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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669486
First Posted: August 21, 2012
Last Update Posted: April 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paolo Severgnini, Università degli Studi dell'Insubria
June 14, 2012
August 21, 2012
April 23, 2013
June 2012
March 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01669486 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Pain in Intensive Care Unit: Different Rating System Comparing
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Adult male and female Critically ill patients Mechanically ventilated patients
Critical Illness
Other: CPOT, BPS
Scoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers.
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.
Intervention: Other: CPOT, BPS
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. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2013
March 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01669486
1514
Yes
Not Provided
Not Provided
Paolo Severgnini, Università degli Studi dell'Insubria
Università degli Studi dell'Insubria
Not Provided
Study Director: Paolo MD Severgnini, Prof. Universita' degli Studi dell'Insubria, Varese, Italy
Università degli Studi dell'Insubria
April 2013