PENTHROX™ in the Canadian Emergency Department (ED) (ADVANCE-ED)
|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: NCT03868436|
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : September 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pain, Acute||Drug: Methoxyflurane 3mL||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||no masking|
|Official Title:||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|
|Actual Study Start Date :||April 8, 2019|
|Actual Primary Completion Date :||March 30, 2020|
|Actual Study Completion Date :||September 8, 2020|
Methoxyflurane (MEOF)-active treatment
single arm study all subjects will be treated with Methoxyflurane 3 mL
Drug: Methoxyflurane 3mL
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.
Other Name: PENTHROX™
- Change in mean pain intensity: Numerical Rating Scale [ Time Frame: 20 mins from start of administration (STA) of PENTHROX™ ]
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
- Speed of action of analgesia [ Time Frame: At any point from STA of PENTHROX™ to 20 mins post inhalation ]
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.
- Proportion of treatment-emergent adverse events (TEAEs) [ Time Frame: At any point From STA of PENTHROX™ until the end of the observation period (24 hours) ]Assessment of patient reported adverse events throughout the observation period.
- Global Medication Performance (GMP) before discharge from ED (Patient & Health Care Professional) [ Time Frame: at 20 minutes From STA of PENTHROX™ and at the end of the observation period (up to 24hours) ]
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
- Fulfillment of pain relief expectations (Patient & Healthcare professional) [ Time Frame: At the end of the observation period (up to 24hours) ]
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.
- Use of rescue medication [ Time Frame: From STA of PENTHROX™ to the end of the observation period (up to 24hours) ]The time of first use of rescue medication after STA of PENTHROX™ up to and including 60 minutes will be documented.
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): NCT03868436
|Canada, Nova Scotia|
|Charles V Keating Emergency and Trauma Centre, QEII|
|Halifax, Nova Scotia, Canada, B3H3A7|
|Royal Victoria Regional Health Centre|
|Barrie, Ontario, Canada, L4M 6M2|
|Markham, Ontario, Canada, L3P 7P3|
|St. Joseph's Healthcare|
|Welland, Ontario, Canada, L3B4W6|
|Centre Integre Universitaire De Sante Et De Service Sociaux (CIUSSS) Saguenay-Lac-Saint Jean|
|Chicoutimi, Quebec, Canada, G7H 7K9|
|Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre|
|Greenfield Park, Quebec, Canada, J4V 2H1|
|Study Director:||Sonja Dhani, PhD||Purdue Pharma, Canada|