ClinicalTrials.gg
CompletedNCT03380247STARTUpdated Aug 3, 2018

Multimodal Oral Analgesia for Trauma in the Emergency Department

An observational study in Pain, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-03.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Pain by University Hospital, Grenoble — 3 open to participants now, 3 under way, none of them phase 3. Pain · University Hospital, Grenoble.

Started
2017
the only one that year
Observational
4 of 18
none open now
Registered
11th of 18
by date

Among the 18 studies in Pain by University Hospital, Grenoble, this one is the only one that started in 2017, is one of 4 observational ones, and was the 11th registered.

By phase

18 studies; the count open now beside each. This study's row is marked.

No phase12 · 3 open
Observationalthis study4 · 0 open
Other kind1 · 0 open
Phase 31 · 0 open

By the year they started

First in 2003; this study’s year is marked. 1 started in 2017.

Size and results

Median enrollment 70 across the 13 interventional studies, 50 across the 5 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 18 studies in Pain by University Hospital, Grenoble, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Pain

Keywords

  • Emergency, trauma pain, analgesia, Methoxyfurane
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient admitted at the emergency for non-multiple trauma pain

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No
06

What researchers measure

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)

    Time frame: 15 minutes after inclusion

Secondary outcomes

  1. Secondary efficacy criteria

    Delay of pain relief defined by a 2 point reduction in the NRS scale (0-10)

    Time frame: 15, 30 and 45 min (after inclusion)

  2. Number of patient with 30% reduction in pain intensity

    NRS scale (0-10)

    Time frame: 15,30 and 45 min (after inclusion)

  3. 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

    Time frame: 1h after inclusion

07

Study locations

1 site
  • Emergency Department of University Hospital Grenoble
    Grenoble, Auvergne Rhonalpes 38043, France
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03380247
Responsible party
Sponsor
First posted
Dec 21, 2017
Start date
Oct 12, 2017
Primary completion
Jul 6, 2018
Completion
Jul 6, 2018
Last update
Aug 3, 2018

Study contacts

Maxime MAIGNAN, MD PhD
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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