Diamorphine or Alfentanil for Subcutaneous Use in Hospice In-patients? (DASH)

Gloucestershire Hospitals NHS Foundation Trust

Status: Completed

Conditions: Cancer

Treatments: Drug: Alfentanil; Drug: Diamorphine

Study type: Interventional

Funder types: Other

Identifiers

NCT01049672

07/Q0104/47

Details and patient eligibility

About

OBJECTIVES:

How does Alfentanil compare with the standard drug Diamorphine for subcutaneous analgesia in the palliative care setting?

STUDY DESIGN:

An open-label pilot comparison between alfentanil and diamorphine for palliative care patients who require subcutaneous opioids.

Full description

STUDY DESIGN

Study 1 - Open Label Pilot Day - 1 Hospice in-patients who are thought by a clinician to need subcutaneous strong opioids will be asked if they wish to take part in the study.

They will be given a patient information leaflet and a 'cooling off period' (a minimum of 1 day) to think about it. If the clinician feels that strong parenteral opioids are needed diamorphine will be commenced immediately (as standard practice).

Day 0 If the patient agrees to take part in the trial they will be asked to complete a consent form and this will be stored with the patient's notes.

The following assessments will be performed:

1. McGill Pain Questionnaire Short Form(MPQ-SF)
2. Brief Pain Inventory Short Form (BPI-SF)These measures were recommended by an EAPC Expert Working Group for pain syndrome characterization
3. Memorial Delirium Assessment Scale (MDAS). This has been validated in an advanced cancer population and used recently with hospice in-patients.
4. Nausea Visual Analogue Scale (VAS)
5. Nausea Duration over last 24 hours
6. Number of vomits in previous 24 hours

Randomisation Once baseline measures are completed the participant will be randomised using the next available of a series of numbered, opaque, sealed envelopes. These will be prepared remotely. Blocking will be used to prevent an imbalance in terms of the number allocated to each group. Block size will be appropriate to the size of the study and not be divulged to the investigators responsible for consent and revealing the allocation. This will reduce the risk of investigators anticipating the allocation for particular patients. A study log will be kept on site where participant details will be completed before the envelope is opened.

Subsequent Days

On each subsequent day the following assessments will be performed:

1. BPI-SF

2. MDAS

3. Nausea VAS

4. Number of vomits in previous 24 hours

   In addition the following measurements will be taken:

5. Stool chart for previous 24 hours

6. Breakthrough medication (number of doses and dosage) used

7. Laxatives taken

8. Other changes to medication

Patients will cease participation after assessment on day 7.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. To be thought by a hospice doctor to require parenteral strong opioids.
2. To have an estimated prognosis of less than 1 year.

Exclusion criteria

1. Inability to read English sufficiently to be able to complete assessment questionnaires.
2. Confusion sufficient so that patient is unable to complete questionnaires.
3. Weakness or fatigue sufficient so that patient is unable to complete questionnaires.
4. Radiotherapy to source of pain in last 4 weeks.
5. Change in corticosteroid dose in last week.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Alfentanil

Active Comparator group

Description:

Hospice in-patients who require subcutaneous strong opioid administration will be given alfentanil

Treatment:

Drug: Alfentanil

Diamorphine

Active Comparator group

Description:

Hospice in-patients who require strong opioids will be given diamorphine

Treatment:

Drug: Diamorphine