ACTRN12619001376134尚未招募2 期
Feasibility of prescribing non-steroidal anti-inflammatory drugs following surgical repair of long bone fracture healing: A placebo-controlled pilot RCT
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
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 65 Years(—)
- 性别
- All
入选标准
- •Participants will be eligible if they meet the following inclusion criteria:
- •- at least one tibial or femoral shaft fracture managed with either intramedullary nailing or plating
- •- an acute hospital length of stay>24 hours at The Alfred Hospital
- •- aged 18-65 years.
排除标准
- •Participants will be excluded if they present with:
- •- a pathological fracture related to metastatic disease, severe traumatic brain injury and/or spinal cord injury (recovery trajectory varies significantly from the majority of participants)
- •- less than conversational-level English (inability to engage in interviewing)
- •- multiple major fractures (bilateral tibia and/or femur; unilateral tibia and femur)
- •- a Glomerular Filtration Rate (GFR) below 60 mL/ min/1.73m2 or any contraindications to NSAID use (for example: known hypersensitivity including asthma/urticarial/allergic type reactions, allergy to sulphonamides, unstable ischaemic heart disease or thrombus or myocardial infarction or stroke within 3 months, active peptic ulceration or gastrointestinal bleeding, congestive heart failure NYHA II-IV, severe hepatic impairment – (Child-Pugh score greater or equal to 10).
- •- opioid and benzodiazepine addiction or opioid tolerance, and other regular illicit drug use or problematic alcohol use
研究者
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