Europain®: A Study of Procedural Pain

NCT01070082 | Completed

• 1 other identifier: 09-066
• Study Type: observational
• Target: 5,150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

adult ICU patients; procedural pain; pain intensity; pain distress; pain behaviors; pain; ICU procedures

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Adult ICU patients undergoing procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint-Louis Hospital, Paris, France: lead
• European Society of Intensive Care Medicine: collaborator

Study Sites (1)

Medical ICU, Saint-Louis Hospital

Paris, 75010, France

Location

Related Publications (1)

• 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.

  PMID: 24262016 DERIVED

MeSH Terms

Conditions

Pain; Pain, Procedural

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• kathleen Puntillo, RN DNSc FAAN

  Medical ICU, Saint-Louis Hospital, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 18, 2011

Record last verified: 2010-04

Locations

FR (1)