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

NCT03927729 | Completed

• 2 other identifiers: DR1900962019-A00259-48
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Traumatic Injury

Keywords

Methoxyflurane; Penthrox; non opioid analgesia; traumatic pain; pain; antalgic protocol; emergency department

Outcome Measures

Primary Outcomes (1)

• Change of traumatic acute pain level between baseline and 15 minutes

  Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10)

  baseline and 15 minutes

Secondary Outcomes (7)

• Change of traumatic acute pain level between baseline and 30 minutes

  baseline and 30 minutes

• Change of traumatic acute pain level between baseline and 45 minutes

  baseline and 45 minutes

• Change of traumatic acute pain level between baseline and 60 minutes

  baseline and 60 minutes

• Pain extinction duration

  baseline and 15, 30, 45, 60 minutes

• Penthrox tolerance

  60 minutes

Study Arms (1)

Penthrox

EXPERIMENTAL

Patients with moderate to severe post-traumatic acute pain will be included in the emergency room.

Drug: Methoxyflurane

Interventions

Methoxyflurane DRUG

Pain will be treated with inhaled methoxyflurane (Penthrox®).

Also known as: Penthrox®)

Penthrox

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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
• Intravenous injection for analgesia

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Emergency Medical Service, University Hospital, Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Pain; Wounds and Injuries; Emergencies

Interventions

Methoxyflurane

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers

Study Officials

• Julien CONRAS, MD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: June 7, 2019
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

FR (1)