PENTHROX™ in the Canadian Emergency Department (ED)

Study Overview
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Brief Summary
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This Canadian, multi-centre, prospective, real world study is designed to evaluate the effectiveness of low dose methoxyflurane (MEOF) (PENTHROX™) for the treatment of moderate to severe pain associated with trauma in the Canadian ED.

Detailed Description
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The study will assess the change in pain intensity over 20 minutes from start of administration of PENTHROX™ and will generate Real World Evidence in support of existing clinical trial data including effectiveness, safety and additional parameters of low dose MEOF (PENTHROX™) in Canadian EDs.

Official Title
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A Phase IV Real World Study on the Use of Low Dose Methoxyflurane (PENTHROX™) for the Treatment of Moderate to Severe Trauma Pain in the Canadian Emergency Department

Conditions
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Pain, Acute

Intervention / Treatment
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* Drug: Methoxyflurane 3mL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Conscious adult patients: ≥ 18 years of age Moderate to severe pain associated with trauma (NRS0-10 ≥ 4) which is unlikely to require surgery/hospitalization, such as Musculoskeletal injuries and physical wounds Fractures Lacerations Burns Dislocations Contusions Injury due to foreign bodies Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent Patient is able to follow all study requirements and procedures and complete required questionnaires Exclusion Criteria: Multi-level trauma Women of child bearing potential who are pregnant or peri partum, including labour An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol Clinically significant renal impairment A history of liver dysfunction after previous MEOF use or other halogenated anesthetics Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives Exacerbation of an underlying condition (i.e., chronic pain) Clinically evident or potential hemodynamic instability as per the opinion of the investigator Clinically evident respiratory impairment as per the opinion of the investigator Prior treatment with PENTHROX within 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Methoxyflurane (MEOF)-active treatment<br>single arm study all subjects will be treated with Methoxyflurane 3 mL | Drug: Methoxyflurane 3mL<br>* As soon as possible following enrollment and initial procedures, the patient will be supplied with a PENTHROX™ kit which includes one inhaler containing 3 mL of MEOF for pain management. A member of the research team will train the patient to self-administer MEOF. PENTHROX™ is an approved (trademarked) product in Canada and is commercially available in a combination blister pack with one 3 mL sealed bottle and one PENTHROX™ inhaler with the Activated Carbon (AC) chamber.<br>* Other names: PENTHROX™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean pain intensity: Numerical Rating Scale | The level of pain intensity will be collected by means of the Numerical Rating Scale (NRS). The NRS is considered a reliable and valid scale for assessing pain intensity and is preferred by patients for its simplicity. In this 11-point scale, the end points are the extremes of no pain and pain as bad as it could be, or worst pain (i.e. a score of 0 = no pain and a score of 10 = worst pain possible). Assessed by the patient 20 mins post PENTHROX™ inhalation | 20 mins from start of administration (STA) of PENTHROX™ | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of action of analgesia | Speed of action of analgesia is defined as the time at which the patient experiences meaningful pain relief following inhalation of PENTHROX™. The healthcare professional will instruct the patient to note the time at which they experience meaningful pain relief. The time point will be recorded in the case report form. | At any point from STA of PENTHROX™ to 20 mins post inhalation | 
| Proportion of treatment-emergent adverse events (TEAEs) | Assessment of patient reported adverse events throughout the observation period. | At any point From STA of PENTHROX™ until the end of the observation period (24 hours) | 
| Global Medication Performance (GMP) before discharge from ED (Patient & Health Care Professional) | Global medication performance (GMP) is an assessment of the health care professional's and patient's impression of how well a medication works. Global Medication Performance (GMP)-is a patient and health care provider reported outcome with the objective of assessing the health care professional's and patient's impression of how well a medication works. GMP is measured by asking the patient and health care professional a single question: rate the pain relief provided by PENTHROX™ utilizing a 5-point Likert scale where 1=Poor- 5=Excellent | at 20 minutes From STA of PENTHROX™ and at the end of the observation period (up to 24hours) | 
| Fulfillment of pain relief expectations (Patient & Healthcare professional) | Fulfillment of pain relief expectations- is a patient and health care professional reported outcome with the objective of assessing the health care professional's and patient's impression of how well a medication fulfilled their expectations. Fulfillment of pain relief expectations is measured by asking the patient and health care professional a single question: To what extent has your expectations regarding pain control been met and utilizing a 5-point Likert scale where 1=Poor- 5=Excellent. | At the end of the observation period (up to 24hours) | 
| Use of rescue medication | The time of first use of rescue medication after STA of PENTHROX™ up to and including 60 minutes will be documented. | From STA of PENTHROX™ to the end of the observation period (up to 24hours) |