EMERGENCY MEDICINECHROPAINNCT04625374
Prevalence of Chronic Pain After an Emergency Department Visit for Severe Acute Pain
An observational study of EMERGENCY MEDICINE, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
The main objective for investigators is to determine the prevalence of moderate to severe chronic pain in the adult population 6 months after consultation in the emergency department for acute pain (less than 7 days old) and severe pain assessed at admission and defined as greater than or equal to 6/10 by the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EMERGENCY MEDICINE
- How many people
- 495 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Dec 2020to 1 Mar 2022
- 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: Patient who have consulted in the emergency department between 4 to 5 months before reading the files to be contacted 6 months after the consultation in the emergency department
Who may be able to join
- To have consulted in the emergency department between 4 to 5 months before reading the files to be contacted 6 months after the consultation in the emergency department;
- Initial pain ≥6 on the Numerical Pain Scale ;
- Acute pain that has been evolving for less than 7 days.
- No oral opposition of the subject required during the phone call
Who cannot join
- Patient who has undergone surgery in the direct course or within one month of the emergency department visit;
- Patient with suspected or confirmed coronary chest pain at the time of discharge from the emergency department;
- Patient with a mental disability;
- Patient dead;
- Patient who is deaf or hard of hearing;
- Patient who does not speak French or does not live in France
Show all 15Show fewer
- Patient whose medical history was noted in the file as being impossible due to communication problems;
- Patient who left the emergency department before the end of medical care;
- Patient consulting for acutization of chronic pain;
- Patient during pregnancy;
- Patient consulting for a recent complication of care (within the month), surgical or other;
- Patient taking daily analgesic treatments in the last 2 months;
- Patient known to be dependent on opioids or treated with substitution therapy;
- Homeless patient;
- Patient who has been injured in the course of an assault or violence.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Pellegrin
Bordeaux, 33000
Grenoble Alpes University Hospital
Grenoble, 38000
About this study
Official title: Prevalence of Chronic Pain After an Emergency Department Visit for Severe Acute Pain and Influence of the Analgesia Initially Used
The main objective for investigators is to determine the prevalence of moderate to severe chronic pain in the adult population 6 months after consultation in the emergency department for acute pain (less than 7 days old) and severe pain assessed at admission and defined as greater than or equal to 6/10 by the numerical pain scale.
Read the detailed description
The presence of pain is the most frequent reason for a patient to visit the emergency department. the investigators know that severe acute pain can be a risk factor for developing chronic pain.
Chronic pain is a symptom, devoid of biological utility, that persists despite the absence of nociceptive stimulus, even after a reasonable period of time that would have allowed the tissue lesion to heal. It is therefore a public health problem with a negative impact on patients' lives.
Chronic pain has been studied in anesthesia and surgery in recent years. In 2006, a study showed the appearance of chronic pain (incidence between 10-50%) in patients who had undergone routine surgery. On the other hand, few studies have looked at the occurrence of chronic pain in patients who came to the emergency department for acute pain.
It is in this context that the investigators find it relevant to assess the prevalence of moderate to severe chronic pain after an emergency department consultation for severe acute pain.
The physiological mechanisms of pain are better identified and the activation of N-methyl-D-aspartate (NMDA) receptors contributes to the onset of hyperalgesia. These receptors are activated under certain conditions, such as during intense and prolonged pain or exposure to high doses of opioids. In addition, the hyperalgesic effect of opioids is known and widely described in the literature. Finally, in the perioperative period, it is now accepted that the administration of a low dose of ketamine can combat these hyperalgesic effects thanks to its NMDA receptor inhibitory action. This effect may have an impact on pain at six months after surgery.
On the basis of these data, it seems relevant to question the prevalence of chronic pain in the course of an emergency department consultation, all the more so in patients with severe initial pain, in whom there is an initial indication for morphine titration, based on the recommendations of the French Society of Emergency Medicine (SFMU).
In addition, the investigators need to question the effects of initial analgesia administered in the emergency department for patients with severe acute pain. Is there a link between the use of certain molecules or the combination of molecules on the onset of chronic pain?
- Conditions
- EMERGENCY MEDICINE
- Keywords
- prevalence chronic pain, emergency department, severe acute pain, initial analgesia
- Medical subject headings
- Emergencies, Acute Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine prevalence of moderate to severe chronic pain in adult population 6 months after consultation in the emergency department for acute pain (less than 7 days old) and severe pain assessed at admission (defined ≥6/10 by the numerical pain scale)
The main judgment criteria is the presence of chronic pain, related to the pain that motivated the emergency department visit 6 months earlier, moderate to severe defined as pain evolving since the emergency department visit (6 months), experienced at least 2 times per week, and of intensity ≥ 4 on a numerical pain scale during the patient's last painful experience.
Measured: 6 month
Secondary outcomes (10)
To compare the prevalence of chronic pain in patients who initially consulted for pain of traumatic or non-traumatic origin.
Compare the prevalence of moderate to severe chronic pain (defined in the primary end point ≥4/10) in the group of patients who initially consulted for pain from traumatic and nontraumatic causes. Traumatic pain is defined as pain related to a traumatic mechanism less than 1 week old.
Measured: 6 month
Evaluate whether there is an association between the prevalence of chronic pain at 6 months and pain management in use of analgesic, which molecule when the patient goes to the emergency department ;
Association between the prevalence of chronic pain and pain management in the emergency department at analgesic treatment used per molecule
Measured: 6 month
Evaluate whether there is an association between the prevalence of chronic pain at 6 months and pain management in use of analgesic at which dose when the patient goes to the emergency department ;
Association between the prevalence of chronic pain and pain management in the emergency department at the total dose administered to the emergency department
Measured: 6 month
Evaluate whether there is an association between the prevalence of chronic pain at 6 months and pain management at the performance of a locoregional anaesthesia when the patient goes to the emergency department ;
Association between the prevalence of chronic pain and pain management in the emergency department in the realization of a locoregional anaesthesia
Measured: 6 month
Evaluate whether there is an association between the prevalence of chronic pain at 6 months and pain management at the performance of sedation when the patient goes to the emergency department ;
Association between the prevalence of chronic pain and pain management in the emergency department in the performance of procedural sedation
Measured: 6 month
If patients with chronic pain at 6 months reconstructed more often than patients without chronic pain
We will assess whether patients with chronic pain at 6 months reconstruct more often than patients without chronic pain by asking them whether or not they consulted a list of medical specialists, paramedics or did other tests.
Measured: 6 month
The type, characteristics and impact of pain at 6 months after admission to the emergency department.
Brief Pain Inventory Short Form (BPI-SF) questionnaire, 6 months after their visit to the emergency department.
Measured: 6 month
Neuropathic characteristics of pain at 6 months
The neuropathic characteristics of pain will be characterized by the DN-4 questionnaire
Measured: 6 month
Quality of life 6 months after admission to the emergency department
The SF-12 questionnaire will assess quality of life 6 months after admission to the emergency department
Measured: 6 month
Analgesic treatment at 6 months.
Analgesic treatment at 6 months will be evaluated by asking the patient his usual analgesic treatment by class of molecule
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start5 Dec 2020
- Primary completion1 Sep 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EMERGENCY MEDICINEStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625374
- Sponsor's protocol ID
- 38RC20.293
- Other IDs
- 2020-A02317-32
- Acronym
- CHROPAIN
- Status last verified
- May 2022
- First submitted
- 5 Nov 2020
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chronic Pain After an Emergency Department Visit for Severe Acute Pain and Influence of the Analgesia Initially Used
- ClinicalTrials.gov ID
- NCT04625374
- Acronym / sponsor ID
- CHROPAIN / 38RC20.293
- Conditions
- EMERGENCY MEDICINE
- Keywords
- prevalence chronic pain, emergency department, severe acute pain, initial analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 5 Dec 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 12 Nov 2020 (actual)
- 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.
The main objective for investigators is to determine the prevalence of moderate to severe chronic pain in the adult population 6 months after consultation in the emergency department for acute pain (less than 7 days old) and severe pain assessed at admission and defined as greater than or equal to 6/10 by the numerical pain scale.
Detailed description
The presence of pain is the most frequent reason for a patient to visit the emergency department. the investigators know that severe acute pain can be a risk factor for developing chronic pain.
Chronic pain is a symptom, devoid of biological utility, that persists despite the absence of nociceptive stimulus, even after a reasonable period of time that would have allowed the tissue lesion to heal. It is therefore a public health problem with a negative impact on patients' lives.
Chronic pain has been studied in anesthesia and surgery in recent years. In 2006, a study showed the appearance of chronic pain (incidence between 10-50%) in patients who had undergone routine surgery. On the other hand, few studies have looked at the occurrence of chronic pain in patients who came to the emergency department for acute pain.
It is in this context that the investigators find it relevant to assess the prevalence of moderate to severe chronic pain after an emergency department consultation for severe acute pain.
The physiological mechanisms of pain are better identified and the activation of N-methyl-D-aspartate (NMDA) receptors contributes to the onset of hyperalgesia. These receptors are activated under certain conditions, such as during intense and prolonged pain or exposure to high doses of opioids. In addition, the hyperalgesic effect of opioids is known and widely described in the literature. Finally, in the perioperative period, it is now accepted that the administration of a low dose of ketamine can combat these hyperalgesic effects thanks to its NMDA receptor inhibitory action. This effect may have an impact on pain at six months after surgery.
On the basis of these data, it seems relevant to question the prevalence of chronic pain in the course of an emergency department consultation, all the more so in patients with severe initial pain, in whom there is an initial indication for morphine titration, based on the recommendations of the French Society of Emergency Medicine (SFMU).
In addition, the investigators need to question the effects of initial analgesia administered in the emergency department for patients with severe acute pain. Is there a link between the use of certain molecules or the combination of molecules on the onset of chronic pain?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who have consulted in the emergency department between 4 to 5 months before reading the files to be contacted 6 months after the consultation in the emergency department
Key inclusion criteria (4 listed)
- To have consulted in the emergency department between 4 to 5 months before reading the files to be contacted 6 months after the consultation in the emergency department;
- Initial pain ≥6 on the Numerical Pain Scale ;
- Acute pain that has been evolving for less than 7 days.
- No oral opposition of the subject required during the phone call
Key exclusion criteria (15 listed)
- Patient who has undergone surgery in the direct course or within one month of the emergency department visit;
- Patient with suspected or confirmed coronary chest pain at the time of discharge from the emergency department;
- Patient with a mental disability;
- Patient dead;
- Patient who is deaf or hard of hearing;
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
Determine prevalence of moderate to severe chronic pain in adult population 6 months after consultation in the emergency department for acute pain (less than 7 days old) and severe pain assessed at admission (defined ≥6/10 by the numerical pain scale)
Time frame: 6 month
The main judgment criteria is the presence of chronic pain, related to the pain that motivated the emergency department visit 6 months earlier, moderate to severe defined as pain evolving since the emergency department visit (6 months), experienced at least 2 times per week, and of intensity ≥ 4 on a numerical pain scale during the patient's last painful experience.
10 secondary outcomes
To compare the prevalence of chronic pain in patients who initially consulted for pain of traumatic or non-traumatic origin.
Time frame: 6 month
Evaluate whether there is an association between the prevalence of chronic pain at 6 months and pain management in use of analgesic, which molecule when the patient goes to the emergency department ;
Time frame: 6 month
Evaluate whether there is an association between the prevalence of chronic pain at 6 months and pain management in use of analgesic at which dose when the patient goes to the emergency department ;
Time frame: 6 month
Evaluate whether there is an association between the prevalence of chronic pain at 6 months and pain management at the performance of a locoregional anaesthesia when the patient goes to the emergency department ;
Time frame: 6 month
Evaluate whether there is an association between the prevalence of chronic pain at 6 months and pain management at the performance of sedation when the patient goes to the emergency department ;
Time frame: 6 month
If patients with chronic pain at 6 months reconstructed more often than patients without chronic pain
Time frame: 6 month
The type, characteristics and impact of pain at 6 months after admission to the emergency department.
Time frame: 6 month
Neuropathic characteristics of pain at 6 months
Time frame: 6 month
Quality of life 6 months after admission to the emergency department
Time frame: 6 month
Analgesic treatment at 6 months.
Time frame: 6 month
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 24 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EMERGENCY MEDICINE, run by University Hospital, Grenoble at 2 sites 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 15 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 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Determine prevalence of moderate to severe chronic pain in adult population 6 months after consultation in the emergency department for acute pain (less than 7 days old) and severe pain assessed at admission (defined ≥6/10 by the numerical pain scale) (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2022.