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Completed

NCT Number: NCT01049672

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sue Ryder Care Leckhampton Court Hospice

Cheltenham, Gloucestershire, GL53 0QJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

alfentanil

Drug

Titrated to a maximum dose of 50mg in 24 hours subcutaneously

Diamorphine

Drug

Titrated to a maximum dose of 500mg in 24 hours given subcutaneously

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.

    Time frame: day 3

Secondary outcomes

  1. Change in MDAS between Days 0 and 7

    Time frame: Day 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.

  2. The change in the BPI-SF

    Time frame: Day 3

    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.

  3. The change in BPI-SF

    Time frame: Day 7

    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.

  4. The difference in proportion of patients taking laxatives

    Time frame: Day 7

    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.

  5. The change in nausea visual analogue scale

    Time frame: Day 3

    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.

  6. Change in the number of vomits

    Time frame: Day3

    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.

  7. Change in nausea visual analogue scale

    Time frame: Day 7

    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

  8. Change in the number of vomits

    Time frame: Day 7

    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.

  9. Change in the total dosage of breakthrough medication (number of doses x dosage)

    Time frame: Day 3

    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

  10. Change in the total dosage of breakthrough medication (number of doses x dosage)

    Time frame: Day 7

    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

Sponsors and collaborators

Lead sponsor

Gloucestershire Hospitals NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: DASH

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 14, 2010
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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