PENTHROX™ in the Canadian Emergency Department (ED)

NCT03868436 | Completed Phase 4

• 1 other identifier: CAN-MEOF-MA-OO1
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 6

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.

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• 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

  20 mins from start of administration (STA) of PENTHROX™

Secondary Outcomes (5)

• Speed of action of analgesia

  At any point from STA of PENTHROX™ to 20 mins post inhalation

• Proportion of treatment-emergent adverse events (TEAEs)

  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)

  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)

  At the end of the observation period (up to 24hours)

• Use of rescue medication

  From STA of PENTHROX™ to the end of the observation period (up to 24hours)

Study Arms (1)

Methoxyflurane (MEOF)-active treatment

OTHER

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

Drug: Methoxyflurane 3mL

Interventions

Methoxyflurane 3mL DRUG

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™

Methoxyflurane (MEOF)-active treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue Pharma, Canada: lead

Study Sites (6)

Charles V Keating Emergency and Trauma Centre, QEII

Halifax, Nova Scotia, B3H3A7, Canada

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

Location

Markham Stouffville

Markham, Ontario, L3P 7P3, Canada

Location

St. Joseph's Healthcare

Welland, Ontario, L3B4W6, Canada

Location

Centre Integre Universitaire De Sante Et De Service Sociaux (CIUSSS) Saguenay-Lac-Saint Jean

Chicoutimi, Quebec, G7H 7K9, Canada

Location

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre

Greenfield Park, Quebec, J4V 2H1, Canada

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Methoxyflurane

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers

Study Officials

• Sonja Dhani, PhD

  Purdue Pharma, Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 11, 2019
• Study Start: April 8, 2019
• Primary Completion: March 30, 2020
• Study Completion: September 8, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)