Clinical trial NCT01669486: The Pain in Intensive Care Unit: Different Rating System Comparing
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: Pain
ICU
Mechanical ventilation
CPOT
BPS
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male and female Critically ill patients Mechanically ventilated patients

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.

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)

Primary outcomes:
measure: The evaluation of pain in critically ill patients
timeFrame: Participants will be followed for 3 days
Secondary outcomes:
measure: The comparisation beetween the CPOT and the BPS scales
timeFrame: Participants will be followed for 3 days
measure: The comparisation of CPOT and BPS between medical and surgical critically ill patients
timeFrame: Participants will be followed for 3 days
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Azienda ospedaliera ospedale Circolo e Fondazione Macchi
Study officials:
affiliation: Universita' degli Studi dell'Insubria, Varese, Italy
name: Paolo MD Severgnini, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.