PainSTARTNCT03380247
Multimodal Oral Analgesia for Trauma in the Emergency Department
An observational study of Pain, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The prevalence of pain in the emergency department is estimated between 60% and 78%. However, many studies reported oligo analgesia in about half of patient admitted to the emergency department. The delay before effective analgesia is one of the main causes of oligoanalgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2017to 6 Jul 2018
- 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 admitted at the emergency for non-multiple trauma pain
Who may be able to join
- Adult patients : ≥ 18 year and older
- Trauma pain
- NRS≥ 4
- Non- opposition to participate in the study
Who cannot join
- Trauma with at least one of the following severity criteria:
- Suspected (from mechanism) or confirmed multiple trauma
- State of shock
- Suspected or proven trauma to the thorax (excluding isolated rib fractures with Spo2 ≥ 98%)
- Suspected or proven Abdominal trauma
- Suspected or proven pelvic trauma
Show all 16Show fewer
- Severe traumatic brain injury
- Altered level of consciousness (Glasgow score < 15)
- Patients who took any analgesic within 4 hours prior to admission (except paracetamol)
- Use of nitrous oxide in the hour before admission
- Patient requiring an intravenous access at admission (e.g. : open fracture displaced)
- Hypersensitivity to one of the molecules of the analgesia protocol
- Known pregnant or likely to be pregnant women at the time of inclusion
- Subject in an exclusion period from another study
- Subjects under tutelage or subjects deprived of liberty
- Patients to be unable to understand the purpose of study
Trial locations and contacts
1 site in 1 country.
France1 site
Emergency Department of University Hospital Grenoble
Grenoble, Auvergne Rhonalpes, 38043
About this study
Official title: Multimodal Oral Analgesia for Trauma in the Emergency Department: a Prospective Observational Study of a Nurse-directed Protocol
The prevalence of pain in the emergency department is estimated between 60% and 78%. However, many studies reported oligo analgesia in about half of patient admitted to the emergency department. The delay before effective analgesia is one of the main causes of oligoanalgesia. The use of nurse-directed protocol allows the administration of analgesic upon admission to the emergency department. Nevertheless the need of intravenous access may delay analgesia. The use of oral form analgesics even with immediate release does not allow effective analgesia before 20 min. Pain management protocol in the emergency reception desk of CHU Grenoble Alpes (CHUGA) includes paracetamol that can be combined with oxycodone tablets depending on the pain intensity. For any mono traumatized it is possible to associate self-administer methoxyflurane inhaler. The pain management protocol is already used in the emergency reception desk of CHU Grenoble Alpes.The different analgesics( paracetamol,oral oxycodone, methoxyflurane) are already administered as part of routine care.The use of these different analgesics means would allow a rapid and adapted effectiveness to the pain intensity. However, there are no data on the efficacy and acceptability of such an early multimodal analgesia protocol in the emergency department.
Read the detailed description
200 Patients will be included from 8:00 am to 8:00 pm and will receive a multimodal analgesia under the nurse-directed pain management protocol (paracetamol +/- oral oxycodone +/- methoxyflurane) as part of routine medical care.
The pain will be evaluated (Numerical rating scale) prior to the administration and reassessed by a nurse every 5 minutes for 30 minutes and then at 45min and 1 hour after administration of the pain protocol. Satisfaction of patients and caregivers will also be assessed at the end of care.
- Conditions
- Pain
- Keywords
- Emergency, trauma pain, analgesia, Methoxyfurane
- Medical subject headings
- Pain, Emergencies, Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a score of less than or equal to 3 on a pain Numeric Rating scale (NRS) (0-10) 15 minutes after inclusion
NRS scale (0-10)
Measured: 15 minutes after inclusion
Secondary outcomes (3)
Secondary efficacy criteria
Delay of pain relief defined by a 2 point reduction in the NRS scale (0-10)
Measured: 15, 30 and 45 min (after inclusion)
Number of patient with 30% reduction in pain intensity
NRS scale (0-10)
Measured: 15,30 and 45 min (after inclusion)
Satisfaction of caregiver and patient
Patient and caregiver satisfaction evaluated by a visual analog scale (VAS), covering the whole range of analgesic management and in particular each component of multimodal analgesia. The VAS scale ranges are : (not at all satisfied I will not take again - quite satisfied i will take again) for the patient and (not at all satisfied i will not give again - quite satisfied i will give again) for the caregiver
Measured: 1h after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start12 Oct 2017
- Primary completion6 Jul 2018
- Study completion6 Jul 2018
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Mundipharma Pte Ltd.
- Responsible party
- Sponsor
- Investigators
- Maxime MAIGNAN, MD PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380247
- Sponsor's protocol ID
- 38RC17.157
- Other IDs
- RCB-2017-A01706-47
- Acronym
- START
- Status last verified
- Aug 2018
- First submitted
- 28 Nov 2017
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Viglino D, Termoz Masson N, Verdetti A, Champel F, Falcon C, Mouthon A, Mabiala Makele P, Collomb Muret R, Maindet Dominici C, Maignan M. Multimodal oral analgesia for non-severe trauma patients: evaluation of a triage-nurse directed protocol combining methoxyflurane, paracetamol and oxycodone. Intern Emerg Med. 2019 Oct;14(7):1139-1145. doi: 10.1007/s11739-019-02147-8. Epub 2019 Jul 9.
PubMed 31290084
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Oral Analgesia for Trauma in the Emergency Department: a Prospective Observational Study of a Nurse-directed Protocol
- ClinicalTrials.gov ID
- NCT03380247
- Acronym / sponsor ID
- START / 38RC17.157
- Conditions
- Pain
- Keywords
- Emergency, trauma pain, analgesia, Methoxyfurane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Mundipharma Pte Ltd.
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 21 Dec 2017 (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 prevalence of pain in the emergency department is estimated between 60% and 78%. However, many studies reported oligo analgesia in about half of patient admitted to the emergency department. The delay before effective analgesia is one of the main causes of oligoanalgesia. The use of nurse-directed protocol allows the administration of analgesic upon admission to the emergency department. Nevertheless the need of intravenous access may delay analgesia. The use of oral form analgesics even with immediate release does not allow effective analgesia before 20 min. Pain management protocol in the emergency reception desk of CHU Grenoble Alpes (CHUGA) includes paracetamol that can be combined with oxycodone tablets depending on the pain intensity. For any mono traumatized it is possible to associate self-administer methoxyflurane inhaler. The pain management protocol is already used in the emergency reception desk of CHU Grenoble Alpes.The different analgesics( paracetamol,oral oxycodone, methoxyflurane) are already administered as part of routine care.The use of these different analgesics means would allow a rapid and adapted effectiveness to the pain intensity. However, there are no data on the efficacy and acceptability of such an early multimodal analgesia protocol in the emergency department.
Detailed description
200 Patients will be included from 8:00 am to 8:00 pm and will receive a multimodal analgesia under the nurse-directed pain management protocol (paracetamol +/- oral oxycodone +/- methoxyflurane) as part of routine medical care.
The pain will be evaluated (Numerical rating scale) prior to the administration and reassessed by a nurse every 5 minutes for 30 minutes and then at 45min and 1 hour after administration of the pain protocol. Satisfaction of patients and caregivers will also be assessed at the end of care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted at the emergency for non-multiple trauma pain
Key inclusion criteria (4 listed)
- Adult patients : ≥ 18 year and older
- Trauma pain
- NRS≥ 4
- Non- opposition to participate in the study
Key exclusion criteria (16 listed)
- Trauma with at least one of the following severity criteria:
- Altered level of consciousness (Glasgow score < 15)
- Patients who took any analgesic within 4 hours prior to admission (except paracetamol)
- Use of nitrous oxide in the hour before admission
- Patient requiring an intravenous access at admission (e.g. : open fracture displaced)
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
Proportion of patients with a score of less than or equal to 3 on a pain Numeric Rating scale (NRS) (0-10) 15 minutes after inclusion
Time frame: 15 minutes after inclusion
NRS scale (0-10)
3 secondary outcomes
Secondary efficacy criteria
Time frame: 15, 30 and 45 min (after inclusion)
Number of patient with 30% reduction in pain intensity
Time frame: 15,30 and 45 min (after inclusion)
Satisfaction of caregiver and patient
Time frame: 1h after inclusion
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 3 Aug 2018.
- Derived from this study: PubMed 31290084Viglino D, Termoz Masson N, Verdetti A, Champel F, Falcon C, Mouthon A, Mabiala Makele P, Collomb Muret R, Maindet Dominici C, Maignan M. Multimodal oral analgesia for non-severe trauma patients: evaluation of a triage-nurse directed protocol combining methoxyflurane, paracetamol and oxycodone. Intern Emerg Med. 2019 Oct;14(7):1139-1145. doi: 10.1007/s11739-019-02147-8. Epub 2019 Jul 9.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Maxime MAIGNAN, MD PhD principal investigator
University Hospital, Grenoble
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 University Hospital, Grenoble 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 16 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 3 Aug 2018. 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?
Proportion of patients with a score of less than or equal to 3 on a pain Numeric Rating scale (NRS) (0-10) 15 minutes after inclusion (time frame: 15 minutes after inclusion). 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 NCT03380247, 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 3 Aug 2018.