- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03499301
Description of Chronic Pain in Emergencies Room and Medical Care Modalities (CHRODOLURG)
June 24, 2020 updated by: University Hospital, Bordeaux
The rate of patients with chronic pain (CP) is 40% in patients with acute pain in emergency department (ED).
Patients with CP come more frequently to ED than patients without CP.
Reasons for their visit to ED are often in relation with this CP.
Few studies have been interested to management modalities of these patients in ED.
The investigators are going to realize a prospective observational study in one center.
The hypothesis is that patients with chronic pain are less satisfied of ED management that patients without CP.
Study Overview
Status
Completed
Conditions
Detailed Description
Chronic pain is defined by a daily pain since more than 3 months.
CP is different of acute pain because of their mechanisms, treatments and therapeutic objectives.
CP is associated with an alteration of quality of life with psychological, social and economic consequences.
The prevalence of CP in France is 15%.
In ED, the rate of CP in patients with acute pain was around 40%.
Patients with CP come more frequently to ED than patients without CP.
Their use of care structures, particularly ED, is all the more frequent that their disability is important.
The satisfaction of these patients in ED is associated with age, nature of pain, wait duration, realisation of imaging, and administration of painkillers and relieving of pain.
The reasons why these patients go to ED were pain exacerbation, inadequate strategy of coping, severity of disease and sometime despair associated with stress or anxiety.
Currently the investigators do not know if these managements in ED are adequate or not.
And finally the investigators do not know whether the satisfaction about their ED management is different from patients without CP.
The investigators are going to collect data about all patients admitted in ED with the objective to compare the satisfaction between patients with CP and patients without CP.
The follow up will be restricted to the area of ED.
The last data will be collected just before the exit from ED.
Study Type
Observational
Enrollment (Actual)
292
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bordeaux, France, 33000
- Hôpital Pellegrin - Service des urgences adultes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study concerns emergency department population.
Description
Inclusion Criteria:
- 18 years old or more admitted in ED
- between 8 am and 5pm
- from Monday to Friday.
Exclusion Criteria:
- Patients admitted directly in emergency intensive care for vital distress defined by hemodynamic, respiratory, or neurological failure distress,
- multitrauma patients;
- patient without possibility to communicate because of neurologic disease or mental status disease;
- linguistic barrier.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Chronic pain
Patients with chronic pain when arrived to emergency room.
|
No chronic pain
Patients without chronic pain when arrived to emergency room.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medical care modalities satisfaction
Time Frame: Day 1
|
Proportion of patients satisfied or very satisfied with the management at the emergency department (ED)
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of patients with chronic pain.
Time Frame: Day 1
|
History of a chronic pain or daily pain since 3 months.
|
Day 1
|
Duration of management between first medical contact and delivery from ED.
Time Frame: Day 1
|
Time on arrival at the ED and time on discharge from ED.
|
Day 1
|
Pain intensity
Time Frame: Day 1
|
Measurement with numerical pain scale, from 0 (without pain) to 10 (the worst pain intensity imaginable).
|
Day 1
|
Anxiety intensity
Time Frame: Day 1
|
Measurement with numerical anxiety scale, from 0 (without anxiety) to 10 (the worst anxiety intensity imaginable).
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2018
Primary Completion (Actual)
February 3, 2018
Study Completion (Actual)
February 3, 2018
Study Registration Dates
First Submitted
March 20, 2018
First Submitted That Met QC Criteria
April 13, 2018
First Posted (Actual)
April 17, 2018
Study Record Updates
Last Update Posted (Actual)
June 25, 2020
Last Update Submitted That Met QC Criteria
June 24, 2020
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2017/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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