Europain®: A Study of Procedural Pain

NCT ID: NCT01070082

Last Updated: 2011-08-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-12-31

Brief 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.

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)

Conditions

Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult ICU patients undergoing procedure

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Society of Intensive Care Medicine

OTHER

Sponsor Role: collaborator

Saint-Louis Hospital, Paris, France

OTHER

Sponsor Role: lead

Responsible Party

Medical ICU, Saint-Louis Hospital, Paris, France

Principal Investigators

kathleen Puntillo, RN DNSc FAAN

Role: PRINCIPAL_INVESTIGATOR

Medical ICU, Saint-Louis Hospital, Paris, France

Locations

Medical ICU, Saint-Louis Hospital

Paris, , France

Countries

France

References

Puntillo KA, Max A, Timsit JF, Vignoud L, Chanques G, Robleda G, Roche-Campo F, Mancebo J, Divatia JV, Soares M, Ionescu DC, Grintescu IM, Vasiliu IL, Maggiore SM, Rusinova K, Owczuk R, Egerod I, Papathanassoglou ED, Kyranou M, Joynt GM, Burghi G, Freebairn RC, Ho KM, Kaarlola A, Gerritsen RT, Kesecioglu J, Sulaj MM, Norrenberg M, Benoit DD, Seha MS, Hennein A, Periera FJ, Benbenishty JS, Abroug F, Aquilina A, Monte JR, An Y, Azoulay E. Determinants of procedural pain intensity in the intensive care unit. The Europain(R) study. Am J Respir Crit Care Med. 2014 Jan 1;189(1):39-47. doi: 10.1164/rccm.201306-1174OC.

Reference Type: DERIVED

PMID: 24262016 (View on PubMed)

Other Identifiers

09-066

Identifier Type: -

Identifier Source: org_study_id