PainDASAUNCT02973568
Comparative Study on Acute Pain Evaluation Between Spanish and French Hospital Emergency Unit
An observational study of Pain and EMERGENCY MEDICINE, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Today, pain is a difficult affordable subject in Spain. There are however 187 units of pain care with a consultations rate in emergency center of more than 60%.For example OXYCODONE(opioid analgesic)is widely used while it's under used in Spain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, EMERGENCY MEDICINE
- What is being tested?
- Observational Study
- How many people
- 641 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2016to 15 Jul 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Evety patient admitted in emergency center during 1 month for acute pain and who need treatment for pain
Who may be able to join
- Patient admitted in emergency center for acute pain.
- Patient who accept to participate.
Who cannot join
- Refusal of patient to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Today, pain is a difficult affordable subject in Spain. There are however 187 units of pain care with a consultations rate in emergency center of more than 60%.For example OXYCODONE(opioid analgesic)is widely used while it's under used in Spain.
In the same way MEOPA(Kalinox) is a new approach of pain care daily used as well in France (for example in dislocated shoulder pain, or ulceration care...etc) There are lots of studies relative to chronic pain but not too much about acute pain in Spain.That's why we want to focus our study on evaluation of acute pain treatment and efficacy in french and spanish hospital
- Conditions
- Pain, EMERGENCY MEDICINE
- Being tested
- Observational Study
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
pain VAS (visual analogic scale)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study start1 Apr 2016
- Primary completion31 Dec 2016
- Study completion15 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario de Canarias
- Responsible party
- Sponsor
- Investigators
- Jonay PERERA GIL, PhD student, Study director, Groupe Hospitalier Paris Saint-Joseph (FRANCE)Olivier GANANSIA, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973568
- Sponsor's protocol ID
- DASAU
- Acronym
- DASAU
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on Acute Pain Evaluation Between Spanish and French Hospital Emergency Unit
- ClinicalTrials.gov ID
- NCT02973568
- Acronym / sponsor ID
- DASAU / DASAU
- Conditions
- Pain, EMERGENCY MEDICINE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 641 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Collaborators
- Hospital Universitario de Canarias
- Study start
- 1 Apr 2016
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 25 Nov 2016 (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.
Today, pain is a difficult affordable subject in Spain. There are however 187 units of pain care with a consultations rate in emergency center of more than 60%.For example OXYCODONE(opioid analgesic)is widely used while it's under used in Spain.
In the same way MEOPA(Kalinox) is a new approach of pain care daily used as well in France (for example in dislocated shoulder pain, or ulceration care...etc) There are lots of studies relative to chronic pain but not too much about acute pain in Spain.That's why we want to focus our study on evaluation of acute pain treatment and efficacy in french and spanish hospital
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Evety patient admitted in emergency center during 1 month for acute pain and who need treatment for pain
Key inclusion criteria (2 listed)
- Patient admitted in emergency center for acute pain.
- Patient who accept to participate.
Key exclusion criteria (1 listed)
- Refusal of patient to participate
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 |
|---|---|---|
| Observational Study | Other | – |
Primary outcome
pain VAS (visual analogic scale)
Time frame: 1 hour
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 8 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
Jonay PERERA GIL, PhD student study director
Groupe Hospitalier Paris Saint-Joseph (FRANCE)
Olivier GANANSIA, MD principal investigator
Fondation Hôpital Saint-Joseph
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 and EMERGENCY MEDICINE, run by Fondation Hôpital Saint-Joseph 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 2 inclusion and 1 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 8 Sep 2017. 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 VAS (visual analogic scale) (time frame: 1 hour). 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 8 Sep 2017.