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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 : Suspended (Recruitment is complete however study suspended due to COVID 19)
First Posted : March 11, 2019
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain, Acute Drug: Methoxyflurane 3mL Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Treatment
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
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
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™




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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


  4. 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.


  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Conscious adult patients: ≥ 18 years of age
  2. 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
  3. Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent
  4. Patient is able to follow all study requirements and procedures and complete required questionnaires

Exclusion Criteria:

  1. Multi-level trauma
  2. Women of child bearing potential who are pregnant or peri partum, including labour
  3. An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol
  4. Clinically significant renal impairment
  5. A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
  6. Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
  7. Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
  8. Exacerbation of an underlying condition (i.e., chronic pain)
  9. Clinically evident or potential hemodynamic instability as per the opinion of the investigator
  10. Clinically evident respiratory impairment as per the opinion of the investigator
  11. Prior treatment with PENTHROX within 3 months

Information from the National Library of Medicine

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


Locations
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Canada, Nova Scotia
Charles V Keating Emergency and Trauma Centre, QEII
Halifax, Nova Scotia, Canada, B3H3A7
Canada, Ontario
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
Markham Stouffville
Markham, Ontario, Canada, L3P 7P3
St. Joseph's Healthcare
Welland, Ontario, Canada, L3B4W6
Canada, Quebec
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
Sponsors and Collaborators
Purdue Pharma, Canada
Investigators
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Study Director: Sonja Dhani, PhD Purdue Pharma, Canada
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Responsible Party: Purdue Pharma, Canada
ClinicalTrials.gov Identifier: NCT03868436    
Other Study ID Numbers: CAN-MEOF-MA-OO1
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Methoxyflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs