The Pain in Intensive Care Unit: Different Rating System Comparing

Completed

• Conditions: Critical Illness
• Interventions: Other: CPOT, BPS

• Registration Number: NCT01669486
• Lead Sponsor: Università degli Studi dell'Insubria

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-21
• Primary Completion: 2013-03
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-22
• Last Update Posted: 2013-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU patients	CPOT, BPS	All patients admitted to ICU for a minimal hospitalization of 24 hours, invasive mechanically ventilated, will be evaluated with CPOT and BPS scores, during nurses work, in particular before and after nurses manoeuvers.

Primary Outcome Measures

Name	Time	Method
The evaluation of pain in critically ill patients	Participants will be followed for 3 days	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

Secondary Outcome Measures

Name	Time	Method
The comparisation beetween the CPOT and the BPS scales	Participants will be followed for 3 days	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).
The comparisation of CPOT and BPS between medical and surgical critically ill patients	Participants will be followed for 3 days	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.

Trial Locations

Locations (1)

Azienda ospedaliera ospedale Circolo e Fondazione Macchi; 🇮🇹 Varese, Italy