A Phase 4 interventional study of Methoxyflurane 3mL in Pain, Acute, sponsored by Purdue Pharma, Canada. Completed at 6 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Purdue Pharma, Canada · Phase 4, Interventional, and Treatment
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.
1,694 studies on the registry are indexed under Emergencies; 332 are open to participants now.
This study's enrollment of 99 is below the median of 145 across 932 interventional studies indexed under Emergencies.
Browse Emergencies studies →Purdue Pharma, Canada is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Moderate to severe pain associated with trauma (NRS0-10 ≥ 4) which is unlikely to require surgery/hospitalization, such as
Exclusion Criteria:
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.
Also known as: PENTHROX™
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
Time frame: 20 mins from start of administration (STA) of PENTHROX™
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From STA of PENTHROX™ to the end of the observation period (up to 24hours)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Purdue Pharma, Canada