Diamorphine or Alfentanil for Subcutaneous Use in Hospice In-patients?
Information source: Gloucestershire Hospitals NHS Foundation Trust
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: Alfentanil (Drug); Diamorphine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Gloucestershire Hospitals NHS Foundation Trust Official(s) and/or principal investigator(s): Paul Perkins, MBBCh FRCP, Principal Investigator, Affiliation: Gloucestershire Hospitals NHS Foundation Trust
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.
Clinical Details
Official title: An Open-label Pilot Comparison Between Alfentanil and Diamorphine for Palliative Care Patients Who Require Subcutaneous Opioids
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: 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.
Secondary outcome: Change in MDAS between Days 0 and 7The change in the BPI-SF The change in BPI-SF The difference in proportion of patients taking laxatives The change in nausea visual analogue scale Change in the number of vomits Change in nausea visual analogue scale Change in the number of vomits Change in the total dosage of breakthrough medication (number of doses x dosage) Change in the total dosage of breakthrough medication (number of doses x dosage)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sue Ryder Care Leckhampton Court Hospice, Cheltenham, Gloucestershire GL53 0QJ, United Kingdom
Additional Information
Starting date: September 2010
Last updated: March 15, 2015
|