Palliative Care MedDRA version: 9.1 Level: LLT Classification code 10059513 Term: Palliative care MedDRA version: 9.1 Level: PT Classification code 10059513 Term: Palliative care
Conditions
Interventions
Trade Name: Rapifen
Product Name: alfentanil hydrochloride
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ALFENTANIL HYDROCHLORIDE
CAS Number: 69049065
Concentration unit: mg/ml mill
Sponsors
Gloucestershire Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. To be thought by hospice doctor to require parenteral strong opiods 2. To have an estimated prognosis of less than 1 year Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inability to read English sufficiently to be able to complete assessment questionnaires 2. Confusion sufficient so that the patient is unable to complete the questionnaires 3. Weakness or fatigue sufficient so that the patient in unable to complete the questionnaires 4. Radiotherapy to source of pain in previous 4 weeks 5. Change in corticosteroid dose in previous week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A comparison of alfentanil and diamorphine to be carried out in two parts: 1. An open-label pilot comparison between alfentanil and diamorphine for palliative care patients who require subcutaeous opiods 2. A single (patient)-blinded, randomised, comparison between alfentanil and diamorphine for palliative care patients who require subcutaeous opiods;Secondary Objective: A qualitative assessment of the views of bereaved patients regarding the sypmtom relief of their dying relative;Primary end point(s): Change in the following will be calculated from day 0 to day 3 and compared between the 2 groups 1. Memorial Delerium Assessment Scale 2. Brief Pain Inventory Short Form 3. Nausea visual analogue scale 4. Number of vomits in previous 24 hours 5. Total dosage of breakthrough medication In addition, the number of patients taking laxatives in each group will be compared | — |
Countries
United Kingdom
Outcome results
None listed