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PENTHROX™ in the Canadian Emergency Department (ED) (ADVANCE-ED)

Primary Purpose

Pain, Acute

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Methoxyflurane 3mL
Sponsored by
Purdue Pharma, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charles V Keating Emergency and Trauma Centre, QEII
  • Royal Victoria Regional Health Centre
  • Markham Stouffville
  • St. Joseph's Healthcare
  • Centre Integre Universitaire De Sante Et De Service Sociaux (CIUSSS) Saguenay-Lac-Saint Jean
  • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Methoxyflurane (MEOF)-active treatment

Arm Description

single arm study all subjects will be treated with Methoxyflurane 3 mL

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Proportion of treatment-emergent adverse events (TEAEs)
Assessment of patient reported adverse events throughout the observation period.
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
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.
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.

Full Information

First Posted
February 21, 2019
Last Updated
September 14, 2021
Sponsor
Purdue Pharma, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03868436
Brief Title
PENTHROX™ in the Canadian Emergency Department (ED)
Acronym
ADVANCE-ED
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
September 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Purdue Pharma, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
no masking
Allocation
N/A
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methoxyflurane (MEOF)-active treatment
Arm Type
Other
Arm Description
single arm study all subjects will be treated with Methoxyflurane 3 mL
Intervention Type
Drug
Intervention Name(s)
Methoxyflurane 3mL
Other Intervention Name(s)
PENTHROX™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean pain intensity: Numerical Rating Scale
Description
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™
Secondary Outcome Measure Information:
Title
Speed of action of analgesia
Description
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
Title
Proportion of treatment-emergent adverse events (TEAEs)
Description
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)
Title
Global Medication Performance (GMP) before discharge from ED (Patient & Health Care Professional)
Description
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)
Title
Fulfillment of pain relief expectations (Patient & Healthcare professional)
Description
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)
Title
Use of rescue medication
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonja Dhani, PhD
Organizational Affiliation
Purdue Pharma, Canada
Official's Role
Study Director
Facility Information:
Facility Name
Charles V Keating Emergency and Trauma Centre, QEII
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H3A7
Country
Canada
Facility Name
Royal Victoria Regional Health Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Markham Stouffville
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 7P3
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Welland
State/Province
Ontario
ZIP/Postal Code
L3B4W6
Country
Canada
Facility Name
Centre Integre Universitaire De Sante Et De Service Sociaux (CIUSSS) Saguenay-Lac-Saint Jean
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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PENTHROX™ in the Canadian Emergency Department (ED)

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