Introduction Many patients want to stay at home to die. They invariably become unable to take oral medication during their terminal phase. Symptoms are usually controlled by subcutaneous medications. There have been no studies on nasal fentanyl (NF) or buccal midazolam (BM) to control symptoms in the dying.
Objective To establish how best to conduct a definitive, randomised controlled trial (RCT) to determine whether NF and BM administered by families, for patients dying at home, lead to faster and better symptom control and fewer community nursing visits than standard breakthrough medication by healthcare professionals.
Methods This open-label mixed-method feasibility RCT compared the efficacy of NF and BM by family members to standard breakthrough medication by nurses for the terminally ill in a specialist palliative care unit. Partway through the study, a third observational arm was introduced where BM alone was used. The primary outcomes were whether recruitment and randomisation were possible, assessment of withdrawal and drop-out, and whether the methods were acceptable and appropriate.
Results Administration of NF and BM was acceptable to patients and families. Both were well tolerated. We were unable to obtain quality of life data consistently but did get time period data for dose-controlled symptoms.
Conclusions Study participation in a hospice population of the dying was acceptable. The results will help guide future community study planning.
Trial registration number NCT02009306.
- terminal care
- hospice care
- home care
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Contributors PP conceived the study. AP and EH made substantial contribution to its design. AP collected most of the data. RKA was responsible for data analysis. PP is the guarantor.
Funding Kyowa Kirin provided PecFent supplies free of charge and lock boxes for the trial. Special Products provided Epistatus free of charge. Both companies provided funding to enable the study to be conducted.
Competing interests PP and EH have in the past received financial support to attend educational events from Kyowa Kirin.
Patient consent for publication Not required.
Ethics approval The study was approved by Gloucestershire Research Support Service, the Sue Ryder Research Governance Group, the National Research Ethics Service Committee South Central – Berkshire and the MHRA. The clinical trial was registered in EudraCT, the EMEA database for clinical trials (code EUDRACT 2013-005009-30).
Provenance and peer review Not commissioned; internally peer reviewed.
Data availability statement Data are available upon request