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首页> 外文期刊>Trials >Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric thermal burn injuries: study protocol for a randomised controlled trial
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Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric thermal burn injuries: study protocol for a randomised controlled trial

机译:水凝胶敷料作为镇痛辅助治疗急性小儿热烧伤伤害的效果的有效性:随机对照试验的研究方案

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Burns are a painful and traumatic experience, particularly in children. Reduced pain and anxiety positively influences re-epithelialisation rates in paediatric burn patients, however current literature fails to fully explain the effects of pain and anxiety and their links with wound healing. This study will determine if Burnaid? hydrogel dressing is an effective treatment for reducing pain in the acute period of a burn injury. It is hypothesised that a reduction in pain will then improve re-epithelialisation time in comparison to plastic wrap, which is standard practice at our institution - a metropolitan tertiary paediatric hospital located in Brisbane, Australia. A randomised controlled trial will be conducted to assess the effectiveness of Burnaid? as an analgesic adjunct to cold running water first aid for the treatment of paediatric burns. Participants will include children aged between 0 and 16?years with an acute thermal burn injury (total burn surface area ?20%) presenting to the Department of Emergency within 24?h of the burn occurring. Participants will be randomised into one of two groups: (1) Burnaid? hydrogel (intervention arm) or (2) plastic wrap (control arm). Participants will also be stratified into one of two groups based on factors that influence pain intensity: (1) high pain risk or (2) low pain risk. High pain risk factors include foot burns, hot coal/ash/fire pit burns, burn area greater than 5%, and circumferential burns. The primary outcome is the intervention's effect on reducing acute pain. Secondary outcomes include days to re-epithelialisation, pulse rate, temperature, salivary cortisol and α-amylase, anxiety, and cost-effectiveness. Sample size calculations have shown that 36 participants will be recruited into each group. This study will provide comprehensive data on the analgesic properties of Burnaid? as an adjunct to first aid for the treatment of acute paediatric thermal burns. If the intervention is effective in reducing pain, Burnaid? will be integrated as standard practice within the hospital's Department of Emergency. This study replicates a real-world scenario in order to identify clinically significant analgesic and wound-healing effects. Australian New Zealand Clinical Trials Registry, ACTRN12617001274369 . Prospectively registered on 5 Sept 2017.
机译:烧伤是一种痛苦和创伤的经验,特别是在儿童中。减少疼痛和焦虑积极影响儿科烧伤患者的再上皮性率,但目前的文献未能充分解释疼痛和焦虑的影响及其与伤口愈合的联系。这项研究将确定是否有烧伤?水凝胶敷料是一种有效的治疗,用于减少燃烧伤害的急性时期疼痛。假设疼痛的降低将改善与塑料包装相比的重新上皮化时间,这是我们机构的标准做法 - 位于澳大利亚布里斯班的大都市高等教育医院。将进行随机对照试验以评估烧伤的有效性吗?作为镇痛辅助冷水水的急救治疗儿科烧伤。参与者将包括0到16岁的儿童,急性热烧伤(总烧伤表面区域<20%)在烧伤24℃内呈现给紧急情况。参与者将被随机分为两组之一:(1)伯德?水凝胶(干预臂)或(2)塑料包装(控制臂)。根据影响疼痛强度的因素,参与者也将分为两组之一:(1)高疼痛风险或(2)低疼痛风险。高疼痛的风险因素包括脚烧,热煤/灰/防火坑烧伤,烧伤面积大于5%,并圆周烧伤。主要结果是干预对降低急性疼痛的影响。二次结果包括重新上皮,脉搏率,温度,唾液皮质醇和α-淀粉酶,焦虑和成本效益的日子。样本大小计算表明,将招募36名参与者将招募到每组。本研究将提供关于烧伤症的镇痛性质的综合数据?作为急救治疗急性小儿热烧伤的辅助辅助。如果干预有效减少疼痛,烧伤?将作为医院紧急部门内的标准做法融为一体。本研究复制了真实世界的情景,以确定临床显着的镇痛和伤口愈合效果。澳大利亚新西兰临床试验登记处,ACTRN12617001274369已前瞻性注册于2017年9月5日。

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