JMIR Publications

ABSTRACT

Background:

Sedation at the end of life is utilised to relieve distressing symptoms including agitation and delirium. Standard care may include infused benzodiazepines or antipsychotics. These agents often result in deep sedation with loss of interaction with loved ones, which may be distressing.

Objective:

The DREAMS trial aims to compare the effects of the alpha-2 agonist dexmedetomidine, a novel palliative care sedative against midazolam, a benzodiazepine when administered by subcutaneous infusion at the end of life, with doses of both agents targeting lighter sedation.

Methods:

Participants were recruited from adult inpatients admitted for end-of-life care under the palliative care team in regional New South Wales, Australia. Inclusion criteria included patients over 18, with a preference for lighter sedation at the end-of-life. Exclusion criteria included severe cardiac dysfunction (contraindication to dexmedetomidine). Participants were consented and placed on a treatment pending list. Upon experiencing terminal deterioration, patients were randomised to either arm 1 (dexmedetomidine) or arm 2 (midazolam) as their treatment arm. These treatments were administered by continuous subcutaneous infusion. The level of consciousness and agitation of the patients were measured by the Richmond Agitation Sedation Score, Palliative version (RASS-PAL) and the Memorial Delirium Assessment Score (MDAS). RASS-PAL assessments were performed by both nursing and medical staff; while MDAS assessments were carried out by medical staff only. Families and patients were asked to complete, as able, a Patient Comfort Assessment form, to gauge perceptions of distress. Data were collected and matched with the breakthrough medication doses administered, along with qualitative comments in the medical record. In addition, the study tracked symptoms and patient functional status, which were recorded as part of the Palliative Care Outcomes Collaborative, a national tracking project for monitoring symptom outcomes in palliative care.

Results:

The DREAMS trial was funded in May 2020, ethics approved in November 2020 and recruited participants from May 2021. Data collection commenced in May 2021, and is anticipated to continue until December 2024. Publication of results anticipated from 2024-2026.

Conclusions:

The evidence base for sedative dosing in palliative care for distress and agitation is not robust, with standard care based primarily on clinical experience and not robust scientific evidence. This study is important because it will compare a standard and a novel sedative used in end-of-life treatment. By assessing the potential efficacy and benefits of both, it seeks to optimise the quality of dying by providing targeted sedation that can improve the communication between dying patients and their loved ones. Clinical Trial: The DREAMS trial was prospectively registered with the Australia New Zealand Clinical Trials Register, registration ACTRN12621000052831.