The Pain in Intensive Care Unit: Different Rating System Comparing (ICPain)

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: CPOT, BPS

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Varese, Italy, 21100
    • Azienda ospedaliera ospedale Circolo e Fondazione Macchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult male and female Critically ill patients Mechanically ventilated patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICU patients; 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.	Other: CPOT, BPS; Scoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Study Director: Paolo MD Severgnini, Prof., Universita' degli Studi dell'Insubria, Varese, Italy

Publications and helpful links

General Publications

• Severgnini P, Pelosi P, Contino E, Serafinelli E, Novario R, Chiaranda M. Accuracy of Critical Care Pain Observation Tool and Behavioral Pain Scale to assess pain in critically ill conscious and unconscious patients: prospective, observational study. J Intensive Care. 2016 Nov 7;4:68. doi: 10.1186/s40560-016-0192-x. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: June 14, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (Estimate): August 21, 2012

Study Record Updates

• Last Update Posted (Estimate): April 23, 2013
• Last Update Submitted That Met QC Criteria: April 22, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Pain; ICU; Mechanical ventilation; BPS; CPOT
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 1514