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Expert-approved best practice recommendations on the use of sedative drugs and intentional sedation in specialist palliative care (SedPall)



The use of sedative drugs and intentional sedation in end-of-life care is associated with clinical, ethical and legal challenges. In view of these and of the issue’s great importance to patients undergoing intolerable suffering, we conducted a project titled SedPall (“From anxiolysis to deep continuous sedation – Development of recommendations for sedation in palliative care“) with the purpose of developing best practice recommendations on the use of sedative drugs and intentional sedation in specialist palliative care and obtaining feedback and approval from experts in this area.


Our stepwise approach entailed drafting the recommendations, obtaining expert feedback, conducting a single-round Delphi study, and convening a consensus conference. As an interdisciplinary group, we created a set of best practice recommendations based on previously published guidance and empirical and normative analysis, and drawing on feedback from experts, including patient representatives and of public involvement participants. We set the required agreement rate for approval at the single-round Delphi and the consensus conference at ≥80%.


Ten experts commented on the recommendations’ first draft. The Delphi panel comprised 50 experts and patient and public involvement participants, while 46 participants attended the consensus conference. In total, the participants in these stages of the process approved 66 recommendations, covering the topics “indications”, “intent/purpose [of sedation]”, “decision-making”, “information and consent”, “medication and type of sedation”, “monitoring”, “management of fluids and nutrition”, “continuing other measures”, “support for relatives”, and “team support”. The recommendations include suggestions on terminology and comments on legal issues.


Further research will be required for evaluating the feasibility of the recommendations’ implementation and their effectiveness. The recommendations and the suggested terminology may serve as a resource for healthcare professionals in Germany on the use of sedative drugs and intentional sedation in specialist palliative care and may contribute to discussion on the topic at an international level.

Trial Registration

DRKS00015047 (German Clinical Trials Register)

Peer Review reports


Sedative drugs are widely used for symptom control in palliative care, for purposes including the relief of agitation or anxiety. Due to their ability to induce a sustained reduction in consciousness, their use entails complex ethical, legal and cultural challenges [1]. A reduction in consciousness, while it may be consistent with the patient’s wishes, may lead to an unwanted loss of autonomy and a decreased ability to communicate with healthcare professionals and family members [2]. The current debate in this area largely focuses on what is generally termed “palliative sedation”, defined by the European Association for Palliative Care (EAPC) as “the monitored use of medications intended to induce a state of decreased or absent awareness (unconsciousness) in order to relieve the burden of otherwise intractable suffering in a manner that is ethically acceptable to the patient, family and health-care providers” [3]. The umbrella term “palliative sedation” encompasses various possible practices differing in terms of the depth (light/deep) or the duration of sedation (temporary/continuous). Sedation as a side-effect of medication (secondary sedation) [4], albeit not covered by this definition, unfolds a similar impact on patients’ autonomy and capacity to communicate. The current international literature demonstrates the challenges facing this area of medicine by reporting a variety of indications for “palliative sedation” [3, 5, 6] and the use of a number of different medications and dosages. International guidance exists, but its terminology and content are heterogeneous [2, 7,8,9,10,11]. In Germany, physicians and teams might adhere to the German translation of the EAPC recommendations for clinical practice, the guidelines published by the Comprehensive Cancer Centres in Germany [12], or the recommendations of the German Academy for Ethics in Medicine [13], as far as they are aware of them [14]. The lack of precise and generally accepted terminology and of a consistent framework impedes transparency in describing sedation practices and the evaluation of the associated clinical and ethico-legal challenges [7, 15, 16]. The authors of the present paper have recently suggested the term “intentional sedation” to indicate a deliberate decision to reduce the patient’s consciousness. Intentional sedation is the “result or process of sedating a patient as a means of achieving a previously defined treatment goal”, for example in cases of intolerable and otherwise untreatable suffering [17]. The terminology in this area also distinguishes temporary sedation (the patient is sedated only for a certain period of time) from sedation until death (the patient remains continuously under sedation until she or he dies).

The purpose of this study was to develop and gain consensus on best practice recommendations for the use of sedative drugs in specialist inpatient and home palliative care, spanning the spectrum from symptom control to intentional sedation for the relief of intolerable and otherwise untreatable suffering. Outside the specialist context, other recommendations may apply, due principally to limited availability of resources; such recommendations are not the subject of this study.


Study design

We carried out a multi-stage process that drew up and attained consensus on best practice recommendations on the use of sedative drugs and intentional sedation in specialist palliative care.

We outline the development of the empirical recommendations in accordance with the CREDES Guidance on Conducting and Reporting Delphi Studies in palliative care [18]. We report patient and public involvement throughout the procedure in line with the GRIPP2 reporting checklists [19].

The project

The project, titled “From anxiolysis to deep continuous sedation – Development of recommendations for sedation in palliative care (SedPall)“ (funded by the German Federal Ministry of Education and Research, BMBF 01GY1702A-C) ran from 2017 to 2021. It was conducted by a multidisciplinary consortium comprising experts from the fields of ethics, gerontology, law, nursing science, palliative care/medicine, philosophy, and sociology, from four institutions (Department of Palliative Medicine, LMU University Hospital, LMU Munich; Department of Palliative Medicine, Universitätsklinikum Erlangen; Institute for History and Ethics of Medicine, Interdisciplinary Center of Health Sciences, Martin Luther University Halle-Wittenberg; and Department of Criminal Law, Criminal Procedural Law, Commercial Criminal Law and Medical Criminal Law, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)). Among the previous work by members of the consortium that informed the development of the recommendations were systematic reviews of published guidance on sedation; empirical data on views and clinical practices around the use of sedative drugs in specialist palliative care, collected in cooperating specialist palliative care services (we term these services our “project partners”); and normative considerations on legal and ethical aspects of the issue [7,8,9, 20].

Patient and public involvement (PPI) participants provided continuous support to the project, enabling us to take patients’ and families’ views on board and obtain their advice on aspects of the issue with particular relevance to them. The PPI participants are experts in the sense of individuals with lived experience of situations in which intentional sedation was discussed or used for members of their families who received specialist palliative care in one of the consortium’s university hospitals.

The scientific advisory board to the project consisted of 21 national and international palliative care experts with a background in medicine, nursing, ethics, law, and/or psychology of whom six were non-German speakers. Some of them were seconded to the project from the German Association for Palliative Medicine (DGP).

The recommendations achieved final approval in a single-round Delphi study and a consensus conference (see Fig. 1).

Fig. 1
figure 1

Study design; PPI = patient and public involvement

Our stepwise approach

The drafting and approval of the recommendations comprised four steps:

Step 1: Drafting recommendations

Four sub-projects conducted preparatory work focusing on various aspects of the use of sedatives and intentional sedation at the end of life (see German Clinical Trials Register DRKS00015047). Sub-project 1 (clinical centre) investigated clinical practices around the use of sedative drugs in palliative care units and home care settings, using chart reviews of patient records [21,22,23]. Sub-project 2 (clinical centre) conducted face-to-face interviews and focus groups exploring views held by patients, relatives, and staff on intentional sedation at the end of life [14]. Sub-project 3 (medical ethics) analysed ethical aspects of the issues and refined the terminology [7]. Sub-project 4 (medical law) analysed the legal aspects of the issues. At a joint meeting, consortium members communicated key findings of their sub-projects and defined and discussed overarching themes that occurred across the sub-projects. Sub-projects 1 and 2 drafted recommendations structured by topic, on the basis of systematic reviews of existing guidance on sedation, the empirical data referenced above in the context of previous work, and the terminology developed during the work up to that point [7, 9, 17, 20]. Sub-projects 3 and 4 added an introductory section around terminology (on the interdisciplinary development of terminology in this area, see reference 7) and legal aspects of the issue. Consortium members subsequently held several video calls during which they discussed and amended the draft, and eventually approved its initial version.

Step 2: Expert feedback on initial draft of recommendations

We invited feedback from German-speaking experts from the project’s scientific advisory board with clinical experience in the use of sedative drugs and intentional sedation in palliative care and/or track records of academic work on the topic in medicine, nursing, law, and/or ethics and from project partners. The experts commented on the recommendations’ initial version in general and/or on individual recommendations. The consortium members and the PPI participants discussed this feedback in a videoconference. The group adapted the recommendations in accordance with the feedback; where it rejected one of the proposed recommendations, it documented the reasons for this directly in the draft worked on during the videoconference (live documentation) [24]. The consortium then gave final approval to the revised recommendations.

Step 3: Single-round Delphi study

The next step consisted in a single-round Delphi study, for which we consciously brought together a panel of experts from a range of professional backgrounds. Inclusion criteria were clinical expertise in the use of sedative drugs or research activities in inpatient or home-based palliative care. The panel included all members of the consortium. PPI participants and project partners from the SedPall project also took part. The participants indicated their approval or non-approval of each recommendation (yes/no). Consensus was defined at an agreement rate of ≥ 80% among all participants, on the basis of percentage agreement rates used in previous studies [18, 25].

Step 4: Consensus conference

A consensus conference took place for the purpose of discussing and approving the recommendations that did not achieve consensus in the single-round Delphi (< 80% approval). The Delphi panel took part in the conference. Participants worked together to adapt non-approved recommendations via livedocumentation [24] and approved them via live voting (with a yes or no to approval). We used the Zoom polling feature for live voting.

Ethics committee approval

The overall study was approved by the Local Research Ethics Committes of Friedrich- Alexander-Universität Erlangen-Nürnberg (FAU) (No. 376_16 Bc, 22 December 2016) and Ludwig-Maximilians-Universität München: (No. 18–191, 19 April 2018) and by the appointed data protection officers. Participants provided written informed consent.


Draft recommendations

Initially, the consortium drafted 74 recommendations on the ten predefined themes of “indications”, “intent/purpose [of sedation]”, “decision-making”, “information and consent”, “medication and types of sedation”, “monitoring”, “management of fluids and nutrition”, “continuation of other measures”, “support for relatives”, and “team support”. For each recommendation, the recommendations’ authors indicated whether it applied to inpatient or home care settings or both. The introductory section included information on ethico-legal issues and terminology.

Expert feedback

Ten out of 28 German-speaking advisory board members and project partners provided feedback and comments on the first draft. Nine of these individuals were male; eight were physicians (n = 3 specialists in internal medicine, n = 2 general practitioners, n = 3 anaesthesiologists), one was a medical ethicist and one was a nurse; all had long-standing experience in palliative care. They provided 73 comments in total.

Consortium members, and PPI participants who wished to engage in this process, revised the draft in accordance with the summarised comments at four videoconferences. They adapted eleven recommendations and struck out a further eight, incorporating relevant aspects of some of those removed into other recommendations. A small number of recommendations initially had separate versions for each setting; the working group subsequently merged each of these into one recommendation covering both settings; this was the case primarily for recommendations relating to the decision-making process. The descriptive nature of two recommendations (relating to the impact of sedation on relatives and team members and to raising treatment teams’ awareness of this impact) led to their inclusion in the section detailing the background to the recommendations and not as recommendations in their own right. The group adjusted recommendations on existential suffering and intentional sedation that had been the subject of contentious discussion. A further addition on indications for sedation clarified the point that the patient’s desire for sedation does not constitute an indication for intentional sedation, but should result in an assessment of whether intentional sedation is indicated. The group added a rationale for the recommendation to measure vital signs in special situations to avoid shortening life. A further clarification stated that the team may only inform relatives of planned sedation if this is in accordance with the patient’s wishes.

The 66 recommendations that remained after this process were put to the subsequent single-round Delphi panel. In addition, the consortium revised the introduction and its sections on terminology and legal aspects in light of the experts’ feedback.

Single-round Delphi study

In January 2021, we invited 46 German-speaking experts (including 15 consortium members) and nine PPI participants to take part in a single-round Delphi in the form of an online survey developed for this study, subsequently sending one reminder. A total of 50 individuals (44 experts and 7 patient and public representatives) took part (participation rate: 90.9%). Most participants were aged 50 years or older. Most of the professional participants were physicians and had more than 10 years of experience in patient care (see characteristics of participants in Table 1).

Table 1 Single-round Delphi: participants’ characteristics (n = 50)

Of 66 recommendations, two did not achieve ≥ 80% consensus. Fifty-two recommendations attained an approval rate of ≥ 90%.

Consensus conference

Forty-six participants attended the online consensus conference (consortium members: n = 12, scientific advisory board members: n = 9, experts from German Association for Palliative Medicine: n = 3, patient and public representatives: n = 5, project partners from inpatient and home care settings: n = 17), which took place in February 2021. The conference achieved consensus on two remaining recommendations after a shared process of adaptation by the consensus conference participants. Both remaining recommendations thus attained the necessary approval rate of ≥ 80% in the live voting.

The total of 66 recommendations finally approved cover ten themes, as shown in Table 2.

Table 2 Approved recommendations

Table 2: Recommendations approved by the end of the process; Legend: SIPC = specialist inpatient palliative care; SPHC = specialist palliative home care. A professional translation was made of the original recommendations, definitions and accompanying text; this translation was revised and adapted to ensure internal consistency with the German version within the SedPall consortium. RASS-PALL according to Bush (2014) [26].


We disseminated the project’s results via a public closing conference, held online in April 2021, at which the consortium gave a presentation of the sub-projects’ key findings and shared excerpts from the recommendations. The 115 attendees comprised consortium members, representatives of project partners, scientific advisory board members and members of the public. Publication took place in print form (in German) and online (German and English) on the website of the German Association for Palliative Medicine (DGP) in the interests of providing open access to the recommendations and to raise awareness of them among those interested in the issue, including institutions and organisations providing palliative care [27, 28].


Key results

This paper outlines the process of drawing up recommendations for the use of sedative drugs and intentional sedation in specialised palliative care, covering the spectrum of purposes from symptom control to deep continuous sedation and taking clinical, ethical and legal issues into account. Previously published evidence in this area could offer little guidance to the consortium due to the heterogeneity characterising definitions of key terms in much of this work [7, 15, 16]. We were unable to draw on the recently published preprint of the updated EAPC framework on palliative sedation, as it was not yet available during our work [29]. Preparatory normative and empirical analysis and the analysis of previously published guidance informed the development of the recommendations, which interdisciplinary experts with a clinical background in specialist palliative care and research, alongside PPI participants, subsequently approved [27]. Although developed for the German context, the recommendations could serve as an example on which other countries and healthcare systems might draw, with appropriate adaptations to the relevant national legal and clinical frameworks.

One major challenge in the use of sedative drugs at the end of life is the distinction between therapeutic administration of drugs of which a reduction in consciousness is a side effect, or secondary drug reactions, and intentional sedation [30,31,32]. Our recommendations seek to meet this challenge by carefully evaluating the nature and impact of any reduction in consciousness affecting the individual patient. If medication may have caused the reduction in consciousness, those treating the patient should consider adjusting the medication. Alternatively, it may be necessary to take a decision on whether intentional sedation is indicated, where distressing symptoms remain intolerable to the patient despite all proportionate measures to relieve them.

It is our hope that the recommendations will provide the best possible support to palliative care professionals in treating and caring for their patients in accordance with the law and in line with the current state of research. The recommendations should increase professionals’ self-confidence in the use of sedative drugs and support the process of multiprofessional team decision-making. It is our hope that they will promote standardisation in this area without limiting individualised care for patients [33]. Future research should seek to establish the feasibility of the recommendations’ implementation in specialist palliative care settings and the extent to which they improve professionals’ confidence in this area and the quality of care.

Intentional sedation and generalist palliative care

The recommendations are intended for specialist palliative care settings. This restriction may appear to exclude from their applicability the majority of patients in end-of-life care, who receive generalist palliative care provided by general practitioners, home care services, staff in long-term care facilities, and staff on hospital wards. The recommendations may also be useful to primary care providers, which may, however, struggle to implement them fully due to limitations on resources such as multi-professional teams and out-of-hours service provision [20, 32]. In line with general recommendations on timely integrating palliative care in the treatment of for terminally ill patients, we consider it crucial to involve palliative care specialists at an early stage of treatment, where symptom control proves challenging and especially where a reduction of consciousness is the only means of achieving relief of symptoms [34]. A future project will centre on adapting the recommendations to generalist palliative care, taking into account the associated challenges [32, 35].

Intentional sedation and specialist palliative home care

The recommendations focus on specialist palliative inpatient and home care. The year 1990 saw the first ever publication on sedation in palliative care that discussed patients treated with sedative drugs at home [36]. This work initiated an ongoing debate around which types of intentional sedation are possible in the home setting; previously published research and recommendations suggest that this depends on characteristics of the specific setting and particularly on the staffing levels specialist teams can provide [13, 20, 37, 38]. The recommendations we outline here are suitable for use in both inpatient and home care settings. Only propofol, a narcotic, is not recommended for use in home care because of its smaller therapeutic window and its higher risks compared to midazolam. This is in line with other national and regional recommendations [2, 38,39,40].

Strengths and weaknesses of the study

The study’s interdisciplinary, holistic approach was among its major strengths, balancing the view from clinical practice with normative dimensions of the issues by virtue of the in-depth discussions that led to agreement on a shared terminology. We accounted for the fact that German law reserves the prescription of sedative drugs to physicians by including a relatively high proportion of physicians in the panel.

We faced a number of challenges during the study, among which was a necessary switch from face-to-face formats to videoconferences due to the COVID-19 pandemic. This had the potential to impact the quality of discussions; participants, however, rapidly became accustomed to the online formats, which indeed proved helpful to their attendance.

Our inclusion of consortium members in the Delphi panel may appear at first glance to have impacted its objectivity; we mitigated this potential limitation by the anonymity of the Delphi process, which was not a feature of the consortium members’ discussions.

It is possible to take the view that our use of only one Delphi round limited the quality of the consensus process. The iterative procedure in which the multidisciplinary and multiprofessional consortium created the first and consecutive drafts of the recommendations was driven by expert feedback and undergirded by the consortium members’ broad research and practical expertise in this area. In our view, this justifies the use of a single Delphi round.

The PPI participants had a consultative role in the process, meaning their opportunities to influence decisions such as those on methodology were limited. Nevertheless, representatives of patients and the public were involved in the final approval of the recommendations and had full voting rights [41]. Some patient and public representatives felt overwhelmed with the use of medical jargon and the number of complex topics discussed in the consortium meetings. We responded to their request for better preparation for the meetings by, for example, circulating the agenda and relevant documents to them beforehand. The feedback given by PPI participants on the project suggests that not all of them felt they had taken a significant part in the process; this notwithstanding, PPI participants appreciated the transparency of the research process and the valuing of their experience and perspectives, and spoke positively of the experience of meeting new and interesting people they would not have had the opportunity to meet otherwise.

What this study adds

This study has made available a set of best practice recommendations on the use of sedative drugs in specialist inpatient and home palliative care settings, with transparent reporting on their development and their approval by experts.


The best practice recommendations created in this study provide palliative care professionals with a legally and ethically sound basis for the use of sedative drugs and intentional sedation at the end of life and may help support professionals in making challenging decisions. We believe that future work should focus on implementing and testing the feasibility of a complex intervention, designed on the basis of these recommendations, in specialist end-of-life care settings. It should further seek to assess the effectiveness of this intervention and enable greater participation for representatives of patients and the wider public.

Availability of data and materials

Our data protection information to participants guaranteed their anonymity in any presentation or dissemination of the study’s findings. As the participants’ responses contained detailed information on their individual experiences and views on the practice of sedative use in palliative care, it is not possible to anonymise this data completely. The raw data are therefore unavailable. Please contact the corresponding author with specific enquiries; she may be able, within reason, to extract data relating to specific research questions.


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We are grateful to all participating patient and public involvement participants for their valuable input and feedback throughout the project and for all the time they invested.

We likewise thank all healthcare professionals, patients and family members who were part of the project for their time and involvement.

We thank all project partners: the palliative care units in Universitätsklinikum Erlangen, Universitätsklinikum München, Klinikum Neumarkt, Universitätsklinikum Regensburg, Amberg, Augsburg, Bamberg, Jena, Dresden and Würzburg, and the specialist palliative home care teams at Universitätsklinikum München, Fürth, Amberg, Bamberg, Frankfurt, Jena and Dresden.

The authors extend their cordial thanks to Anna Aechter (student assistant) for her support with internet and literature searches and recruitment of participants to the study.

The German Association for Palliative Medicine provided contact details of relevant experts and supported the dissemination of the recommendations in print and online.


Open Access funding enabled and organized by Projekt DEAL. This study is part of the SedPall project, which was conducted with generous financial support from the German Federal Ministry of Education and Research (BMBF) (grant 01GY1702A-C) and managed by the DLR Project Management Agency.

The source of the funding was not involved in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the paper for publication. The layout and printing of the recommendations’ publication were funded by the German Association of Palliative Care (Deutsche Gesellschaft für Palliativmedizin e.V.).

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Ostgathe, Bausewein, Schildmann E., Schildmann J., Seifert, Klein, and Jäger contributed substantially to the conception and design of the study and to the funding proposal.Ostgathe, Kurkowski, Klein, Heckel drafted the manuscript. All other authors contributed to the revision of the draft and approved the final manuscript. Kurkowski, Torres Cavazos, Heckel, Klein, Handtke, Schildman E., Bazata, Meesters, Schildmann J., Kremling, Ziegler, Jäger, Ostgathe, and Seifert contributed to the collection, analysis, and interpretation of data.

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Correspondence to Maria Heckel.

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The overall study was approved by the Local Research Ethics Committes of Friedrich- Alexander-Universität Erlangen-Nürnberg (FAU) (No. 376_16 Bc, 22 December 2016) and Ludwig-Maximilians-Universität München: (No. 18–191, 19 April 2018) and by the appointed data protection officers. Participants provided written informed consent.

All procedures performed in studies involving human participants took place in accordance with the ethical standards of the local research committee and the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

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The manuscript does not contain any individual person’s data in any form.

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The authors declare no competing interests.

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Ostgathe, C., Bausewein, C., Schildmann, E. et al. Expert-approved best practice recommendations on the use of sedative drugs and intentional sedation in specialist palliative care (SedPall). BMC Palliat Care 22, 126 (2023).

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