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

Purdue Pharma

Status and phase: Completed; Phase 4

Conditions: Pain, Acute

Treatments: Drug: Methoxyflurane 3mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03868436

CAN-MEOF-MA-OO1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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99 participants in 1 patient group

Methoxyflurane (MEOF)-active treatment

Other group

Description:

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

Treatment:

Drug: Methoxyflurane 3mL