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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927729
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

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.

Condition or disease Intervention/treatment Phase
Pain Traumatic Injury Drug: Methoxyflurane Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Penthrox
Patients with moderate to severe post-traumatic acute pain will be included in the emergency room.
Drug: Methoxyflurane
Pain will be treated with inhaled methoxyflurane (Penthrox®).
Other Name: Penthrox®)




Primary Outcome Measures :
  1. Change of traumatic acute pain level between baseline and 15 minutes [ Time Frame: baseline and 15 minutes ]
    Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10)


Secondary Outcome Measures :
  1. Change of traumatic acute pain level between baseline and 30 minutes [ Time Frame: baseline and 30 minutes ]
    Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).

  2. Change of traumatic acute pain level between baseline and 45 minutes [ Time Frame: baseline and 45 minutes ]
    Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).

  3. Change of traumatic acute pain level between baseline and 60 minutes [ Time Frame: baseline and 60 minutes ]
    Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).

  4. Pain extinction duration [ Time Frame: baseline and 15, 30, 45, 60 minutes ]
    Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10)

  5. Penthrox tolerance [ Time Frame: 60 minutes ]
    Collection of side effects

  6. Medical team level of satisfaction [ Time Frame: 60 minutes ]
    5 grades satisfaction scale filled by the medical team 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied)

  7. Patient level of satisfaction [ Time Frame: 60 minutes ]
    5 grades satisfaction scale filled by the patient 30 minutes after the treatment (Very satisfied, Satisfied, Neutral, Dissatisfied, Very dissatisfied)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927729


Contacts
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Contact: Julien CONRAD, MD 02 47 47 90 22 ext +33 conrad@univ-tours.fr
Contact: céline BESNARD celinebesnard93@gmail.com

Locations
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France
Emergency Medical Service, University Hospital, Tours Recruiting
Tours, France, 37044
Principal Investigator: Julien CONRAD, MD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Principal Investigator: Julien CONRAS, MD University Hospital, Tours
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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03927729    
Other Study ID Numbers: DR190096
2019-A00259-48 ( Other Identifier: IdRCB )
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Tours:
Methoxyflurane
Penthrox
non opioid analgesia
traumatic pain
pain
antalgic protocol
emergency department
Additional relevant MeSH terms:
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Wounds and Injuries
Methoxyflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs