Paracetamol to enhance quality of life and daily function and to decrease care dependency in advanced dementia: A randomized, double-blind, placebo-controlled crossover trial in long-term care facilities.
Completed
- Conditions
- Dementia10012272
- Registration Number
- NL-OMON47642
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 95
Inclusion Criteria
Diagnosis of dementia, Reisberg Global Deterioration Scale 5-7
Age 65 years or older
QUALIDEM (Quality of life) score below the expected median score of 70)
Not using any pain medication one week before start study. Residents with PRN prescribed paracetamol (as needed) are also eligible, if the use of paracetamol in the last week was less than 3 grams/week.
Exclusion Criteria
* Presence of a severe psychiatric disorder
* Severe liver insufficiency/disease
* Use of >4 units alcohol per day
* Allergy to study drugs
* Concomitant use of flucloxacillin, carbamazepine, fenytoïne, fenobarbital, isoniazide and/or rifampicine
* Weight < 50 kg
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The difference between baseline QoL and follow-up scores (QUALIDEM and DS-DAT).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Neuropsychiatric symptoms (NeuroPsychiatric Inventory-Nursing Homes)<br /><br>ADL (Katz-15)<br /><br>Care dependency (Care Dependency Scale)<br /><br>Dementia severity (Reisberg Global Deterioration Scale)<br /><br>Pain (MOBID-2 pain scale)<br /><br>Medication use</p><br>