Europain®: A Study of Procedural Pain

Pain Clinical Trial

— Europain®  

Official title:

Pain Associated With ICU Procedures: An International Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070082
• Other study ID #: 09-066
• Status: Completed
• Phase: N/A
• First received: February 16, 2010
• Last updated: August 17, 2011
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: Saint-Louis Hospital, Paris, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5150
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
France	Medical ICU, Saint-Louis Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Saint-Louis Hospital, Paris, France	European Society of Intensive Care Medicine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity will be measured through the use of a 0 -10 numeric rating scale (NRS), with higher numbers meaning greater pain intensity.	1 minute	No
Primary	Pain Distress	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.	1 minute	No
Primary	Pain Behaviors	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.	1 minute	No