CompletedPhase 4

PENTHROX™ in the Canadian Emergency Department (ED)

Canada99 participantsStarted 2019-04-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Conscious adult patients: ≥ 18 years of age
✓. Moderate to severe pain associated with trauma (NRS0-10 ≥ 4) which is unlikely to require surgery/hospitalization, such as
✓. Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent
✓. Patient is able to follow all study requirements and procedures and complete required questionnaires

Exclusion criteria

✕. Multi-level trauma
✕. Women of child bearing potential who are pregnant or peri partum, including labour
✕. An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol
✕. Clinically significant renal impairment
✕. A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
✕. Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
✕. Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
✕. Exacerbation of an underlying condition (i.e., chronic pain)

What they're measuring

Change in mean pain intensity: Numerical Rating Scale

Timeframe: 20 mins from start of administration (STA) of PENTHROX™

Trial details

NCT IDNCT03868436

SponsorPurdue Pharma, Canada

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03-30

View on ClinicalTrials.gov More Pain, Acute trials