Pain in Patients With Dementia and Behavioural Disturbances

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

In nursing homes (NHs) 80% of the patients have dementia, between 60%-80% exhibit behavioural disturbances (BPSD), and more than 60% have pain. Both pain and BPSD is more common in those with severe dementia. Since older persons with dementia have less communicative skills, suffer from more pain and exhibit more agitation, pain may be a contributing factor in these patients. More than 40% of patients with BPSD are treated with neuroleptics despite described side-effects. There is an urgent need to investigate the impact of individual pain management on BPSD in patients with dementia.

It was hypothesized that

• pain increase BPSD in patients with dementia

• individual pain treatment decrease BPSD in patients with dementia

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bergen
• Collaborator: The Research Council of Norway
• Treatments: Acetaminophen; Buprenorphine; Morphine; Pregabalin

Criteria

Inclusion Criteria:

• Aged 65 and older

• Residing in the NHs for at least 4 weeks

• Dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association 1994), FAST score > 4 (Hughes 1982).

• Clinically relevant BPSD, operationally defined as CMAI score ≥ 39 or higher or/and at least one week history of agitation or aggression (Koss 1997).

• Written, informed consent provided by the participant (if they have capacity) or assent (if they do not have capacity) and a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant.

Exclusion Criteria:

• Clinician responsible for care, or study clinician considers that the patient suffers from any physical condition, which would make participation in the trial distressing or likely to increase suffering

• Advanced severe medical disease/disorder with expected survival less than 6 months or that could interfere with participation

• Psychosis or other severe mental disorder prior to dementia diagnosis;

• Severe aggression (≥8) on item 3 of the NPI subscale, with aggression as the predominant symptom

• Schizophrenia, schizoaffective disorder and bipolar disorder

• Uncontrolled epilepsy

• Severe liver impairment

• Renal failure, as measured by or equivalent to an estimated creatinine clearance of < 50mL/min/1.73m,

• Severe injury or anaemia (Hb < 8.5 mmol/l), comatose state, current enrolment in another experimental protocol.

• Known allergy or adverse reaction to Paracetamol, Morphine ret, Buprenorphine plaster or pregabalin