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Completed

NCT Number: NCT01669486

The Pain in Intensive Care Unit: Different Rating System Comparing

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.

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Key information

Conditions

Critical Illness Disease Attributes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda ospedaliera ospedale Circolo e Fondazione Macchi

Varese, 21100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CPOT, BPS

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study title

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

Acronym: ICPain

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 21, 2012
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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