Nasal Fentanyl and Buccal Midazolam for Dying Patients

• Status: Completed
• Trial end date: 2018-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gloucestershire Hospitals NHS Foundation Trust
• Treatments: Fentanyl; Midazolam

Criteria

Inclusion Criteria:

Adult hospice in-patients fitting the following criteria will be approached to see if they are willing to participate in the study:

1. diagnosis of terminal cancer and thought to have an estimated prognosis of between 1 and 2 weeks

2. have capacity to consent to participation

3. patients who, in the last 24 hours, have experienced at least one episode of breakthrough pain FOR ARMS 1 OR 2 (RCT) For Arm 3 must have had 1 episode of agitation necessitating the use of a benzodiazepine in the last 24 hours

4. taking 60mg or more of oral morphine (or its equivalent) per 24 hours FOR ARMS 1 OR 2 (RCT) IF taking less than this dose of opioid could be enrolled in Arm 3 (Epistatus alone - change in protocol implemented 28/11/17

5. have carers or family members who would be: willing to give the study medication to the patient likely to be at the hospice at least 50% of the time so that they are likely to be present to administer medication.

Exclusion Criteria:

1. patients / carers / family members who in the opinion of the clinical team would be too distressed by the idea of participation

2. patients with disease of the nasal/buccal mucosa preventing effective absorption of medication

3. families who are unable to administer breakthrough medication e.g. problems with dexterity

4. history of substance abuse - patient or carer / family.

5. people who who might not adequately understand verbal explanations or written information given in English. The pilot is only recruiting 20 patients and Gloucestershire has a only a very small percentage of people who are not English speaking. It has been decided that it is not cost effective to fund translation for this pilot although this information will have to be taken into account when planning a larger study. We will capture information on the numbers of patients that may have been excluded and the languages that might have been needed.

6. Participated in a medicinal trial within the last four months following the guidance from the Association of the British Pharmaceutical Industry.