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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: McGill Pain Questionnaire Short Form(MPQ-SF) Brief Pain Inventory Short Form (BPI-SF)These measures were recommended by an EAPC Expert Working Group for pain syndrome characterization Memorial Delirium Assessment Scale (MDAS). This has been validated in an advanced cancer population and used recently with hospice in-patients. Nausea Visual Analogue Scale (VAS) Nausea Duration over last 24 hours 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: BPI-SF MDAS Nausea VAS Number of vomits in previous 24 hours In addition the following measurements will be taken: Stool chart for previous 24 hours Breakthrough medication (number of doses and dosage) used Laxatives taken Other changes to medication Patients will cease participation after assessment on day 7.

Official Title
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An Open-label Pilot Comparison Between Alfentanil and Diamorphine for Palliative Care Patients Who Require Subcutaneous Opioids

Conditions
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Cancer

Intervention / Treatment
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* Drug: Alfentanil
* Drug: Diamorphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be thought by a hospice doctor to require parenteral strong opioids. To have an estimated prognosis of less than 1 year. Exclusion Criteria: Inability to read English sufficiently to be able to complete assessment questionnaires. Confusion sufficient so that patient is unable to complete questionnaires. Weakness or fatigue sufficient so that patient is unable to complete questionnaires. Radiotherapy to source of pain in last 4 weeks. Change in corticosteroid dose in last week.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alfentanil<br>Hospice in-patients who require subcutaneous strong opioid administration will be given alfentanil | Drug: Alfentanil<br>* Titrated to a maximum dose of 50mg in 24 hours subcutaneously<br>|
| Active Comparator: Diamorphine<br>Hospice in-patients who require strong opioids will be given diamorphine | Drug: Diamorphine<br>* Titrated to a maximum dose of 500mg in 24 hours given subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in MDAS will be calculated from day 0 to day 3 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise. |  | day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MDAS between Days 0 and 7 | The change in MDAS will be calculated from day 0 to day 7 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise. | Day 7 | 
| The change in the BPI-SF | The change in BPI-SF will be calculated from day 0 to day 3 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise. | Day 3 | 
| The change in BPI-SF | The change in BPI-SF will be calculated from day 0 to day 7 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise. | Day 7 | 
| The difference in proportion of patients taking laxatives | The difference in proportion of patients taking laxatives will be compared between the two groups using the confidence interval on the difference of two proportions. | Day 7 | 
| The change in nausea visual analogue scale | The change in nausea visual analogue scale will be calculated from day 0 to day 3 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise. | Day 3 | 
| Change in the number of vomits | The change in number of vomits will be calculated from day 0 to day 3 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise. | Day3 | 
| Change in nausea visual analogue scale | The change in nausea visual analogue scale will be calculated from day 0 to day 7 and compared betwen the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-WhitneyU test otherwise | Day 7 | 
| Change in the number of vomits | The change in number of vomits will be calculated from day 0 to day 7 and compared betwen the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise. | Day 7 | 
| Change in the total dosage of breakthrough medication (number of doses x dosage) | The change in the total dosage of breakthrough medication will be calculated from day 0 to day 3 and compared betwen the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-WhitneyU test otherwise | Day 3 | 
| Change in the total dosage of breakthrough medication (number of doses x dosage) | The change in the total dosage of breakthrough medication will be calculated from day 0 to day 7 and compared betwen the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-WhitneyU test otherwise | Day 7 |