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At-home palliative sedation for end-of-life cancer patients

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At-home palliative sedation for end-of-life cancer patients

Alberto Alonso-Babarro, Maria Varela-Cerdeira, Isabel Torres-Vigil, Ricardo Rodríguez-Barrientos and Eduardo Bruera
Palliat Med 2010 24: 486 originally published online 3 February 2010
DOI: 10.1177/0269216309359996

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Original Article
Palliative Medicine
24(5) 486–492
At-home palliative sedation ! The Author(s) 2010
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DOI: 10.1177/0269216309359996
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Alberto Alonso-Babarro Palliative Care Unit, Hospital Universitario La Paz, Madrid, Spain
Maria Varela-Cerdeira Palliative Home Care Team, Madrid, Spain
Isabel Torres-Vigil Department of Health Disparities Research, Center for Research on Minority Health, The University of Texas M. D. Anderson
Cancer Center, Houston, Texas, USA
Ricardo Rodrı́guez-Barrientos Técnico Unidad Docente, Madrid, Spain
Eduardo Bruera Department of Palliative Care and Rehabilitation Medicine, The University of Texas M. D. Anderson Cancer Center
Houston, Texas, USA

Abstract
Using a decision-making and treatment checklist developed to facilitate the at-home palliative sedation process, we
assessed the incidence and efficacy of palliative sedation for end-of-life cancer patients with intractable symptoms who
died at home. We retrospectively reviewed the medical records of 370 patients who were followed by a palliative home
care team. Twenty-nine of 245 patients (12%) who died at home had received palliative sedation. The mean age of the
patients who received palliative sedation was 58  17 years, and the mean age of the patients who did not receive
palliative sedation was 69  15 years (p ¼ 0.002). No other differences were detected between patients who did or did
not receive palliative sedation. The most common indications for palliative sedation were delirium (62%) and dyspnea
(14%). Twenty-seven patients (93%) received midazolam for palliative sedation (final mean dose of 74 mg), and two (7%)
received levomepromazine (final mean dose of 125 mg). The mean time between palliative sedation initiation and time of
death was 2.6 days. In 13 of the cases (45%), the palliative sedation decision was made with the patient and his or her
family members, and in another 13 patients (45%), the palliative sedation decision was made only with the patient’s family
members. We concluded that palliative sedation may be used safely and efficaciously to treat dying cancer patients with
refractory symptoms at home.

Keywords
Palliative sedation, midazolam, end-of-life care, palliative care, terminal care, home care

Introduction PS in the home setting7–12 have found great variation

Palliative sedation (PS) is the use of specific sedatives to
relieve intolerable suffering from refractory symptoms
by reducing a patient’s level of consciousness. To justify
continuous and deep PS, the patient’s disease should be
irreversible and advanced, with death expected within
hours to days.1,2 Although PS is an ethically and legally
well-accepted intervention,1–5 the frequency of PS use
has been reported to range from only 3% to 52% in
terminally ill patients.6 This wide range may reflect var-
iations in the definitions of sedation and the differences
in the settings in which terminally ill patients are treated.
Currently, little is known about the use of PS in
community settings, and the few studies published on
in PS practices. Thus, the incidence of PS in the home
setting, the populations receiving it, and the methods of
providing it have not been well defined, although
Rietjens et al. recently suggested that the use of PS in
the home setting has increased over the past few years.13
One of the concerns about PS – and about at-home
PS in particular – is the belief that PS should not become
a substitute for the meticulous assessment and intensive
treatment of patients’ physical symptoms and psycho-
logic or spiritual distress. Establishing PS standards for
the home setting could help address these concerns and
guide clinicians in their decision-making process. In this
retrospective study, we sought to investigate the

Corresponding author:
Alberto Alonso-Babarro, Unidad de Cuidados Paliativos, Hospital La Paz, Po Castellana 26, 28046 Madrid, Spain. Email: albertoalonsob@gmail.com

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A Alonso-Babarro et al.
frequency of PS use in cancer patients who had died at
home, the reasons for PS use in these patients, the
decision-making process for choosing PS, and the
drugs administered to achieve PS.
Patients and methods
Palliative home care team and study location
The study was conducted in Madrid by a palliative
home care team (PHCT), which was established in
1998 and provided care in one of the regional health
care areas of Madrid. The team is composed of two
physicians, two nurses, a nurse assistant, a part-time
social worker, and an administrative clerk. The
PHCT conducts regular follow-up of patients referred
by acute care hospitals, medical oncologists or family
physicians. Patients are referred after being diagnosed
with a progressive, incurable disease and a high symp-
tom burden. The PHCT mostly provides care to termi-
nally ill cancer patients, and only terminally ill cancer
patients were included in this study.
At-home palliative sedation checklist and protocol
To ensure appropriate use of PS, the PHCT created a
checklist based on a review of the literature4,14,15 and
expert opinions (Table 1). The checklist is intended to
guide the decision-making process by providing sugges-
tions for discontinuing interventions that are not
focused on comfort care and a detailed protocol for
administering and monitoring PS. We used the check-
list prospectively, on all patients that were seen by
PHCT during the study period.
Symptoms were identified as refractory only after
standard available symptom treatments had failed.
For instance, a patient’s delirium was identified as
refractory only after it was determined not to be due
to treatable causes (e.g. dehydration) and unsuccessful
treatment with neuroleptic agents. In patients with dys-
pnea, treatment with opioids was first attempted prior
to classifying the symptom as refractory. In cases of
anxiety/psychoexistential suffering, a psychologist
with expertise in palliative care was consulted before
the decision to begin PS was made.
Regarding treatment, our PS checklist recommends
beginning PS with midazolam followed by levomepro-
mazine if midazolam proves ineffective. If both mida-
zolam and levomepromazine fail, phenobarbital is the
next option to consider. All medications should be
administered subcutaneously. Oral or transdermal
opioids were switched to subcutaneous morphine at
equivalent analgesic doses. Opioid doses were modified
only in cases of uncontrolled pain. All drugs that
needed to be continued during PS were switched to
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487
subcutaneous administration at equivalent doses.
Enteral or parenteral nutrition was withdrawn. We
determined whether to use parenteral hydration on
the basis of the patient’s clinical condition. If indicated,
hydration was administered subcutaneously at a maxi-
mum dose of 1000 ml/day normal saline.
The patients’ level of sedation was monitored twice a
day by physicians or nurses using the Ramsay sedation
scale.16 The goal of sedation was to control symptoms,
not to achieve a determined level of consciousness.
During PS, physicians were on call until 9 pm; if
needed, family members could call emergency ambu-
lance services after 9 pm. Patients could be transferred
to the hospital at any time if required by their clinical
condition or if requested by relatives.
Study design and data collection
We retrospectively reviewed the medical charts of all
patients who received at-home care from the PHCT
between January 2002 and December 2004. All cancer
patients older than 18 years of age who had been visited
at least once by the team were included in the study. We
narrowed the study group down to those who died at
home. We collected data on the patients’ demographic
and clinical characteristics. We also recorded the PHCT’s
responses on the PS checklist for each patient. We stud-
ied the need for increasing doses of midazolam during
PS and the association between the need for increasing
doses of midazolam and younger age, pre-exposure to
benzodiazepines and length of sedation. Finally, we col-
lected information regarding the patients’ awareness of
their terminal condition and how the decision was made
to begin PS. This study was approved by the Institu-
tional Review Board of the Primary Care Program.
Statistical analyses
We investigated the associations between the use of PS
and the patients’ demographic and clinical characteris-
tics. First, we calculated descriptive statistics (frequen-
cies, percentages, means, medians, ranges and standard
deviations) for all variables of interest. We then exam-
ined the variables of interest for normality of distribu-
tion. We used analyses of variance, t tests, and
chi-squared tests for group comparisons. For all anal-
yses, significance was set at p < 0.05 (two tailed). All
data were analysed using SPSS version 11.0 software
for Windows (SPSS Inc., Chicago, IL, USA).
Results
The PHCT followed 370 cancer patients between
January 2002 and December 2004, and the mean dura-
tion of palliative care was 63.9 days (range, 6–248 days),
488 Palliative Medicine 24(5)

Table 1. Palliative sedation at home checklist

Part A. Clinical Assessment of Patient and Preparation for Palliative Sedation

1. Criteria for patient selection:
( ) Irreversible advanced disease
( ) Death expected within hours, days, or a few weeks
( ) Confirm that symptoms are refractory to other therapies that are acceptable to the patient and have a reasonable potential to
achieve comfort goals
( ) Describe main symptom that indicates need for palliative sedation: __________________
2. Decision-making process and informed consent:
( ) Confirm consensus between PHCT nurse and physician
( ) Confirm consensus between primary care team and PHCT
( ) Patient informed and involved in decision-making process
( ) Family informed and involved in decision-making process
3. Discontinue interventions not focused on comfort
( ) Discontinue routine laboratory and imaging studies and other nonessential diagnostic tests
( ) Review medications; limit to those needed for comfort; provide medications primarily by subcutaneous injection (either bolus or
continuous infusion)
( ) Discontinue the use of nutrition
( ) Decide the use or withdrawal of hydration
( ) Provide comfort care
Part B. Treatment
1. Provide sedatives; titrate to achieve symptom control, and frequently evaluate
( ) Start sedation with midazolam:
( ) Induction dose of midazolam 5.0–7.5 mg SQ; continue with 5.0–7.5 mg every 4 hours or 30–45 mg SQ continuous infusion, if
effective
( ) If not effective, increase previously used dose by 50% until symptom control is achieved; maximum daily dose: 200 mg/day
( ) If midazolam is not effective, consider referring patient to hospital or initiating levomepromazine
( ) Induction dose levomepromazine12.5–25.0 mg SQ; continue with 12.5–25.0 mg every 6 hours or 50–100 mg SQ continuous
infusion, if effective
( ) If not effective, increase previously used dose by 50% until symptom control is achieved; maximum daily dose: 300 mg/day
( ) If levomepromazine is not effective, consider referring patient to hospital or initiating phenobarbital
( ) Induction dose Phenobarbital 12.5–25.0 mg SQ; continue with 12.5–25.0 mg every 6 hours or 50–100 mg SQ continuous infusion,
if effective
( ) If phenobarbital is not effective, increase previously used dose by 50% until symptom control is achieved; maximum daily dose:
1600 mg/day
( ) If none of the sedatives are effective, refer patient to hospital
2. Monitor both patient and relatives
( ) Check every 12 hours by phone and every 24 hours during home visit:
( ) Symptom control
( ) Level of consciousness using Ramsay sedation scale
( ) Family distress
PHCT: palliative home care team, SQ: subcutaneous route.

with a median of 48 days. A total of 245 patients (66%)
died at home, and 125 patients (34%) died at a hospital
or hospice.
Among the patients who died at home, 29 (12%)
received PS. Table 2 summarizes the characteristics of
these patients compared with the 216 patients who died
at home but did not receive PS. The mean age of the pati-
ents who received PS was significantly lower (58 years)
than that of the patients who did not receive PS (69
years; p ¼ 0.002). Patients who received PS were more
likely to have been aware of their prognosis than those
who did not receive PS (86% versus 62%; p ¼ 0.013). No
other differences were detected between the two groups.
Table 3 summarizes the indications for PS, the drugs
and doses used, and the mean duration of PS. The most
common indications for PS were delirium (18 patients;
62%) and dyspnea (4 patients; 14%). Midazolam was
sufficient for achieving PS in 27 patients (93%), and only
two patients (7%) required levomepromazine. The mean
dosage in the last 24 hours of the patients’ lives was
73.88 mg for midazolam and 125 mg for levomepromazine.
We found no significant differences between the need for
increasing doses of midazolam and younger age,
pre-exposure to benzodiazepines and length of sedation.
The mean duration of PS (from initiation until death)
was 2.6 days (range, 1–10 days). We found no significant

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A Alonso-Babarro et al. 489

Table 2. Characteristics of patients who did or did not receive palliative sedation and who died at home

Patients who did not Patients who

receive PS (n ¼ 216) received PS (n ¼ 29)

n % n % p-value

Mean age  SD 68.6  15.1 y – 57.6  16.5 y – 0.002

Sex 0.284
Men 120 56 13 45
Women 96 44 16 55
Primary tumour
Lung 30 14 5 17 0.066
Gastrointestinal 78 36 9 31 0.078
Genitourinary 26 12 1 3 0.054
Breast 20 9 3 10 0.965
Central nervous system 17 8 1 3 0.076
Unknown origin 14 7 2 7 0.975
Haematological 8 4 – – –
Head and neck 8 4 3 10 0.052
Other 15 7 5 17 0.056
Mean survival duration after 63.3  88.1 days – 63.9  59.95 days – 0.963
PHCT initiated care
Awareness of the prognosis 132 62 25 86 0.013
PHCT: palliative home care team, PS: palliative sedation, SD: standard deviation.

Table 3. Clinical indications for receiving palliative sedation

Mean duration Mean dose on

Indications for Number of of PS  SD last day of PS  SD
palliative sedation patients (%) (range), days Drug used (range), mg

Delirium 18 (62) 2.5  1.8 (1–7) Midazolam (n ¼ 17) 58  28 (30–120)

Levomepromazine 150
(n ¼ 1)
Dyspnea 4 (14) 2.5  0.6 (2–3) Midazolam 97.5  15 (90–120)
Nausea/vomiting/bowel obstruction 2 (7) 1 (1–1) Midazolam 75  21 (60–90)
Seizures 2 (7) 3.5  2.1 (2–5) Midazolam 60  42 (30–90)
Anxiety/psychoexistential suffering 2 (7) 5.5  6.4 (1–10) Midazolam 75  21 (60–90)
Pain 1 (3) 3 (3–3) Levomepromazine 100
PHCT: palliative home care team, PS: palliative sedation, SD: standard deviation.

differences in the mean doses required on the last day, or
the mean number of days of PS between patients with
different indications for PS. In all patients, symptom
control was achieved in a few hours, and the level of
consciousness was rated as 5 or greater using the
Ramsay scale within 24 hours after PS initiation. Par-
enteral hydration was used in only two patients. We did
not register any emergency calls during the PS process.
Eventually, all patients who started PS died at home.
In 13 patients (45%), the patient and their family
members were involved in the decision to use PS. Six
of these patients were directly involved in the
decision-making process immediately prior to starting
PS; in the other seven patients, their wishes regarding
PS had been documented in their medical charts. In
another 13 patients (45%), only the patients’ family
members were involved in the PS decision-making pro-
cess. Documentation about the decision-making pro-
cess could not be located in 3 cases (10%).
Discussion
To our knowledge, this is one of first studies addressing
PS in the home setting to demonstrate the safety and

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490
efficacy of at-home PS administered by a PHCT.
Indeed, all patients who started PS died at home. The
checklist used in our study may also provide other
researchers and clinicians with an easy-to-use decision
aid and treatment tool to facilitate the PS process.
Additional multicenter prospective home-based studies
are needed to replicate our findings.
In our study, PS was used in 12% of the patients
who died at home. In the first known study of PS in the
home setting, Ventafridda et al.7 reported the use of PS
in 63 of 120 patients (53%) who died at home while
being assisted by a PHCT in Milan. In another study of
at-home PS, Bulli et al.10 reported on 1075 patients who
were followed by PHCTs in the Florence area. In that
study, PS was used in 136 patients (13%), but the
authors did not report the clinical indications for
PS use. In addition, 20% of patients who received
PS did not die at home. Porzio et al.11 conducted an
observational study in L’Aquila (Italy) to retrospec-
tively evaluate the frequency and efficacy of PS
in patients followed at home by a PHCT. They
reviewed the medical charts of 121 patients and found
that PS was used in 16 of 44 patients who died at
home (36%). Other than in the study by Ventafridda
et al.7 all of these studies (including ours) involved
PHCTs working in coordination with a hospital-based
palliative care unit. This may have resulted in a reduced
need for at-home PS since home-based patients
could be referred to the hospital as needed for
symptom control.
The incidence of PS use in our study was signifi-
cantly lower than the 20–50% PS rate reported by
other hospital-based palliative care units.17–21 This dif-
ference could be explained in two ways. First, hospita-
lized patients tend to have a greater symptom burden
than those who remain at home and, consequently, may
require PS more frequently. Second, because patients
who are at home are probably less likely to be agitated
as a result of delirium than patients in the hospital set-
ting, there may be a reduced need for delirium-
indicated PS at home. Nevertheless, as reported in
other studies of PS,1,6 the most common indication
for PS in our study was delirium-related agitation
that was non-responsive to treatment with haloperidol
or other antipsychotic medications.
We found no significant differences in the sex, pri-
mary tumour, or duration of palliative care between the
patients who did and did not receive PS. However,
patients who received PS were younger than those
who did not receive PS (mean, 58 years versus 69
years), which is similar to what has been reported by
others.19,20 It has been hypothesized that managing
symptoms in younger adults is more complex and
requires more aggressive treatment than in older
adults. More studies are needed to test this hypothesis
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Palliative Medicine 24(5)
and further elucidate the reasons for the higher fre-
quency of PS in younger patients.
There has been considerable controversy surround-
ing the use of PS in response to psychoexistential suf-
fering. In a review of the PS literature, Claessens et al.6
found that 27% of the studies noted psychoexistential
suffering as a reason for PS. This indication for PS has
been noted in several Latin American and Asian stu-
dies.8,9,12,22,23 A multicentre international study on PS17
found that a higher percentage of patients in Spain who
received PS did so for psychoexistential distress com-
pared with patients in other countries. Fainsinger
et al.24 later conducted a study that included patients
from two palliative care units in Madrid, Spain, and
Edmonton, Canada, to explore the cultural differences
in the perceived values of clear cognition and disclosure
of information in terminally ill cancer patients. In
Edmonton, the patients and their families placed a
higher value on clear thinking, changes in medications
causing drowsiness/confusion, and full disclosure. In
addition, these patients and their families agreed on
the way of thinking almost 100% of the time, while
in Madrid agreement between the patients and their
families was roughly 50%. The authors concluded
that the lack of concurrence between patients and
families may complicate the PHCT’s communication
with patients and families, as well as the management
of patients with intractable symptoms. Consequently,
this may have led to the higher rates of psychoexisten-
tial suffering-indicated PS in Spain. In contrast, the fre-
quency of psychoexistential suffering-indicated PS in
our study was low. We found a higher percentage of
patients who were informed of their diagnosis and
prognosis than in a previously reported study in
Spain;25 this finding may have resulted in a reduced
need for PS for psychoexistential distress. More
research is needed to better understand the reasons
for these differences across studies.
Published recommendations for clinical practice spe-
cifically state that PS should be discussed with the
patient (if possible) and/or his or her family.1,2
However, the reported degree of involvement in the
decision-making process and disclosure of information
to patients and families vary considerably among stu-
dies. For example, Morita et al.22 reported that only
7% of the patients who received PS in a hospice setting
were informed that PS may result in a shortened life
expectancy and somnolence. In another study, Chater
et al.26 surveyed experts in the United Kingdom about
the degree of involvement of the patient and his or her
family during the decision-making process for PS.
According to the palliative care experts, 50% of
patients and 69% of families had major involvement
in the decision-making process. Rietjens et al.20
reported that 60% of patients and 89% of the relatives
A Alonso-Babarro et al.
were involved in the discussions about PS in a palliative
care unit of a cancer hospital. In contrast, Mercadante
et al.19 found that family members of all patients with
PS were involved in the decision-making process,
although nothing was reported regarding the patients’
roles. Palliative care teams should encourage both
patients and their families to participate in the
decision-making process for PS. Incorporating the
patient’s wishes regarding PS in advanced directives
or discussing these issues with patients prior to the
final days of their lives may help avoid unnecessary
patient and caregiver stress and burden.
Midazolam was used to induce and maintain seda-
tion in 93% of the patients in our study. In a prospec-
tive cohort study conducted in a palliative care unit,
Mercadante et al.19 observed that increasing doses of
midazolam were required close to death to maintain
adequate symptom control. This need to administer
increasing doses of midazolam may indicate that the
patient has developed a tolerance to midazolam.
However, in our study, we did not find a significant
association between the need for increasing doses of
midazolam and younger age, pre-exposure to benzodia-
zepines, or length of sedation. We found that two
patients needed to have their PS medication changed
to levomepromazine, which was effective in both
patients.
Of note, we found no significant differences in the
patients’ survival durations after initiation of palliative
care between the patients who received at-home PS and
those who did not receive PS. This was similar to the
results reported by others,6–11,13,17–23 suggesting that PS
does not hasten death if carefully administered by pal-
liative care specialists.
Our study had several possible limitations. First,
retrospective studies are inherently based on limited
available clinical data. Thus, bias may have resulted
if the patients with data missing in their medical
charts differed from the patients with complete
information. Second, this was a single-institution
study, and institutions can vary greatly in their PS prac-
tice patterns. However, the use of the standardized
checklist minimized the potential for bias during data
collection and assured that the PS protocol was uni-
formly implemented. Finally, our small sample size
may have lacked sufficient power to detect important
differences.
We concluded that PS may be used safely and effi-
caciously to treat dying cancer patients with refractory
symptoms at home. As suggested in other studies,11,12
PS should be one of the basic services offered by
PHCTs. In some cases, PS may be the only way to
achieve a peaceful death at home, thus ensuring that
the wishes of the patients and their caregivers are
respected.
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491
Acknowledgments
The authors wish to acknowledge Alyson Todd, from MD
Anderson’s Department of Scientific Publications, for her edi-
torial contributions, which enhanced the clarity of this
manuscript.
Conflict of Interest Disclosures
Dr Eduardo Bruera is supported in part by the National
Institutes of Health Grant numbers RO1NR010162-01A,
RO1CA122229-01, and RO1CA124481-01. Dr Torres-Vigil
is supported in part by the National Institutes of Health
grant number 3R01CA122292-03S1.
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