Europain®: A Study of Procedural Pain

This study has been completed.
Sponsor:
Collaborator:
European Society of Intensive Care Medicine
Information provided by:
Saint-Louis Hospital, Paris, France
ClinicalTrials.gov Identifier:
NCT01070082
First received: February 16, 2010
Last updated: August 17, 2011
Last verified: April 2010
  Purpose

Pain associated with procedures performed on adult ICU patients is ubiquitous and the subject of research attention.While there is growing evidence about the prevalence, characteristics and measurement of procedural pain in ICUs, most of this evidence has been derived from English-speaking patients in the United States who were able to verbally report the intensity and distress of this pain. Frequently performed procedures include turning,chest tube removal,wound care/wound dressing change,endotracheal suctioning,central catheter insertion(arterial/venous, have been a focus for research. Other potentially painful procedures, including lumbar puncture and physiotherapy,are numerous and have not been systematically studied in adults.

Patients unable to verbally report their pain have not been able to participate in procedural pain studies, which has limited the generalizability of study results to a narrow population of ICU patients.

The Specific Aims of this proposed European-based, international study of ICU patients undergoing selected procedures are to:

  • Describe patient self-reports of pain intensity and distress
  • Describe the behaviors exhibited by patients during a procedure, comparing the behaviors exhibited by those able versus unable to self-report pain intensity and pain distress
  • Examine predictors of amount of pain intensity, behavioral responses, and analgesic use related to procedures such as gender, age, language spoken, country, and type of hospital.

Validated pain intensity, pain distress, and behavioral observation instruments will be methodically translated into the predominant languages spoken in our international study sites; research and training packets similar to those developed in a large, multisite study in the United States will be developed and provided to data collection sites; and data collection will occur over a 6-month period of time. Study data will be analyzed and disseminated at international meetings and in publications.


Condition
Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain Associated With ICU Procedures: An International Study

Further study details as provided by Saint-Louis Hospital, Paris, France:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
    Pain intensity will be measured through the use of a 0 -10 numeric rating scale (NRS), with higher numbers meaning greater pain intensity.

  • Pain Distress [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
    Negative emotional responses to painful stimuli (i.e., distress) can be measured separate from pain intensity. Since pain is defined as an unpleasant sensory and emotional experience, it is expected that patients in this study will be able to report pain distress associated with procedures as well as pain intensity. Pain distress will be measured with a 0-10 NRS, where higher numbers connote a greater degree of distress.

  • Pain Behaviors [ Time Frame: 1 minute ] [ Designated as safety issue: No ]
    Observing behavioral indices of pain is another aspect of measuring pain. When patients are undergoing painful procedures, complex neural interactions from the noxious stimulus cause a behavioral response.


Enrollment: 5150
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adult ICU patients undergoing procedure

Detailed Description:

Procedures to be studied are the following:

  • TURNING (moving side to side in bed)
  • POSITIONING (moving up or down in bed)
  • MOBILIZATION (getting out of bed or chair)
  • RESPIRATORY EXERCISES (cough, deep breathe)
  • PERIPHERAL BLOOD DRAW (insertion of catheter into vein in order to draw out blood)
  • PERIPHERAL IV INSERTION (insertion of catheter into vein in order to give medications or fluids)
  • ARTERIAL LINE INSERTION (insertion of arterial catheter for blood pressure monitoring and arterial blood draws)
  • ENDOTRACHEAL SUCTIONING (insertion of suction catheter into endotracheal tube in order to aspirate secretions)
  • TRACHEAL SUCTIONING (insertion of suction catheter into a tracheostomy in order to aspirate secretions)
  • CHEST TUBE REMOVAL (removal of a tube from the mediastinum or plural space)
  • WOUND DRAIN REMOVAL (removal of a drain from a wound such as a drain inserted during abdominal surgery)
  • WOUND CARE (i.e., cleaning, dressing change)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ICU patients who are undergoing any of the study procedures and consent to participate. Adults age 18 and over will be eligible for the study if they meet study inclusion criteria and don't meet any exclusion criteria.

Criteria

Inclusion Criteria:

  • Patient must be 18 years of age or older
  • Patient's primary language is of the country where the evaluation is performed
  • Patient meets IRB/Central EC requirements of the institution/ country where the evaluation is performed
  • Patient is receiving one of the study's procedures as part of standard care

Exclusion Criteria:

  • Patient's condition is very unstable at this time
  • Patient is receiving neuromuscular blocking medications
  • Patient has a disease or condition, such as Guillain-Barre, that alters sensory transmission proximal to procedure site
  • Patient has a disease or condition that would confuse the behavioural assessment, such as decerebrate posturing
  • Patient is, or probably is, delirious
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070082

Locations
France
Medical ICU, Saint-Louis Hospital
Paris, France, 75010
Sponsors and Collaborators
Saint-Louis Hospital, Paris, France
European Society of Intensive Care Medicine
Investigators
Principal Investigator: kathleen Puntillo, RN DNSc FAAN Medical ICU, Saint-Louis Hospital, Paris, France
  More Information

No publications provided by Saint-Louis Hospital, Paris, France

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Kathleen Puntillo, Medical ICU, Saint-Louis Hospital, Paris, France
ClinicalTrials.gov Identifier: NCT01070082     History of Changes
Other Study ID Numbers: 09-066
Study First Received: February 16, 2010
Last Updated: August 17, 2011
Health Authority: France: Institutional Ethical Committee

Keywords provided by Saint-Louis Hospital, Paris, France:
adult ICU patients
procedural pain
pain intensity
pain distress
pain behaviors
pain
ICU procedures

ClinicalTrials.gov processed this record on August 19, 2014