Pain Assessment in the Intensive Care Unit

Critical Illness Clinical Trial

Official title:

Pain Assessment in the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628185
• Other study ID #: 11-0691
• Status: Completed
• Phase: N/A
• First received: February 23, 2012
• Last updated: December 16, 2015
• Start date: January 2012
• Est. completion date: July 2014

Study information

• Verified date: December 2015
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Delirium

Intervention

Procedure:
• Repositioning
pain assessment at baseline then following routine care repositioning in bed

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chanques G, Pohlman A, Kress JP, Molinari N, de Jong A, Jaber S, Hall JB. Psychometric comparison of three behavioural scales for the assessment of pain in critically ill patients unable to self-report. Crit Care. 2014 Jul 25;18(5):R160. doi: 10.1186/cc14000. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score reliability	Behavioral Pain Scale(BPS), Critical Care Pain Observation Tool (CPOT), Non Verbal Pain Scale (NVPS)	change from time 0 pain assessment to time 30min pain assessment	No
Secondary	pain score validity	Behavioral Pain Scale(BPS), Critical Care Pain Observation Tool (CPOT), Non Verbal Pain Scale (NVPS)	change from time 0 pain assessment to time 30min pain assessment	No