Clinical trial NCT03380247: Multimodal Oral Analgesia for Trauma in the Emergency Department
Official title: Multimodal Oral Analgesia for Trauma in the Emergency Department: a Prospective Observational Study of a Nurse-directed Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Emergency, trauma pain, analgesia, Methoxyfurane
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Mundipharma Pte Ltd.
First posted: 2017-12-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient admitted at the emergency for non-multiple trauma pain

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
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
timeFrame: 15 minutes after inclusion
Secondary outcomes:
measure: Secondary efficacy criteria
timeFrame: 15, 30 and 45 min (after inclusion)
measure: Number of patient with 30% reduction in pain intensity
timeFrame: 15,30 and 45 min (after inclusion)
measure: Satisfaction of caregiver and patient
timeFrame: 1h after inclusion
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Emergency Department of University Hospital Grenoble
state: Auvergne Rhonalpes
Study officials:
affiliation: University Hospital, Grenoble
name: Maxime MAIGNAN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.