PainEuropain®NCT01070082
Europain®: A Study of Procedural Pain
An observational study of Pain, run by Saint-Louis Hospital, Paris, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 5,150 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Associated With ICU Procedures: An International Study
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.
Read more
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.
Read the 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
- Keywords
- adult ICU patients, procedural pain, pain intensity, pain distress, pain behaviors, pain, ICU procedures
- Medical subject headings
- Pain, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult ICU patients undergoing procedure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Louis Hospital, Paris, France
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Investigators
- kathleen Puntillo, RN DNSc FAAN, Principal investigator, Medical ICU, Saint-Louis Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070082
- Sponsor's protocol ID
- 09-066
- Acronym
- Europain®
- Status last verified
- Apr 2010
- First submitted
- 16 Feb 2010
- Last updated
- 18 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24262016
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Associated With ICU Procedures: An International Study
- ClinicalTrials.gov ID
- NCT01070082
- Acronym / sponsor ID
- Europain® / 09-066
- Conditions
- Pain
- Keywords
- adult ICU patients, procedural pain, pain intensity, pain distress, pain behaviors, pain, ICU procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,150 participants (actual)
- Lead sponsor
- Saint-Louis Hospital, Paris, FranceUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult ICU patients undergoing procedure | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain intensity
Time frame: 1 minute
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2011.
- Derived from this study: PubMed 24262016Puntillo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kathleen Puntillo, RN DNSc FAAN principal investigator
Medical ICU, Saint-Louis Hospital, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Saint-Louis Hospital, Paris, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 1 minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01070082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2011.