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Use of Penthrox in Extra-hospital Traumatology (UPETEH)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537001
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:

In pre-hospital settings, the administration of analgesics is often delayed because of difficult patient access (incarceration), difficulty finding a venous pathway or patient refusal.

An optimization of the management of pain in urgency is therefore still necessary.

A side from nitrousoxide of which usage remains restrictive, methoxyflurane (Penthrox®) is the only volatile analgesic currently available for pre-hospital use.

The purpose of this study is to answer the question: Does the use of the inhaled route with Penthrox add value to the treatment of acute traumatic pain in the pre-hospital stage?


Condition or disease Intervention/treatment
Pain, Acute Trauma Injury Pain Management Other: Penthrox

Detailed Description:

In pre-hospital settings, the administration of analgesics is often delayed because of difficult patient access (incarceration), difficulty finding a venous pathway or patient refusal.

An optimization of the management of pain in urgency is therefore still necessary.

A side from nitrousoxide of which usage remains restrictive, methoxyflurane (Penthrox®) is the only volatile analgesic currently available for pre-hospital use.

Methoxyflurane (Penthrox®) is a single-use inhalation non-opioid analgesic for the management of moderate to severe traumatic pain. This treatment has been used in New Zealand and Canada for over 20 years for the management of acute pain in adults and children. It was granted marketing authorization in Europe in 2016 and has been marketed in France since 2017.

The purpose of this study is:

  • To study the efficacy and safety of Penthrox, administrated at the beginning of the management of the traumatized adult patient.
  • Assess the comfort of patients and caregivers
  • To answer the question: Does the use of the inhaled route with Penthrox add value to the treatment of acute traumatic pain in the pre-hospital stage?

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Inhaled Methoxyflurane (Penthrox®) as an Analgesic in Extra-hospital Traumatology at EMS37
Actual Study Start Date : August 29, 2017
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Penthrox
Administration of Penthrox at the beginning of the management of the traumatized adult patient
Other: Penthrox
Self-administration of penthrox by the patient under the supervision of a physician trained in its administration, in strict compliance with its MA.




Primary Outcome Measures :
  1. Change of traumatic acute pain level between baseline and 5 minutes [ Time Frame: Baseline, 5 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 10 minutes [ Time Frame: Baseline, 10 minutes ]
    Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).

  2. Pain extinction duration [ Time Frame: Baseline, 10 & 15 minutes ]
    Duration before pain extinction, evaluated using a visual numerical scale (VNS: between 0 and 10) at 0, 10 & 15 minutes.

  3. Penthrox tolerance [ Time Frame: Through study completion, an average of 30 minutes ]
    Collection of side effects

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

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

  6. Change of traumatic acute pain level between 0 and15 minutes [ Time Frame: Baseline, 15 minutes ]
    Efficiency will be measured by its effect on pain according to a visual numerical scale (VNS: between 0 and 10).



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
Sampling Method:   Non-Probability Sample
Study Population
Patients treated by the ER at Tours hospital which correspond to the inclusion, non-inclusion & exclusion criterias.
Criteria

Inclusion Criteria:

  • Conscious Patient
  • Age ≥ 18 years
  • Acute pain only of traumatic origin
  • Pain > 4 on a visual numerical scale (VNS)
  • Stable hemodynamic conditions (PA> 90/60)

Non Inclusion Criteria:

  • Pregnant or nursing woman
  • Patient who has already received analgesics
  • Patient benefiting from an intravenous approach for analgesia
  • Known renal or hepatic disease
  • Hypersensitivity to fluorinated anesthetics or history of malignant hyperthermia of the patient or family.
  • Respiratory distress
  • Patient who objected to the processing of his data

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): NCT03537001


Locations
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France
Emergency Medical Service, University Hospital, Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Principal Investigator: Sanaa El Azhari, MD sanaa.elazari@gmail.com
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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03537001    
Other Study ID Numbers: RIPH3-RNI17/UPETEH
2017-A01077-46 ( Other Identifier: IdRCB )
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
anesthetic
analgesia
acute
traumatic
pain
prehospital setting
visual numeric scale
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations