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

Cancer Clinical Trial

— DASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049672
• Other study ID #: 07/Q0104/47
• Status: Completed
• Phase: N/A
• First received: January 13, 2010
• Last updated: March 15, 2015
• Start date: September 2010
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Gloucestershire Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Alfentanil
Titrated to a maximum dose of 50mg in 24 hours subcutaneously
• Diamorphine
Titrated to a maximum dose of 500mg in 24 hours given subcutaneously

Locations

Country	Name	City	State
United Kingdom	Sue Ryder Care Leckhampton Court Hospice	Cheltenham	Gloucestershire

Sponsors (1)

Lead Sponsor	Collaborator
Gloucestershire Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes