Pain Assessment in the Intensive Care Unit

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01628185

Enrollment

Registered

2012-06-26

Start date

2012-01-31

Completion date

2014-07-31

Last updated

2015-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Delirium

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

Interventions

PROCEDURERepositioning

pain assessment at baseline then following routine care repositioning in bed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026