PENTHROX™ in the Canadian Emergency Department (ED)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-08

Study Completion Date

2020-09-08

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pain, Acute

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

no masking

Study Groups

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Methoxyflurane (MEOF)-active treatment

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

Group Type OTHER

Methoxyflurane 3mL

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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PENTHROX™

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No