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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Gloucestershire Hospitals NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Paul Perkins, Gloucestershire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01049672
First received: January 13, 2010
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Palliative Care
Drug: Alfentanil
Drug: Diamorphine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: An Open-label Pilot Comparison Between Alfentanil and Diamorphine for Palliative Care Patients Who Require Subcutaneous Opioids

Resource links provided by NLM:


Further study details as provided by Gloucestershire Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 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. [ Time Frame: day 3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in MDAS between Days 0 and 7 [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
    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.

  • The change in the BPI-SF [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    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.

  • The change in BPI-SF [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
    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.

  • The difference in proportion of patients taking laxatives [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    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.

  • The change in nausea visual analogue scale [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    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.

  • Change in the number of vomits [ Time Frame: Day3 ] [ Designated as safety issue: Yes ]
    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.

  • Change in nausea visual analogue scale [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
    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

  • Change in the number of vomits [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
    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.

  • Change in the total dosage of breakthrough medication (number of doses x dosage) [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    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

  • Change in the total dosage of breakthrough medication (number of doses x dosage) [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049672

Contacts
Contact: Paul Perkins, MB BCh MRCP (UK_ +44 1242 230199 paul.perkins@suerydercare.org

Locations
United Kingdom
Sue Ryder Care Leckhampton Court Hospice Recruiting
Cheltenham, Gloucestershire, United Kingdom, GL53 0QJ
Contact: Paul Perkins, MB BCh MRCP (UK)    +44 1242 230199    paul.perkins@suerydercare.org   
Principal Investigator: Paul Perkins, MB Bch MRCP (UK)         
Sponsors and Collaborators
Gloucestershire Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Paul Perkins, MB BCh MRCP(UK) Gloucestershire Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Paul Perkins, Chief Investigator, Gloucestershire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01049672     History of Changes
Other Study ID Numbers: 07/Q0104/47
Study First Received: January 13, 2010
Last Updated: March 21, 2012
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Alfentanil
Heroin
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 16, 2014