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Pain Assessment in the Intensive Care Unit

This study has been completed.
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: February 23, 2012
Last updated: December 16, 2015
Last verified: December 2015

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.

Condition Intervention
Critical Illness
Procedure: Repositioning

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain Assessment in the Intensive Care Unit

Resource links provided by NLM:

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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)

Enrollment: 30
Study Start Date: January 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pain Observations
Adult ICU patients who are not comatose with Richmond Agitation-Sedation Scale (RASS) score of -3 to 4 and unable to self-report pain. Patients will be excluded for neurological deficits (acute or chronic) that prevent observation of the muscle tonus or movement
Procedure: Repositioning
pain assessment at baseline then following routine care repositioning in bed

Detailed Description:
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

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Intensive Care Unit patients

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
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Please refer to this study by its identifier: NCT01628185

United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Jesse Hall, MD University of Chicago
  More Information

Responsible Party: University of Chicago Identifier: NCT01628185     History of Changes
Other Study ID Numbers: 11-0691
Study First Received: February 23, 2012
Last Updated: December 16, 2015

Additional relevant MeSH terms:
Critical Illness
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes processed this record on May 25, 2017