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Nasal Fentanyl and Buccal Midazolam for Dying Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Gloucestershire Hospitals NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Paul Perkins, Gloucestershire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02009306
First received: November 18, 2013
Last updated: December 8, 2013
Last verified: December 2013
  Purpose

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.

Condition Intervention Phase
Terminal Cancer
Drug: PecFent and Epistatus
Drug: Standard subcutaneous medication
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can Nasal Fentanyl and Buccal Midazolam Give Better Symptom Control for Dying Patients When Compared With Standard Subcutaneous Medication? Pilot Randomised Controlled Trial and Qualitative Interview Study.

Resource links provided by NLM:


Further study details as provided by Gloucestershire Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Time to adequate symptom control ('comfortable') from need for breakthrough medication (in minutes) according to patient (where possible), relatives and staff. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time (in minutes) from need for breakthrough medication (recognition of symptom) to administration of drug. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Need for additional oral or subcutaneous medication [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Time (in minutes) to recurrence of symptoms according to patient (where possible), relatives and staff [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Patient comfort as measured by the Palliative Care Outcome Scale (patient /carer/ staff versions) daily [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Visual analogue scales for pain and agitation completed by patient (where possible), relatives and staff at baseline (Time 0), 15, and 30 minutes. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: April 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PecFent and Epistatus
Medication administered by family / carer for symptoms
Drug: PecFent and Epistatus
Other Name: Fentanyl and Midazolam
Drug: Standard subcutaneous medication
Other Name: Subcutaneous opioids and midazolam
Active Comparator: Standard subcutaneous medication
Standard subcutaneous medication - diamophine and / or midazolam administered by nursing staff
Drug: Standard subcutaneous medication
Other Name: Subcutaneous opioids and midazolam

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  4. taking 60mg or more of oral morphine (or its equivalent) per 24 hours
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02009306

Contacts
Contact: Paul Perkins, MB BCh FRCP (UK) 441242230199 paul.perkins@suerydercare.org

Locations
United Kingdom
Sue Ryder Leckhampton Court Hospice Not yet recruiting
Cheltenham, Gloucestershire, United Kingdom, GL53 0QJ
Contact: Paul Perkins, MB BCh MRCP (UK)    441242230199    paul.perkins@suerydercare.org   
Principal Investigator: Paul Perkins, MB BCh FRCP (UK)         
Sponsors and Collaborators
Gloucestershire Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Paul Perkins, MB BCh FRCP (UK) Gloucestershire Hospitals NHS Foundation Trust and
  More Information

No publications provided

Responsible Party: Paul Perkins, Consultant in Palliative Medicine, Gloucestershire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02009306     History of Changes
Other Study ID Numbers: PecEp1
Study First Received: November 18, 2013
Last Updated: December 8, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Gloucestershire Hospitals NHS Foundation Trust:
Palliative
Symptom control
Hospice
Opioid
Benzodiazepine

Additional relevant MeSH terms:
Fentanyl
Midazolam
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Narcotics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014