PENTHROX™ in the Canadian Emergency Department (ED)
- Registration Number
- NCT03868436
- Lead Sponsor
- Purdue Pharma, Canada
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Methoxyflurane (MEOF)-active treatment Methoxyflurane 3mL single arm study all subjects will be treated with Methoxyflurane 3 mL
- Primary Outcome Measures
Name Time Method Change in mean pain intensity: Numerical Rating Scale 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
- Secondary Outcome Measures
Name Time Method Proportion of treatment-emergent adverse events (TEAEs) 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.
Speed of action of analgesia 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.Use of rescue medication 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.
Global Medication Performance (GMP) before discharge from ED (Patient & Health Care Professional) 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=ExcellentFulfillment of pain relief expectations (Patient & Healthcare professional) 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.
Trial Locations
- Locations (6)
Royal Victoria Regional Health Centre
🇨🇦Barrie, Ontario, Canada
St. Joseph's Healthcare
🇨🇦Welland, Ontario, Canada
Markham Stouffville
🇨🇦Markham, Ontario, Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
🇨🇦Greenfield Park, Quebec, Canada
Charles V Keating Emergency and Trauma Centre, QEII
🇨🇦Halifax, Nova Scotia, Canada
Centre Integre Universitaire De Sante Et De Service Sociaux (CIUSSS) Saguenay-Lac-Saint Jean
🇨🇦Chicoutimi, Quebec, Canada