ACTRN12610000588099已完成4 期
A double blind randomised controlled trial assessing the analgesic equivalency of oxycodone, paracetamol and ibuprofen with codeine, paracetamol and ibuprofen or paracetamol and ibuprofen alone in moderate pain from musculoskeletal limb injuries presenting to the emergency department.
Southern Health Emergency Research Group0 个研究点目标入组 216 人开始时间: 2010年7月21日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years(—)
- 性别
- All
入选标准
- •1) Adult patients greater than or equal to18 years old and less than or equal to 75 years old AND
- •2) Limb injury within the preceding 48 hours AND
- •3) Initial verbal pain score elicited by the Triage Nurse of greater than 3/10 to less than or equal to 7/10 (ie 4 to 7/10)
排除标准
- •Need for any time critical interventions (e.g. reduction of dislocations or compound fractures) .
- •Digital injuries (pain from these should ideally be treated with digital block).
- •Pregnant and breastfeeding women (paracetamol and codeine are Category A drugs but Ibuprofen and oxycodone are Category C; with regard to lactation, paracetamol and ibuprofen are considered safe, but codeine and oxycodone are not recommended).
- •Asthma that may be Non-Steroidal Anti-inflammatory Drug (NSAID) sensitive.
- •Active peptic ulcer disease.
- •Known renal impairment.
- •Ethanol or recreational drug abuse or acute intoxication.
- •Use of any analgesic or sedating agent in the preceding 4 hours .
- •Regular use of analgesic agents for chronic pain.
- •Inability to take oral analgesics.
- •Known allergy or intolerance to paracetamol, to any opiate, or to any NSAID including Aspirin.
- •Patients not willing to comply with the recommendation not to drive, consume alcohol or operate machinery for at least 8 hours after being given the study drug combination.
- •Patients unable to understand the study explanation or unwilling to participate for whatever reason.
研究者
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