PENTHROX™ in the Canadian Emergency Department (ED)
NCT03868436 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99
Last updated 2021-09-16
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
Interventions
- DRUG
-
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.
Sponsors & Collaborators
-
Purdue Pharma, Canada
lead INDUSTRY
Principal Investigators
-
Sonja Dhani, PhD · Purdue Pharma, Canada
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-08
- Primary Completion
- 2020-03-30
- Completion
- 2020-09-08
Countries
- Canada
Study Locations
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