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

Plunkett Consulting Group0 个研究点目标入组 500 人开始时间: 2018年11月14日最近更新: 2019年7月15日

适应症

试验速览

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•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.

•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

发起方

Plunkett Consulting Group