Status:

COMPLETED

Multimodal Oral Analgesia for Trauma in the Emergency Department

Lead Sponsor:

University Hospital, Grenoble

Collaborating Sponsors:

Mundipharma Pte Ltd.

Conditions:

Pain

Eligibility:

All Genders

18+ years

Brief 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 d...

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 p...

Eligibility Criteria

Inclusion

  • Adult patients : ≥ 18 year and older
  • Trauma pain
  • NRS≥ 4
  • Non- opposition to participate in the study

Exclusion

  • 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
  • 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

Key Trial Info

Start Date :

October 12 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 6 2018

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT03380247

Start Date

October 12 2017

End Date

July 6 2018

Last Update

August 3 2018

Active Locations (1)

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1

Emergency Department of University Hospital Grenoble

Grenoble, Auvergne Rhonalpes, France, 38043