Multimodal Oral Analgesia for Trauma in the Emergency Department

NCT03380247 | Completed

• 2 other identifiers: 38RC17.157RCB-2017-A01706-47
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pain

Keywords

Emergency, trauma pain, analgesia, Methoxyfurane

Outcome Measures

Primary Outcomes (1)

• 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)

  15 minutes after inclusion

Secondary Outcomes (3)

• Secondary efficacy criteria

  15, 30 and 45 min (after inclusion)

• Number of patient with 30% reduction in pain intensity

  15,30 and 45 min (after inclusion)

• Satisfaction of caregiver and patient

  1h after inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient admitted at the emergency for non-multiple trauma pain

You may qualify if:

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

You may not qualify if:

• 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
• Subjects under tutelage or subjects deprived of liberty
• Patients to be unable to understand the purpose of study

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Mundipharma Pte Ltd.: collaborator

Study Sites (1)

Emergency Department of University Hospital Grenoble

Grenoble, Auvergne Rhonalpes, 38043, France

Location

Related Publications (1)

• 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.

  PMID: 31290084 DERIVED

MeSH Terms

Conditions

Pain; Emergencies; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Maxime MAIGNAN, MD PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 21, 2017
• Study Start: October 12, 2017
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)