The Pain in Intensive Care Unit: Different Rating System Comparing

Critical Illness Clinical Trial

— ICPain  

Official title:

The Pain in Intensive Care Unit: An Experimental Research to Compare Behavioural Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669486
• Other study ID #: 1514
• Status: Completed
• Phase: N/A
• First received: June 14, 2012
• Last updated: April 22, 2013
• Start date: June 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this research is to find the best system for assessing the pain of critically ill patient in Intensive Care Unit (ICU).

At first the investigators assess the sedation of the patient with the scale sedation-agitation scale (SAS) or the delirium with the confusion assessment method, if the patient is too sedated or delirious the investigators consider him unable to use the Visual Analogic Scale (VAS).

The investigators compare two different scales Critical Care Pain Observation Tool (CPOT) and Behavioural Pain Scale (BPS) which include no verbal items. Each items has been evaluated in three different moments: before, during and after the nurses' care.

The investigators compare the scales between them. Then, every time the investigators value the score of these scales with the self-report of patients with the VAS scale (when it is possible) and finally with the physiological parameters (blood pressure, heart rate and respiratory rate).

In the end, the investigators compare two different classes of patient: the surgical and medical one. The investigators search for some differences in the perception of the pain between these two classes.

Description:

This study has specific aims:

1. to find the best method to evaluate the pain in critically ill patients;

2. to compare the perception of pain analysed trough CPOT and BPS;

3. to compare CPOT and BPS between medical and surgical patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• male and female

• require of Mechanical Ventilation (MV)

• Hospitalization on ICU > 24 hours

Exclusion Criteria:

• Age < 18 years

• Tetraplegic

• Neuromuscolar disease

• Neuromuscolar blocking agents by continuous infusion

• Spontaneous breathing without Mechanical Ventilation (MV)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• CPOT, BPS
Scoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers.

Locations

Country	Name	City	State
Italy	Azienda ospedaliera ospedale Circolo e Fondazione Macchi	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The evaluation of pain in critically ill patients	The measurement of pain with no verbal items of different pain scales: facial expression, movements of the body, muscle tone, compliance of mechanical ventilation, movements of the arms. We'll evaluate the level of pain before and after nurses manoeuvers	Participants will be followed for 3 days	No
Secondary	The comparisation beetween the CPOT and the BPS scales	The comparisation beetween the different items of two scales: CPOT (facial expression, movements of the body, muscle tone, compliance of mechanical ventilation) and BPS (facial expression, movements of the arms, compliance of mechanical ventilation).	Participants will be followed for 3 days	No
Secondary	The comparisation of CPOT and BPS between medical and surgical critically ill patients	We'll measure facial expression, movements of the body, muscle tone, compliance of mechanical ventilation, movements of the arms, according with BPS and CPOT scores in two classes of patient: the surgical and medical critically ill patients.	Participants will be followed for 3 days	No