Death rattle (DR), caused by mucus in the respiratory tract, occurs in about half of patients who are in the dying phase. Relatives often experience DR as distressing. Anticholinergics are recommended to treat DR, although there is no evidence for the effect of these drugs. Anticholinergic drugs decrease the production of mucus but do not affect existing mucus. We therefore hypothesize that these drugs are more effective when given prophylactically.
We set up a randomized double-blind, placebo-controlled, multi-center study evaluating the efficacy of prophylactically given subcutaneous scopolaminebutyl for the prevention of DR in the dying phase. The primary outcome is the occurrence of DR defined as grade ≥ 2 according to the scale of Back measured by a nurse at 2 consecutive time points with an interval of 4 h. Secondary outcomes include adverse effects, quality of dying, quality of life in the last three days and bereavement. A sub-study will explore the experience of participating in a clinical trial in the dying phase from the perspective of relatives. Four hospices will include 200 patients.
This is the first double-blind placebo-controlled study to prevent DR in patients in the hospice setting. Research in dying patients is challenging. We will apply ethical and organizational strategies as suggested in the literature.
The trial is retrospectively registered in the Dutch Trial register, identifier NTR 6438 June 2017. EudractCT number 2016–002287-14.
van Zuylen L, van Veluw H, van Esch HJ. Care for the dying, National Guideline. 2010.
Lokker ME, van Zuylen L, van der Rijt CC, van der Heide A. Prevalence, impact, and treatment of death rattle: a systematic review. J Pain Symptom Manag. 2014;47(1):105–22. CrossRef
Shimizu Y, Miyashita M, Morita T, Sato K, Tsuneto S, Shima Y. Care strategy for death rattle in terminally ill cancer patients and their family members: recommendations from a cross-sectional nationwide survey of bereaved family members' perceptions. J Pain Symptom Manag. 2014;48(1):2–12. CrossRef
Likar R, Molnar M, Rupacher E, Pipam W, Deutsch J, Mörtl M, Baumgartner J, Griessinger N, Sittl R. A clinical study examining the efficacy of scopolamin-hydrobromide in patiënts with death rattle (a randomized, double-blind, placebo-controlled study). Zeitschrift fuer Palliativmedizin. 2002;3:15–9. CrossRef
Wildiers H, Dhaenekint C, Demeulenaere P, Clement PM, Desmet M, Van Nuffelen R, et al. Atropine, hyoscine butylbromide, or scopolamine are equally effective for the treatment of death rattle in terminal care. J Pain Symptom Manag. 2009;38(1):124–33. CrossRef
Mercadante S. Death rattle: critical review and research agenda. Support Care Cancer. 2014;22(2):571–5. CrossRef
Wee B, Hillier R. Interventions for noisy breathing in patients near to death. Cochrane Database Syst Rev. 2008;1 CD005177.
Heisler M, Hamilton G, Abbott A, Chengalaram A, Koceja T, Gerkin R. Randomized double-blind trial of sublingual atropine vs. placebo for the management of death rattle. J Pain Symptom Manag. 2013;45(1):14–22. CrossRef
IEW G. ICH Harmonised Tripartite Guideline: guideline for Good Clinical Practice 1996.
de Lemos J, Tweeddale M, Chittock D. Measuring quality of sedation in adult mechanically ventilated critically ill patients. the Vancouver Interaction and Calmness Scale Sedation Focus Group J Clin Epidemiol. 2000;53(9):908–19. PubMed
Casarett DJ, Karlawish JH. Are special ethical guidelines needed for palliative care research? J Pain Symptom Manag. 2000;20(2):130–9. CrossRef
- Scopolaminebutyl given prophylactically for death rattle: study protocol of a randomized double-blind placebo-controlled trial in a frail patient population (the SILENCE study)
Harriëtte J. van Esch
Lia van Zuylen
Esther Oomen–de Hoop
Agnes van der Heide
Carin C. D. van der Rijt
- BioMed Central
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