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Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma (UMATH)

R

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Traumatic Injury
Pain

Treatments

Drug: Methoxyflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT03927729
DR190096
2019-A00259-48 (Other Identifier)

Details and patient eligibility

About

Study of traumatized patients treated in emergency departments of Tours, seeking to optimize the management of trauma pain in an inpatient setting, with the opportunity to integrate inhaled methoxyflurane (Penthrox®) into the arsenal analgesics useful in the analgesic protocol of the Reception and Orientation Nurse.

Full description

Intra-hospital, the prevalence of pain is major; this is variable depending on the studies, but permanently above 60%. A study conducted in 2015 in Tours Adult Emergencies showed a prevalence of pain of 66.5% with an average waiting time of 2h28 before receiving an analgesic.

The pain management protocol at the Tours emergency department includes paracetamol for a numerical evaluation scale (EN) < 3 and tramadol for an EN between 4 and 6. But these therapies have a delay of action too long or are given too late. An improvement in the management of pain in emergency is therefore necessary.

Methoxyflurane (Penthrox®) is a volatile fluoridated analgesic; it offers several benefits: fast over a long period, well tolerated, effective and without interference with other drugs. Despite a misuse in the 70s, it has been used for more than 20 years in Australia and New Zealand. It was granted marketing authorization in 2016 and has been marketed in France since 2017.

It should be noted that this analgesic treatment is already adopted in several hospitals in the region and also in the SAMU 37.

A similar study was conducted in Grenoble but on a different population. The investigators plan to highlight the interest of Penthrox® in the management of monotraumatic pains in the Adult Emergencies of Tours with the intention of modifying the antalgic protocol accordingly to the reception of emergencies.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Conscious patient
  • Age ≥ 18 years
  • Acute pain of monotraumatic origin
  • Pain > 4 on a visual numerical scale

Exclusion criteria

  • State of shock with unstable hemodynamics (PA <90/60)
  • Suspected or proven trauma to the chest, abdomen or pelvis
  • Serious head trauma
  • Consciousness disorder with Glasgow score <15
  • Patient who has already received analgesics (with the exception of paracetamol)
  • Patient receiving an intravenous approach for analgesia
  • Renal or hepatic disorders known
  • Hypersensitivity to fluoridated anesthetics or history of malignant hyperthermia in the patient or family
  • Pregnant or nursing woman
  • Patient under judicial protection
  • Non communicating patient or with difficulties of understanding

Exclusion Criteria:

  • Intravenous injection for analgesia

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 1 patient group

Penthrox
Experimental group
Description:
Patients with moderate to severe post-traumatic acute pain will be included in the emergency room.
Treatment:
Drug: Methoxyflurane

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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