drugset / Trial / NCT02009306

Nasal Fentanyl and Buccal Midazolam for Dying Patients

NCT02009306

Phase 4 Completed 20 enrolled Gloucestershire Hospitals NHS Foundation Trust
RandomizedParallel-groupOpen-labelTreatment

Summary

When patients are dying they become unable to take oral medication and if they develop symptoms (e.g. pain or agitation) they need to be given a subcutaneous injection of medication. If they are at home this requires that a District Nurse is called and it can take a long time (sometimes hours) for the Nurse to arrive. This can be a very stressful time for the patient and family. There are 2 drug preparations which could potentially be given by family members in the home: Nasal fentanyl (PecFent) Buccal midazolam (Epistatus) If these preparations helped symptoms this would give much quicker symptom control for patients and might mean the District Nurse visit was not needed. In advance of a community based randomised trial of these modes of administration, it is important to assess the feasibility of such an approach in terms of carer acceptability and patient tolerability as well as determine appropriate sample sizes and sampling methods. There are 2 work packages which would help assess feasibility of a community trial: 1. An open label randomised controlled trial comparing the use of PecFent with or without Epistatus versus standard subcutaneous breakthrough medication for the management of breakthrough pain (with or without agitation) in dying hospice patients who either remain in the hospice or go home. 2. A qualitative interview study to capture the thoughts of relatives of these patients about the use of these preparations.

Timeline

Start
2017-01-23
Primary completion
2018-02-28
Completion
2018-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 100 ug Intranasal
Subject Fentanyl Other / unclassified 200 ug Intranasal
Subject Fentanyl Other / unclassified 400 ug Intranasal
Subject Fentanyl Other / unclassified 800 ug Intranasal
Subject Midazolam Small molecule 2.5 mg Intravenous
Subject Midazolam Small molecule 5 mg Intravenous
Subject Midazolam Small molecule 10 mg Intravenous
Background Cyclizine Small molecule Subcutaneous
Background Diacetylmorphine Small molecule Subcutaneous
Background Glycopyrronium Unknown Subcutaneous
Background Haloperidol Other / unclassified Subcutaneous
Background Hyoscine butylbromide Unknown Subcutaneous
Background Levomepromazine Small molecule Subcutaneous
Background Metoclopramide Small molecule Subcutaneous
Background Oxycodone Other / unclassified Subcutaneous
Background Scopolamine Unknown Subcutaneous

Indications

No indication recorded.