Pain in older patients with dementia MedDRA version: 9.1 Level: LLT Classification code 10050533 Term: Pain assessment MedDRA version: 9.1 Level: LLT Classification code 10000428 Term: Ache NOS
Conditions
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age ≤75 years A diagnosis of dementia of any type Difficulty to verbalize Persistent pain as testified by a score >5 at the DOLOPLUS-2 scale Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: Participation to other studies in the last 3 months Refuse or inability to give consent Terminal state On an analgesic medication for over 1 month Clinical evidence suggesting an acute pain condition of any intensity Contraindication to tramadol once-a-day Epilepsy or current pharmacologic treatment with carbamazepine Juvenile intellectual disability Concomitant treatment with MAO inhibitors Presence of any disease or condition which at investigators? judgment might interfere with the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy ? pain intensity, pain interference, pain relieve, physical performance, functional status;Secondary Objective: Tolerability - blood pressure, creatinine clearance, anemia, adverse events;Primary end point(s): Efficacy ? pain intensity, pain interference, pain relieve, physical performance, functional status | — |
Countries
Italy
Outcome results
None listed