The Pain in Intensive Care Unit: Different Rating System Comparing (ICPain)
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|ClinicalTrials.gov Identifier: NCT01669486|
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : April 23, 2013
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.
|Condition or disease||Intervention/treatment|
|Critical Illness||Other: CPOT, BPS|
This study has specific aims:
- to find the best method to evaluate the pain in critically ill patients;
- to compare the perception of pain analysed trough CPOT and BPS;
- to compare CPOT and BPS between medical and surgical patients.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||The Pain in Intensive Care Unit: An Experimental Research to Compare Behavioural Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT)|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||April 2013|
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.
- The evaluation of pain in critically ill patients [ Time Frame: 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
- The comparisation beetween the CPOT and the BPS scales [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669486
|Azienda ospedaliera ospedale Circolo e Fondazione Macchi|
|Varese, Italy, 21100|
|Study Director:||Paolo MD Severgnini, Prof.||Universita' degli Studi dell'Insubria, Varese, Italy|