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
1 other identifier
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cancer
Started Sep 2010
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2010
CompletedFirst Posted
Study publicly available on registry
January 14, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedMarch 17, 2015
March 1, 2015
4.2 years
January 13, 2010
March 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Change in MDAS between Days 0 and 7
Day 7
The change in the BPI-SF
Day 3
The change in BPI-SF
Day 7
The difference in proportion of patients taking laxatives
Day 7
The change in nausea visual analogue scale
Day 3
- +5 more secondary outcomes
Study Arms (2)
Alfentanil
ACTIVE COMPARATORHospice in-patients who require subcutaneous strong opioid administration will be given alfentanil
Diamorphine
ACTIVE COMPARATORHospice in-patients who require strong opioids will be given diamorphine
Interventions
Eligibility Criteria
You may qualify if:
- To be thought by a hospice doctor to require parenteral strong opioids.
- To have an estimated prognosis of less than 1 year.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sue Ryder Care Leckhampton Court Hospice
Cheltenham, Gloucestershire, GL53 0QJ, United Kingdom
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Perkins, MBBCh FRCP
Gloucestershire Hospitals NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Investigator
Study Record Dates
First Submitted
January 13, 2010
First Posted
January 14, 2010
Study Start
September 1, 2010
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
March 17, 2015
Record last verified: 2015-03