NCT03868436

PENTHROX™ in the Canadian Emergency Department (ED)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Purdue Pharma, Canada · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pain, Acute

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-08
• Primary completion: 2020-03-30
• Completion: 2020-09-08
• First posted: 2019-03-11
• Last updated: 2021-09-16

Locations

6 sites across 1 country: Canada