NCT01021696

The Impact of Pain on Behavioural Disturbances in Patients With Moderate and Severe Dementia. A Cluster Randomized Trial

Completed Phase 2/Phase 3 Last updated 9 August 2011

What this trial tests

Phase 2/Phase 3 trial testing Paracetamol in Dementia in 352 participants. Completed in 1 October 2010.

Timeline

1 November 2009

Primary endpoint
1 July 2010

1 October 2010

Quick facts

Lead sponsor	University of Bergen
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	352
Start date	1 November 2009
Primary completion	1 July 2010
Estimated completion	1 October 2010
Sites	18 locations across Norway

Drugs / interventions tested

• Paracetamol (Paracetamol) — full drug profile →
• Morphine
• Buprenorphine plaster — full drug profile →
• Pregabalin (Pregabalin) — full drug profile →

Conditions studied

• Dementia — all drugs for Dementia →
• Pain — all drugs for Pain →
• Agitation — all drugs for Agitation →

Sponsor

University of Bergen

Who can join

65 and older, any sex, with Dementia or Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Cohen-Mansfield Agitation Inventory - long form (CMAI)
  Time frame: CMAI will be used during the screening/inclusion process, at week 2, 4, 8, and 12.
  CMAI has 29-item (max. score 203) to assess agitated behaviours in NH-patients. A six-point rating scale assesses the frequency with which patients manifest BPSD evaluating 29 agitated behaviours, ranging from never, less than once a week, but still occurring, once or twice a week, several times a week, once or twice a day, several times a day or several times an hour. Items are presented in four

Sponsor's own description

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

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of treating pain to reduce behavioural disturbances in residents of nursing homes with dementia: cluster randomised clinical trial.
   Husebo BS, Ballard C, Sandvik R, Nilsen OB, et al · · 2011 · cited 291× · PMID 21765198 · DOI 10.1136/bmj.d4065
2. The MOBID-2 pain scale: reliability and responsiveness to pain in patients with dementia.
   Husebo BS, Ostelo R, Strand LI. · · 2014 · cited 71× · PMID 24799157 · DOI 10.1002/ejp.507
3. Impact of a stepwise protocol for treating pain on pain intensity in nursing home patients with dementia: a cluster randomized trial.
   Sandvik RK, Selbaek G, Seifert R, Aarsland D, et al · · 2014 · cited 62× · PMID 24819710 · DOI 10.1002/ejp.523
4. The Interactive Relationship between Pain, Psychosis, and Agitation in People with Dementia: Results from a Cluster-Randomised Clinical Trial.
   Habiger TF, Flo E, Achterberg WP, Husebo BS. · · 2016 · cited 34× · PMID 27247487 · DOI 10.1155/2016/7036415
5. Aromatherapy and Aromatic Plants for the Treatment of Behavioural and Psychological Symptoms of Dementia in Patients with Alzheimer's Disease: Clinical Evidence and Possible Mechanisms.
   Scuteri D, Morrone LA, Rombolà L, Avato PR, et al · · 2017 · cited 28× · PMID 28465709 · DOI 10.1155/2017/9416305
6. Evidence for accuracy of pain assessment and painkillers utilization in neuropsychiatric symptoms of dementia in Calabria region, Italy.
   Scuteri D, Garreffa MR, Esposito S, Bagetta G, et al · · 2018 · cited 26× · PMID 30127123 · DOI 10.4103/1673-5374.237125