience in Children with Terminal Cancer. Journal of Palliative Medicine 2012 15(10): 1082-1090

31. Questions Thoughts Comments