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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: Alfentanil; Drug: Diamorphine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Gloucestershire
    • Cheltenham, Gloucestershire, United Kingdom, GL53 0QJ
      • Sue Ryder Care Leckhampton Court Hospice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Gloucestershire Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Paul Perkins, MBBCh FRCP, Gloucestershire Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: January 13, 2010
• First Submitted That Met QC Criteria: January 13, 2010
• First Posted (ESTIMATE): January 14, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 15, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Alfentanil; Heroin
• Other Study ID Numbers: 07/Q0104/47