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Completed

NCT Number: NCT01628185

Pain Assessment in the Intensive Care Unit

Pain assessment using self-report scales (Visual Analogue Scale, Numerical Rating Scale), is recommended in the general population, however it is not always possible in patients with altered neurological status such as sedated patients or patients with delirium. Consequently, pain assessment is highly challenging in these ICU patients. This is a prospective observational study assessing 3 behavioral pain scales in the ICU.

The hypothesis of this proposal is that one of the three ICU pain scales has a more important reliability than the others. Such a scale could be recommended to be used to measure pain intensity in ICU patients not able to communicate.

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Key information

Conditions

Delirium Confusion Critical Illness Disease Attributes Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

About this study

The aims of this observational study are to measure and compare the psychometric properties of Behavioral Pain Scale (BPS), Critical Care Pain Observation Tool (CPOT) and Non Verbal Pain Scale (NVPS) at baseline and following repositioning procedure in the ICU

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years
  • not comatose, defined by a Richmond Agitation Sedation Scale (RASS) ≥ -3, i.e. between -3 and +4
  • not able to self-report accurately their pain intensity using a visually enlarged 0-10 numeric rating scale

Exclusion criteria

-neurological deficits (acute or chronic) that prevent observation of the muscle tonus or movement. For example:

  • Quadriplegia
  • Current use of Neuromuscular blocking agents
  • Severe brain injuries

Treatment and study plan

Repositioning

Procedure

pain assessment at baseline then following routine care repositioning in bed

Primary outcomes

  1. pain score reliability

    Time frame: change from time 0 pain assessment to time 30min pain assessment

    Behavioral Pain Scale(BPS), Critical Care Pain Observation Tool (CPOT), Non Verbal Pain Scale (NVPS)

Secondary outcomes

  1. pain score validity

    Time frame: change from time 0 pain assessment to time 30min pain assessment

    Behavioral Pain Scale(BPS), Critical Care Pain Observation Tool (CPOT), Non Verbal Pain Scale (NVPS)

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2012
Registry last updated
Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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