Pain assessment in advanced dementia. Validity of the German PAINAD (= BESD) - A prospective double-blind randomised placebo-controlled trial
Phase 3
- Conditions
- R52Pain, not elsewhere classified
- Registration Number
- DRKS00000525
- Lead Sponsor
- Agaplesion Bethesda Klinik Ulm, Akademisches Krankenhaus der Universität Ulm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Diagnosis of dementia (Alzheimer’s disease, vascular type and combined), non-communicative patients MMSE < 20, PAINAD-G-score = 4 during activities, no analgesic medication or only medication of WHO – Stage I (will be continued unchanged), highly pain-associated diseases (such as arthrosis, chronic back pain), informed consent of the guardian
Exclusion Criteria
Participation in different studies, cancer, other forms of dementia differing from the above, other diseases causing communication impairments (such as apoplexy, Parkinson’s, multiple sclerosis), analgesic medication of WHO – Stage II or III, adverse effect of Oxycodone and contra- indication against Oxycodone according to the instruction leaflet
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method