Multimodal Oral Analgesia for Trauma in the Emergency Department
NCT ID: NCT03380247
Last Updated: 2018-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2017-10-12
2018-07-06
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Trauma pain
* NRS≥ 4
* Non- opposition to participate in the study
Exclusion 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
* 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
18 Years
ALL
No
Sponsors
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Mundipharma Pte Ltd.
INDUSTRY
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Maxime MAIGNAN, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Emergency Department of University Hospital Grenoble
Grenoble, Auvergne Rhonalpes, France
Countries
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References
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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.
Other Identifiers
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RCB-2017-A01706-47
Identifier Type: OTHER
Identifier Source: secondary_id
38RC17.157
Identifier Type: -
Identifier Source: org_study_id
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