PENTHROX™ in the Canadian Emergency Department (ED)

• Status: Completed
• Trial end date: 2020-09-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Purdue Pharma, Canada
• Treatments: Methoxyflurane

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