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Completed

NCT Number: NCT03868436

PENTHROX™ in the Canadian Emergency Department (ED)

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charles V Keating Emergency and Trauma Centre, QEII, Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PENTHROX™

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Purdue Pharma, Canada

Industry

Registry information

Official study 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

Acronym: ADVANCE-ED

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 11, 2019
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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