The results of this feasibility study suggest that a definitive study can be done, but that minor changes are needed to the protocol to standardise the administration of clinically assisted hydration (which may reduce the incidence of certain adverse effects).

Place of death is undoubtedly an important factor in achieving a good death for some patients and carers. However, for others a home death is either unimportant or to be avoided. The results of this study, and the results of similar studies, suggest that place of death may not be a good marker of the quality of end of life care.

When discussions around end-of-life choices do occur, carers generally appear to agree with the patients' preferences around end-of-life treatment, and preferred place of death.

BackgroundThe provision of clinically assisted hydration at the end of life is one of the most contentious issues in medicine, and indeed within the general population. The reasons for contention include: a) the lack of evidence for or against; b) the disparate opinions of healthcare professionals; and c) the generally positive opinions of patients and their carers about clinically assisted hydration.Methods/designThe study is a cluster randomised trial to assess the feasibility of conducting an adequately powered, randomised controlled trial of clinically assisted hydration in patients with cancer in the last days of life. Twelve sites, four National Health Service (NHS) hospitals and eight NHS/voluntary sector hospices in the United Kingdom, will be randomised to give either standard intervention A: continuance of oral intake and regular mouth care, or standard intervention B: continuance of oral intake, regular mouth care and clinically assisted hydration. Patients will be included if they: i) have a diagnosis of cancer; ii) are aged ≥ 18 yr; iii) have an estimated prognosis of ≤ 1 week and iv) are unable to maintain sufficient oral intake (1 L per day, measured/estimated); and v) are able to give informed consent. Patients will be excluded if they have contra-indications to receiving clinically assisted hydration. The primary endpoint of interest is the frequency of hyperactive delirium (‘terminal agitation‘), and this will be assessed using the Modified Richmond Agitation and Sedation Scale (administered every four hours). Other data to be collected include the frequency of pain, respiratory secretions (‘death rattle‘), dyspnoea, nausea and vomiting, adverse effects to clinically assisted hydration and overall survival. In addition, data will be collected on the use of anti-psychotic drugs, sedative drugs, analgesics, anti-secretory drugs and other end-of-life medication. The study has obtained full ethical approval.DiscussionA randomised controlled trial of clinically assisted hydration in end-of-life care is urgently required. This feasibility study will allow methodological and ethical issues to be understood and addressed to ensure that a robust, adequately powered, randomised controlled trial is designed.Trial registrationClinicalTrials.gov NCT02344927 (registered 4 June 2014).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0988-3) contains supplementary material, which is available to authorized users.

The pharmacokinetics of the sublingual fentanyl orally disintegrating tablet appear to be negatively affected by the presence of salivary gland hypofunction, although the moistening of the oral cavity before dosing results in a pharmacokinetic profile similar to that seen with the giving of pilocarpine hydrochloride.