Trial document




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  DRKS00000525

Trial Description

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Title

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

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Trial Acronym

PAINAD II Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Numerous studies carried out during the last few years have shown that patients with cognitive impairment pain is underreported and inadequately treated. One of the main reasons for this observation is that advanced dementia patients lack the ability to verbally communicate their pain, and there is also a lack of sufficient and adequate instruments for assessing pain in this particular group of people. We consider the “Pain Assessment in Advanced Dementia” (PAINAD) is one of the best prerequisites for reliable pain recognition in patients suffering from dementia. PAINAD-G is an observation instrument with which different parameters such as vocalization (moaning, groaning, crying), breathing (loud strenuous breathing) or facial expression (fearfull and grimmassing) can be closely observed. The observation serves as a basis for recognizing pain even if the patient is no longer able to indicate the pain due to his or her degree of dementia. In our study we would like to prove that the PAINAD-G can reliably detect pain in dementia patients (= validity).

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Brief Summary in Scientific Language

Pain in combination with dementia is a frequent problem which makes pain recognition significantly more difficult. This could result in pain undertreatment of those suffering from dementia. In the last few years, different assessment instruments for pain assessment for this particular group of patients have been developed. However, the available data concerning the validity of these instruments is insufficient. In our opinion, the PAINAD (“Pain Assessment in Advanced Dementia”) pain assessment scale has the best prerequisites for a valid pain detection in dementia. In a pilot study, a good interrater and re-test reliability of the German version of PAINAD (= BESD) could be proven. In the study presented here, the validity of the PAINAD-G scale should be verified by using a double-blind randomised placebo-controlled trial. The interventional group is treated with the opioid Oxycodon in a standard dosis of 10 mg Oxycodonhydrochloride, whilst the control group will only be given a placebo (T1). After three hours, the control group is given Oxycodon and the verum group recieves the placebo (T2). The first measuring point will be taken before the intervention (T1), then three hours following the first medication (T2), and finally six hours after the first treatment. We assume that the determined PAINAD-G value decreases between T1 and T2 in the verum group which shows there is a significant difference between the verum and control groups at the time of T2. The main objective of the study is the validation of the PAINAD-G scale. Pain in those suffering from advanced dementia can thus be better recognized and subsequently treated. As a secondary objective, a comparison with other pain measuring instruments for dementia should take place. BISAD (Beobachtungsinstrument für das Schmerzassessment bei alten Menschen mit schwerer Demenz) a German equivalent of the French version ECPA (Echelle comportemental de la douleur pour personnes âgées non communicantes) as well as the CNPI scale (Checklist of Nonverbal Pain Indicators) and the ALGOPLUS Scale are used here.

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Organizational Data

  •   DRKS00000525
  •   2010/08/24
  •   [---]*
  •   yes
  •   Approved
  •   13/09, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   U1111-1116-6820 
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Health Condition or Problem studied

  •   R52 -  Pain, not elsewhere classified
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Interventions/Observational Groups

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

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Placebo
  •   Diagnostic
  •   Crossover
  •   III
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/09/17
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Agaplesion Bethesda Klinik Ulm, Akademisches Krankenhaus der Universität Ulm
    • Zollernring 26
    • 89073  Ulm
    • Germany
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    • Malteser Krankenhaus Seliger Gerhard Bonn/Rhein-Sieg, Akademisches Lehrkrankenhaus der Universität Bonn
    • Mr.  Priv. Doz. Dr. med.  Albert  Lukas 
    • Von-Hompesch-Strasse 1
    • 53123  Bonn
    • Germany
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    • Malteser Krankenhaus Seliger Gerhard Bonn/Rhein-Sieg, Akademisches Lehrkrankenhaus der Universität Bonn
    • Mr.  Priv. Doz. Dr. med.  Albert  Lukas 
    • Von-Hompesch-Strasse 1
    • 53123  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Robert Bosch Stiftung GmbH
    • Heidenhofstrasse 31
    • 70184  Stuttgart
    • Germany
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    • Mundipharma GmbH
    • Mundipharma Strasse 2
    • 65549  Limburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/06/25
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Trial Publications, Results and other Documents

  •   Lukas A, Hagg-Grün U, Mayer B, Fischer T, Schuler M. Pain assessment in advanced dementia. Validity of the German PAINAD-a prospective double-blind randomised placebo-controlled trial. Pain. 2019 Mar;160(3):742-753. doi: 10.1097/j.pain.0000000000001430.
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* This entry means the parameter is not applicable or has not been set.