Pain assessment in advanced dementia. Validity of the German PAINAD (= BESD) - A prospective double-blind randomised placebo-controlled trial

Pain assessment in advanced dementia. Validity of the German PAINAD (= BESD) - A prospective double-blind randomised placebo-controlled trial - PAINAD II Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000525

Enrollment

Registered

2010-08-24

Start date

2010-09-17

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R52

Interventions

Group 1: Interventional group: will be treated initially with the opioid Oxycodon in a standard dosis of 10 mg Oxycodonhydrochloride and after three hours with a placebo. Group 2: Control group: will

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To examine the validity of the PAINAD-G scale and to clarify whether it actually measures pain effectively. Difference of the pain behaviour between t1-t2, measured by the PAINAD-G scale.	—

Secondary

Measure	Time frame
To compare the PAINAD-G scale with other monitoring scales for measuring pain behaviour with people suffering from dementia (BISAD, CNPI, ALGOPLUS), and to prove the correlation of these four instruments at the measuring points. Difference of the pain behaviour between t1-t2, measured by the BISAD, CNPI and ALGOPLUS scale. Difference of the pain behaviour between t2-t3, measured by all four monitoring assessments. Correlation of all the four instruments at the measuring points.	—

Measure

Time frame

To compare the PAINAD-G scale with other monitoring scales for measuring pain behaviour with people suffering from dementia (BISAD, CNPI, ALGOPLUS), and to prove the correlation of these four instruments at the measuring points. Difference of the pain behaviour between t1-t2, measured by the BISAD, CNPI and ALGOPLUS scale. Difference of the pain behaviour between t2-t3, measured by all four monitoring assessments. Correlation of all the four instruments at the measuring points.

—

Countries

Germany

Contacts

Public ContactAlbert Lukas

Malteser Krankenhaus Seliger Gerhard Bonn/Rhein-Sieg, Akademisches Lehrkrankenhaus der Universität Bonn

albert.lukas@malteser.org+49 (0)228 - 6481512

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026