Pain Assessment in the Intensive Care Unit

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01628185
First received: February 23, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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
Delirium
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Behavioral Pain Scale(BPS), Critical Care Pain Observation Tool (CPOT), Non Verbal Pain Scale (NVPS)


Estimated Enrollment: 85
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 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
Other Name: Repositioning

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Intensive Care Unit patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628185

Contacts
Contact: Anne Pohlman, MSN 773-702-3804 apohlman@medicine.bsd.uchicago.edu
Contact: Jesse Hall, MD 773-702-1454 jhall@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Anne Pohlman, MSN    773-702-3804    apohlman@medicine.bsd.uchicago.edu   
Contact: Jesse Hall, MD    773-702-1454    jhall@medicine.bsd.uchicago.edu   
Principal Investigator: Jesse Hall, MD         
Sub-Investigator: Shruti Patel, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jesse Hall, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01628185     History of Changes
Other Study ID Numbers: 11-0691
Study First Received: February 23, 2012
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Critical Illness
Delirium
Disease Attributes
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014