The Pain in Intensive Care Unit: Different Rating System Comparing

NCT ID: NCT01669486

Last Updated: 2013-04-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-04-30

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.

Conditions

Critical Illness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

CPOT, BPS

Intervention Type: OTHER

Scoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers.

Interventions

CPOT, BPS

Scoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi dell'Insubria

OTHER

Sponsor Role: lead

Responsible Party

Paolo Severgnini

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo MD Severgnini, Prof.

Role: STUDY_DIRECTOR

Universita' degli Studi dell'Insubria, Varese, Italy

Locations

Azienda ospedaliera ospedale Circolo e Fondazione Macchi

Varese, Varese, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 27833752 (View on PubMed)

Other Identifiers

1514

Identifier Type: -

Identifier Source: org_study_id