Pain Assessment in the Intensive Care Unit

Completed

• Conditions: Delirium; Critical Illness
• Interventions: Procedure: Repositioning

• Registration Number: NCT01628185
• Lead Sponsor: University of Chicago

Brief Summary

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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-26
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-16
• Last Update Posted: 2015-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pain Observations	Repositioning	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

Primary Outcome Measures

Name	Time	Method
pain score reliability	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

Name	Time	Method
pain score validity	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)

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States