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临床试验/ACTRN12619001376134
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

Monash University0 个研究点目标入组 40 人开始时间: 2019年10月9日最近更新:

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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