A multi-centre Retrospective, Comparative, Observational Study in Australia and New Zealand to Evaluate the Safety of repeated administration of PENTHROX® (methoxyflurane) for the treatment of Acute Pain associated with Burns and Wound Care Management

Not Applicable

Withdrawn

• Conditions: Acute pain; Injuries and Accidents - Burns; Injuries and Accidents - Other injuries and accidents; Drug safety; Anaesthesiology - Pain management

• Registration Number: ACTRN12618001849280
• Lead Sponsor: Plunkett Consulting Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-14
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

•Males and females, aged greater than or equal to 18 years.
•Patients who are hospital inpatients or managed through outpatient services for the treatment and management of burns or wound injury and require analgesia for the treatment of acute pain
•Patients whose burn’s coverage is less than 18% of body surface area as determined using the ‘Wallace Rules of Nines’ method (or equivalent)
•For methoxyflurane group - A minimum of 4 methoxyflurane doses for the treatment of acute pain associated with the management of burns or wound injury (including a minimum of two doses in the first 7 days and the other doses from Day 8 onwards) until methoxyflurane treatment cessation up to 28 days or to time of discharge
•For comparator group - A minimum of 4 doses of analgesic (e.g. nitrous oxide or short acting opioids) for the treatment of acute pain associated with the management of burns or wound injury (including a minimum of two doses in the first 7 days and the other doses from Day 8 onwards) until analgesic treatment cessation up to 28 days or until time of discharge.

Exclusion Criteria

Less than the minimum of 4 methoxyflurane or other short acting analgesic doses for the treatment of acute pain associated with the management of burns or wound injury (including a minimum of two doses in the first 7 days and the other doses from Day 8 onwards

Study & Design

• Study Type: Observational
• Study Design: Not specified