Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methoxyflurane (MEOF)-active treatment | Other | single arm study all subjects will be treated with Methoxyflurane 3 mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxyflurane 3mL | Drug | 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. |
| 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™ |
| 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 |
Not provided
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
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sonja Dhani, PhD | Purdue Pharma, Canada | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles V Keating Emergency and Trauma Centre, QEII | Halifax | Nova Scotia | B3H3A7 | Canada | ||
| Royal Victoria Regional Health Centre |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008733 | Methoxyflurane |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
Not provided
Not provided
Not provided
Not provided
Not provided
no masking
Not provided
|
|
| 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) |
| Barrie |
| Ontario |
| L4M 6M2 |
| Canada |
| Markham Stouffville | Markham | Ontario | L3P 7P3 | Canada |
| St. Joseph's Healthcare | Welland | Ontario | L3B4W6 | Canada |
| Centre Integre Universitaire De Sante Et De Service Sociaux (CIUSSS) Saguenay-Lac-Saint Jean | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre | Greenfield Park | Quebec | J4V 2H1 | Canada |