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Nasal Fentanyl and Buccal Midazolam for Dying Patients

NCT02009306 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-05-09

No results posted yet for this study

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.

Conditions

  • Terminal Cancer

Interventions

DRUG

PecFent and Epistatus

PecFent will be supplied by Archimedes Pharma as two strengths of nasal spray solution at 1000 or 4000 mcg/mL fentanyl (as citrate). One spray contains 100 mcg or 400 mcg fentanyl (as citrate). Each bottle contains 1.55 ml ensuring delivery of 8 sprays of 100 or 400 mcg fentanyl (as citrate). PecFent is a commercially available product and packaging will be in accordance with the manufacturing authorisations (EU/1/10/644/001, EU/1/10/644/002, EU/1/10/644/005, EU/1/10/644/003, EU/1/10/644/004, EU/1/10/644/006). Epistatus will be supplied by Special Products Ltd. as buccal solution, packed in bottles containing solution for up to 4 x 1 ml doses, as per "Specials" licence. A pack also includes 4 x oral syringes used to administer the solution to the buccal cavity on either side of the mouth.

DRUG

Standard subcutaneous medication

Subcutaneous as needed medication will include: * Opioids for pain or dyspnoea * Diamorphine * Oxycodone * Fentanyl * Benzodiazepine and / or anti-psychotic for agitation * Midazolam * Levomepromazine * Haloperidol Anti-emetic for nausea * Cyclizine * Metoclopramide * Haloperidol * Levomepromazine * Anti-secretory drug for respiratory secretions * Glycopyrronium * Hyoscine butylbromide * Hyoscine hydrobromide

DRUG

Epistatus Alone

Epistatus will be supplied by Special Products Ltd. as buccal solution, packed in bottles containing solution for up to 4 x 1 ml doses, as per "Specials" licence. A pack also includes 4 x oral syringes used to administer the solution to the buccal cavity on either side of the mouth.

Sponsors & Collaborators

  • Gloucestershire Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Paul Perkins, MB BCh FRCP (UK) · Gloucestershire Hospitals NHS Foundation Trust and

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02009306 on ClinicalTrials.gov