Pain Assessment in the Intensive Care Unit

NCT ID: NCT01628185

Last Updated: 2015-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Delirium Critical Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Repositioning

Intervention Type PROCEDURE

pain assessment at baseline then following routine care repositioning in bed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Repositioning

pain assessment at baseline then following routine care repositioning in bed

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jesse Hall, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25063269 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11-0691

Identifier Type: -

Identifier Source: org_study_id