Nasal fentanyl alone plus buccal midazolam: an open-label, randomised, controlled feasibility study in the dying.

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.