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Europain®: A Study of Procedural Pain

NCT01070082 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5150

Last updated 2011-08-18

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • European Society of Intensive Care Medicine

    collaborator OTHER

  • Saint-Louis Hospital, Paris, France

    lead OTHER

Principal Investigators

  • kathleen Puntillo, RN DNSc FAAN · Medical ICU, Saint-Louis Hospital, Paris, France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01070082 on ClinicalTrials.gov