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					Nova Scotia Hospice Palliative Care Association Annual
                  Conference 2011



PALLIATIVE SEDATION
           Myth, Mercy or
           Euphemism?

            Dr Nigel Sykes
       St Christopher's Hospice
                London
     A Confusion of Terms
uTerms:
  vPalliative sedation
  vTerminal sedation
  vEarly terminal sedation
  vPalliative sedation therapy
  vPrimary sedation
  vSecondary sedation
  vProportionate sedation
  vControlled sedation for intractable distress
   in the dying
  vSudden sedation
  vContinuous deep sedation
A Manifold Definition of Palliative
            Sedation
                (Adapted from Jones, 2011)

Palliative Sedation is the use of sedatives that is either
   continuous or intermittent; deep or mild; the primary or
   secondary pharmacological effect; proportionate or
   disproportionate to ‘refractory symptoms’ ; which
   include or do not include ‘existential distress’; in a
   patient who is or is not imminently dying; at the request
   or not of the patient; who intends or does not intend to
   be unconscious until death; with the doctor also
   intending this or not; withholding or not withholding
   nutrition and hydration; with or without an advance
   refusal; such that this protocol does or does not actually
   hasten death; and is intended or is not intended to do
   so by the patient; and is intended or is not intended to
   do so by the patient

   This yields 4,782,969 possible definitions of
                 Palliative Sedation…
Is the likely clinical effect of this
            Definition…
uPalliative Sedation is the use of
 sedatives that is intermittent;
 mild; proportionate to ‘refractory
 symptoms’ ; in a patient who is
 imminently dying; not
 withholding nutrition and
 hydration
 …the same as the likely clinical
    effect of this Definition?
uPalliative Sedation is the use of
 sedatives that is continuous, deep,
 disproportionate to ‘refractory
 symptoms’ ; in a patient who is not
 imminently dying but is intended
 to be unconscious until death;
 withholding nutrition and hydration

   A Euphemism for Euthanasia?
   A Confusion of Purposes
Sedation can mean:
uThe giving of sedatives for specific
 symptom control, e.g.
  vSeizures
  vDelirium in the absence of correctable
   factors
uA treatment for insomnia
uThe attempt to make a patient unaware
 of a intractable symptom by reducing
 their conscious level

  An expert survey achieved only 40%
   agreement with a single definition of
           sedation (Chater, 1998)
      What is an intractable
           symptom?
An "intractable" symptom is one:
uthat does not respond to available
 treatment or
ufor which the treatment is unacceptable to
 the patient because of:
  vinsufficiently rapid action or
   vexcessive side effects (Cherny and Portenoy, 1994)

     Sedation is used significantly more often by
      doctors who predict that a symptom will be
     intractable than by those who actually try all
               the treatments (Morita, 2004)
  Reasons for sedation
Multicentre study of 387 terminally ill
 patients
uHaemorrhage                            0.8%
uDistress                               1.8%
uPain                                   1.8%
uNausea and vomiting            2.3%
uBreathlessness                         6.5%
uDelirium                               15.2%
                           (Fainsinger et al., 2000)
  How often is sedation used in
        Palliative Care?
 Reports of the proportion of patients
  who require sedation in the closing
        days of life vary widely:
  v1% (Fainsinger, 1998)
  v88% (Turner et al., 1996)
uThis situation is not getting any better:
  vProspective study of the use of all depths and
   lengths of sedation in eight palliative care units
   showed a rate of 7.5%
                                 (Claessens et al, 2011)
  vRetrospective study from one palliative care
   unit of the use specifically of continuous deep
   sedation showed a rate of 43%
                                 (Rietjens et al., 2008)
  Sedation in Palliative Care
uThe use of sedative drugs has always been
 a part of Palliative Care at the end of life:
  vFor mental distress (but only as an adjunct to
   the giving of properly attentive time)
                                (Saunders, 1960)
  vFor anxiety or agitated confusion
                                (Saunders, 1965)
  vOpiates should not be used as sedatives
                                (Saunders, 1958)
 “It should hardly ever be necessary to use
    the very heavy sedation that completely
       smothers the patient’s personality,
 although many who see these patients only
      occasionally do not believe that it is
       possible to avoid this” (Saunders, 1967)
    “Very heavy sedation that
     completely smothers the
       patient’s personality”
uThe crux of ethical and clinical
 concern seems to be whether
 sedative use:
  vObliterates the patient’s personality
   and destroys the possibility of further
   emotional and spiritual development
  vKills the patient
     Sedatives can do both these
                 things
  Sedation for intractable
        symptoms
The paramount moral obligation is to
 relieve suffering
u“A doctor who leaves a patient to suffer
 intolerably is morally more
 reprehensible than the doctor who
 performs euthanasia”
                              Twycross, 1996


                 Mercy
     Principle of Double Effect
       (The Get-out Clause)
u A harmful effect of treatment, even resulting in
  death, is permissible providing that it:
   v was not intended and
   v arises as a side effect of a beneficial action and
   v the harmful effect was not the means of achieving the
     beneficial effect
u But if we need to invoke the Principle of Double
  Effect does this suggest we are routinely
  shortening patients’ lives by sedation?


                   Truth or Myth?
Classification of end of life care
             sedation
         (Broeckaert, 2000)

Mild        Intermittent   Acute




Deep        Continuous     Non-acute
  Classification of end of life care
               sedation
       (Morita, Tsuneto and Shima, 2001)

Mild    Intermittent   Primary     Pain            No organ
                                                   failure




Deep    Continuous     Secondary   Psychological   Organ
                                   distress        failure
      How is depth of sedation
             assessed?
u Glasgow Coma Scale (Teasdale and Jennett, 1974)
u Communication Capacity Scale (Morita et al., 2001)
u Consciousness Scale for Palliative Care
                                          (Goncalves et al.,2008)
u Physicians’ unsubstantiated report

u Assessment of the deepest sedation requires
  infliction of pain:
   v Supra-orbital pressure (GCS)
   v Pain (unspecified method) or change in position (CCS)
   v Trapezius pinch (CSPC)
u How willing are palliative care staff to carry out
  these assessments routinely?
         Depth of Sedation
uIt has been suggested that the depth of
 sedation tends to increase as death
 approaches
  v45% of patients originally given ‘mild’
   sedation had ‘deep continuous’ sedation by
   two days before death (Claessens et al., 2011)
     t But this is based on only 9 patients and it is not
       clear how the sedative doses changed in the
       interim
uHow different is this from the natural
 trajectory of dying?
  v50% of Palliative Care not receiving
   sedatives are unable to manage complex
   communication five days before death
                              (Morita et al., 2003)
      What is in the Name?
uThe root of the word sedation is the
 Latin sedatio meaning ‘soothing’ or
 ‘allaying’
uThe clinical purpose of sedative drugs in
 palliation is the reduction of irritability
 or agitation, i.e. the relief of distress
uSleep is not the intention but may occur
 either:
   vif a high enough sedative dose is required
    to relieve the distress or
   vIf a tired, ill patient is enabled to be
    comfortable and relaxed
            Continuousness
u Sedation is a response to a symptom
u Continuous symptoms need continuous relief
   v See use of regular morphine in chronic pain for
     details
u 30% of patients receiving sedatives do so only
  on an ‘as required’ basis
   v Median 2.5mg midazolam on a median of 2
     occasions (Dunn et al., 2008)
u Liverpool Care Pathway Guidance suggests use
  of a continuous subcutaneous infusion if two
  or more ‘as required’ doses of sedative have
  been given in 24h (NCPC, 2006)
   v So ‘as required’ rapidly becomes ‘continuous’
  Continuous sedative administration is neither
           rare nor necessarily sinister
             Proportionality
u There is a growing consensus that the essence
  of sedative use in Palliative Care is
  proportionality
      t Morita, Tsuneto and Shima, 2002
      t De Graeff and Dean, 2007
      t Brockaert and Claessens, 2009
      t Cherny and Radbruch, 2009
      t Hasselaar, Verhagen and Vissers, 2009
      t Quill et al., 2009
u But not everywhere. The Dutch National
  Guideline on Palliative Sedation speaks of
  proportionality but assumes:
   v The aim is to reduce consciousness
   v The patient should be within 2 weeks of dying
   v Administration of fluids should be stopped
   v A doctor should be present at initiation of sedation
                                       (KNMG 2005/2009)
Proportionate Responses are key
   to Palliative Care Practice
uThe mode of use of sedatives is
 analogous to that of other symptom
 control measures, such as opioids for
 pain:
  vA low initial dose is titrated higher against
   the response until distress is relieved, i.e.
   the dose used is proportional to severity of
   distress
  vRelief of distress is the end-point, not a
   particular level of consciousness
What is a Proportionate Dose of
           Sedative?
u Midazolam is the most commonly used sedative in
  Palliative Care (Sykes and Thorns, 2003a)

u Mean midazolam doses reported range from 22 to
  70mg/24h (Mercadante et al., 2009)
   v But individually as high as 240mg/24h


u In our study of 238 patients:
   v Overall mean midazolam dose was 25.7 mg/24 h
   v Mean midazolam dose for patients receiving sedation
     throughout the last week of life
     was 54.5 mg/24 h (Sykes and Thorns, 2003b)
Effect of Sedation on Palliative
    Care patients’ Survival
 Study               With        Without
                     sedation    sedation
 Stone, 1997         18.6 days   19.1 days
 (UK)
 Ventafridda, 1990   25 days     23 days
 (Italy)
 Chiu, 2001          28.5 days   24.7 days
 (Taiwan)
 Sykes, 2003b        38.6 days   14.2 days
 (UK)
 Kohara, 2005        28.9 days   39.5 days
 (Japan)
      Duration of Sedation

uMean duration of sedation
 estimated to be 2.5 days (range
 1.3-3.9)
  vBased on ten studies, totalling
   1,900 patients (Porta Sales, 2001 updated)
 Suggests that sedation is generally a
   response to symptoms associated
        with the onset of dying
           Midazolam use at St
              Christopher’s
In a random recent month:
u 55 patients died
u 51 (93%) had at least one dose
u 35 (64%) had a continuous s.c. infusion
u 14 (40%) of infusions started within 48h of death
u 14 (40%) of infusions started 3 to 7 days before
  death
   v All had either already stopped eating or ate until 3 to 5
     days before death
u 7 (20%) infusions lasted between one week and
  one month
   v Of these patients five continued to eat until 3 to 5 days
     before death
   v The other two had gastrostomy feeding
        Was our sedation rate 93% or zero?
         Case History 1

  58 year old man with astrocytoma
uGeneral condition noted to be
 deteriorating
uDeveloped an acute onset of violent
 agitation and paranoia
uMidazolam 20mg given i.m. stat
 followed by 55mg/24h by s.c.
 infusion
uDied 55 hours later
             Case History 2

   70 year old woman with lung cancer and a
         previous history of schizophrenia
u Admitted because of general deterioration
u Developed delusions and progressive agitation
  unresponsive to haloperidol doses up to 12mg
  per day
u Over 24h she received 125 mg
  levomepromazine and 60 mg midazolam by
  s.c. infusion, but also another 60 mg
  midazolam and 200 mg levomepromazine in
  s.c stat doses for continuing agitation
u At the end of this period her breathing was
  noted to be noisy. 200 mg phenobarbital was
  given s.c. and the patient died 6 h later.
      And yet some will ask:
uIs sedation used to cover up potentially
 remediable delirium?
  v73% of delirium in palliative care is irreversible
  vLife expectancy of patients with irreversible
   delirium is under 17 days (Leonard et al., 2008)
uWhat about provision of hydration and
 nutrition?
  vThis is a separate decision, but the great
   majority of patients who receive sedatives
   already have minimal oral intake
uWhat about sedation for existential
 distress?
  vDoes not correlate with physical deterioration
  Use of sedatives in existential or
       psychological distress

u Hard to tell if such distress is really intractable
   v Level of distress can be variable and idiosyncratic
   v Standard treatments have low morbidity
   v Intractability can only be decided by a
     multiprofessional clinical team skilled in psychological
     care who know both patient and family and have made
     repeated assessments
   v Team access to psychiatry, chaplaincy and ethics is
     required                    (Cherny and Radbruch, 2009)
u Some sedative use may be helpful, as may
  respite sedation to provide periods of ‘time out’
u But the induction of sleep for extended periods
  should be a truly exceptional occurrence
               Conclusions
u ‘Sedation’ continues to mean different things to
  different people
u In specialist palliative care units use of
  sedatives in the last days of life is not
  associated with shortened survival overall
u Most use of sedatives is for the management
  of restlessness and confusion occurring as part
  of the process of dying
u Impaired consciousness is common at the end
  of life with or without sedatives
u The aim of sedative use is to relieve distress,
  not to induce sleep
u The key to ethical use of sedatives is
  proportionality, whatever the indication
   If Palliative Sedation is
   approached properly…
uIt will be an act of Mercy for our
 patients whose distress cannot be
 relieved by other means
uIt will be a Myth that it shortens
 patients’ lives
              And so
uIt will not be a Euphemism for
 Euthanasia

				
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