PainDOLSMURNCT05791253
Pain Management in Primary Intervention of the Mobile Emergency and Resuscitation Service
An observational study of Pain, run by Hôpital NOVO at 1 site in France.
Trial summary
The aim of the study is to carry out an inventory of practices relating to the management of pain: its recognition, assessment and treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Pain management
- How many people
- 365 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2023to 23 Mar 2023
- 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: Patients who received an intervention from the Mobile Emergency and Resuscitation Service (primary intervention) between 01/11 and 30/11/2021, between 01/03 and 31/03/2022 or between 01/08 and 31/08/2022.
Who may be able to join
- Patients over 18 years of age,
- Patient managed on primary intervention file between 01/11 and 30/11/2021, between 01/03 and 31/03/2022 or between 01/08 and 31/08/2022,
- Patient transferred to NOVO hospital (Pontoise, Beaumont-sur-Oise or Magny en Vexin site) for further medical care.
Who cannot join
- Patient in Cardiorespiratory Arrest (CRA),
- Patient in coma,
- Patient without applicant,
- Patient who has expressed his opposition to the collect of his data.
Trial locations and contacts
1 site in 1 country.
France1 site
Mobile Emergency and Resuscitation Unit - NOVO Hospital - Pontoise Site
Pontoise, 95300
About this study
Official title: Pain Management in Adults in Primary Intervention of the Mobile Emergency and Resuscitation Service of Pontoise
The aim of the study is to carry out an inventory of practices relating to the management of pain: its recognition, assessment and treatment.
Read the detailed description
Pain is one of the most frequent reasons for seeking emergency care, with a prevalence of approximately 42% in pre-hospital care.
Pain management practices are defined by the French Society of Anaesthesia and Intensive Care (SFAR) and the French Society of Emergency Medicine (SFMU).
Pain must be systematically managed and treated. To do this, it is necessary to start by assessing the pain using self-assessment scales, the VAS (Visual Analogue Pain Scale) or the EN (Numerical Pain Scale) being the two validated scales.
Depending on the intensity of the pain, appropriate treatments should be prescribed:
- If EN < 6: level I or II analgesic
- If EN > 6: morphine titration Finally, after the treatment has been implemented, the pain must be re-evaluated using the same self-assessment scales in order to attest to the effectiveness of the treatment.
There is a lack of knowledge of the recommendations for pain management and assessment: 49% of SMUR doctors do not know the SFAR recommendations and only 17% define severe acute pain by a VAS or ENS greater than 6/10.
The aim of the study is to carry out an inventory of practices relating to the management of pain: its recognition, assessment and treatment and to check whether pain management was carried out according to the recommendations of the French Society of Anaesthesia and Intensive Care (SFAR) and the French Society of Emergency Medicine (SFMU).
- Conditions
- Pain
- Being tested
- Pain management
- Keywords
- Pain management, Emergency care, Mobile Emergency and Resuscitation Service
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain managementOther
Check whether pain management was carried out according to the recommendations of the French Society of Anaesthesia and Intensive Care (SFAR) and the French Society of Emergency Medicine (SFMU)
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain management according to the recommendations of the SFAR and SFMU
The the recommendations of the SFAR and SFMU about Pain management is based on a composite criterion with the following items:
- Pain recognition and assessment EN (Numerical scale)
- Implementation of an adapted therapy (prescriptions) according to the pain scale scores
- Re-evaluation of pain EN (Numerical scale)
The evaluation of the objective is based on this composite criterion : for each item, the answer will be Yes or No. The outcom is validate if the answer of each item is yes.
Measured: At the end of the study, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start9 Mar 2023
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Retrospective
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Fancelli, Principal investigator, Hospital NOVO - Pontoise site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791253
- Sponsor's protocol ID
- CHRD 1322
- Acronym
- DOLSMUR
- Status last verified
- May 2023
- First submitted
- 14 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vivien B, Adnet F, Bounes V, Cheron G, Combes X, David JS, Diependaele JF, Eledjam JJ, Eon B, Fontaine JP, Freysz M, Michelet P, Orliaguet G, Puidupin A, Ricard-Hibon A, Riou B, Wiel E, de La Coussaye JE. [Sedation and analgesia in emergency structure. Reactualization 2010 of the Conference of Experts of Sfar of 1999]. Ann Fr Anesth Reanim. 2012 Apr;31(4):391-404. doi: 10.1016/j.annfar.2012.02.006. Epub 2012 Mar 28. No abstract available. French.
PubMed 22459942Galinski M, Ruscev M, Gonzalez G, Kavas J, Ameur L, Biens D, Lapostolle F, Adnet F. Prevalence and management of acute pain in prehospital emergency medicine. Prehosp Emerg Care. 2010 Jul-Sep;14(3):334-9. doi: 10.3109/10903121003760218.
PubMed 20507221Albrecht E, Taffe P, Yersin B, Schoettker P, Decosterd I, Hugli O. Undertreatment of acute pain (oligoanalgesia) and medical practice variation in prehospital analgesia of adult trauma patients: a 10 yr retrospective study. Br J Anaesth. 2013 Jan;110(1):96-106. doi: 10.1093/bja/aes355. Epub 2012 Oct 11.
PubMed 23059961Ricard-Hibon A, Chollet C, Saada S, Loridant B, Marty J. A quality control program for acute pain management in out-of-hospital critical care medicine. Ann Emerg Med. 1999 Dec;34(6):738-44. doi: 10.1016/s0196-0644(99)70099-5.
PubMed 10577403
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management in Adults in Primary Intervention of the Mobile Emergency and Resuscitation Service of Pontoise
- ClinicalTrials.gov ID
- NCT05791253
- Acronym / sponsor ID
- DOLSMUR / CHRD 1322
- Conditions
- Pain
- Keywords
- Pain management, Emergency care, Mobile Emergency and Resuscitation Service
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 30 Mar 2023 (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 aim of the study is to carry out an inventory of practices relating to the management of pain: its recognition, assessment and treatment.
Detailed description
Pain is one of the most frequent reasons for seeking emergency care, with a prevalence of approximately 42% in pre-hospital care.
Pain management practices are defined by the French Society of Anaesthesia and Intensive Care (SFAR) and the French Society of Emergency Medicine (SFMU).
Pain must be systematically managed and treated. To do this, it is necessary to start by assessing the pain using self-assessment scales, the VAS (Visual Analogue Pain Scale) or the EN (Numerical Pain Scale) being the two validated scales.
Depending on the intensity of the pain, appropriate treatments should be prescribed:
- If EN < 6: level I or II analgesic
- If EN > 6: morphine titration Finally, after the treatment has been implemented, the pain must be re-evaluated using the same self-assessment scales in order to attest to the effectiveness of the treatment.
There is a lack of knowledge of the recommendations for pain management and assessment: 49% of SMUR doctors do not know the SFAR recommendations and only 17% define severe acute pain by a VAS or ENS greater than 6/10.
The aim of the study is to carry out an inventory of practices relating to the management of pain: its recognition, assessment and treatment and to check whether pain management was carried out according to the recommendations of the French Society of Anaesthesia and Intensive Care (SFAR) and the French Society of Emergency Medicine (SFMU).
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
- Patients who received an intervention from the Mobile Emergency and Resuscitation Service (primary intervention) between 01/11 and 30/11/2021, between 01/03 and 31/03/2022 or between 01/08 and 31/08/2022.
Key inclusion criteria (3 listed)
- Patients over 18 years of age,
- Patient managed on primary intervention file between 01/11 and 30/11/2021, between 01/03 and 31/03/2022 or between 01/08 and 31/08/2022,
- Patient transferred to NOVO hospital (Pontoise, Beaumont-sur-Oise or Magny en Vexin site) for further medical care.
Key exclusion criteria (4 listed)
- Patient in Cardiorespiratory Arrest (CRA),
- Patient in coma,
- Patient without applicant,
- Patient who has expressed his opposition to the collect of his data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain managementCheck whether pain management was carried out according to the recommendations of the French Society of Anaesthesia and Intensive Care (SFAR) and the French Society of Emergency Medicine (SFMU) | Other | – |
Primary outcome
Evaluation of pain management according to the recommendations of the SFAR and SFMU
Time frame: At the end of the study, an average of one month
The the recommendations of the SFAR and SFMU about Pain management is based on a composite criterion with the following items: * Pain recognition and assessment EN (Numerical scale) * Implementation of an adapted therapy (prescriptions) according to the pain scale scores * Re-evaluation of pain EN (Numerical scale) The evaluation of the objective is based on this composite criterion : for each item, the answer will be Yes or No. The outcom is validate if the answer of each item is yes.
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 19 Sep 2024.
- Background: PubMed 22459942Vivien B, Adnet F, Bounes V, Cheron G, Combes X, David JS, Diependaele JF, Eledjam JJ, Eon B, Fontaine JP, Freysz M, Michelet P, Orliaguet G, Puidupin A, Ricard-Hibon A, Riou B, Wiel E, de La Coussaye JE. [Sedation and analgesia in emergency structure. Reactualization 2010 of the Conference of Experts of Sfar of 1999]. Ann Fr Anesth Reanim. 2012 Apr;31(4):391-404. doi: 10.1016/j.annfar.2012.02.006. Epub 2012 Mar 28. No abstract available. French.
- Background: PubMed 20507221Galinski M, Ruscev M, Gonzalez G, Kavas J, Ameur L, Biens D, Lapostolle F, Adnet F. Prevalence and management of acute pain in prehospital emergency medicine. Prehosp Emerg Care. 2010 Jul-Sep;14(3):334-9. doi: 10.3109/10903121003760218.
- Background: PubMed 23059961Albrecht E, Taffe P, Yersin B, Schoettker P, Decosterd I, Hugli O. Undertreatment of acute pain (oligoanalgesia) and medical practice variation in prehospital analgesia of adult trauma patients: a 10 yr retrospective study. Br J Anaesth. 2013 Jan;110(1):96-106. doi: 10.1093/bja/aes355. Epub 2012 Oct 11.
- Background: PubMed 10577403Ricard-Hibon A, Chollet C, Saada S, Loridant B, Marty J. A quality control program for acute pain management in out-of-hospital critical care medicine. Ann Emerg Med. 1999 Dec;34(6):738-44. doi: 10.1016/s0196-0644(99)70099-5.
- 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.
Olivier Fancelli principal investigator
Hospital NOVO - Pontoise site
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 Hôpital NOVO 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 3 inclusion and 4 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 19 Sep 2024. 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?
Evaluation of pain management according to the recommendations of the SFAR and SFMU (time frame: At the end of the study, an average of one month). 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 NCT05791253, which also lists 4 linked publications.
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 19 Sep 2024.