Pain Assessment in the Intensive Care Unit

NCT01628185 | Completed

• 1 other identifier: 11-0691
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• pain score validity

  change from time 0 pain assessment to time 30min pain assessment

Study Arms (1)

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

Interventions

Repositioning PROCEDURE

pain assessment at baseline then following routine care repositioning in bed

Pain Observations

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Intensive Care Unit patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related 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.

  PMID: 25063269 BACKGROUND

MeSH Terms

Conditions

Delirium; Critical Illness

Condition Hierarchy (Ancestors)

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

Study Officials

• Jesse Hall, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: June 26, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

US (1)