An open-label, randomised controlled feasibility study to evaluate whether nasal fentanyl alone and in combination with buccal midazolam give better symptom control to dying patients when compared with standard as needed medication

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Introduction

Many patients want to die at home and they invariably become unable to take oral medication as part of their terminal phase; symptoms are usually controlled using subcutaneous medications. There have been no studies examining the use of nasal fentanyl (NF) or buccal midazolam (BM) to control symptoms at the end of life.

Objective

To establish how best to conduct a definitive randomised controlled trial (RCT) to determine whether NF and BM given by families rather than standard breakthrough medication administered by healthcare professionals for patients dying at home, leads to faster and better symptom control and fewer community nursing visits.

Material and methods

This feasibility open-label RCT compared the efficacy of NF and BM administered by family members with standard breakthrough medication administered by nurses to terminally ill patients in a specialist palliative care unit. Partway through the study, a third observational arm was introduced where BM alone was used as study drug. The primary outcomes were whether recruitment and randomisation were possible; assessment of withdrawal and drop-out rates; and whether the proposed trial methods were acceptable and appropriate.

Results

The administration of NF and BM was considered acceptable by patients and families, and both medications were well tolerated. We were unable to consistently obtain data on quality of life outcome measures but there was no missing data with regards to how long doses controlled symptoms.

Conclusions

Participation in such a study in a hospice population was acceptable. The results will help planning of a future community study.