Centre for Children's Burns and Trauma Research, Centre for Children's Health Research, South Brisbane, Queensland, Australia
Pegg Leditschke Paediatric Burns Centre, The Queensland Children's Hospital, Herston, Queensland, Australia.
BMJ Open. 2021 Jan 5;11(1):e039981. doi: 10.1136/bmjopen-2020-039981.
OBJECTIVE: To compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid. DESIGN: Single-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial. PARTICIPANTS AND SETTING: Paediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children's Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017-September 2018. INTERVENTIONS: Patients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing. PRIMARY AND SECONDARY OUTCOMES: Observational pain scores from nursing staff assessed 5 min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred. RESULTS: Seventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: -0.1, 95% CI -0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95% CI -8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95% CI -1.7 to 2.2, p=0.78), heart rate (MD: -3, 95% CI -11 to 5, p=0.41), temperature (MD: 0.6, 95% CI -0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95% CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: -1, 95% CI -3 to 1, p=0.26) were identified between the two groups. CONCLUSIONS: A clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12617001274369).
目的：比较两种急性烧伤敷料——烧伤凝胶敷料和增塑聚氯乙烯薄膜在对接受适当急救的小儿烧伤患者进行治疗时，对减轻急性疼痛评分的效果。 设计：单中心、优效性、双臂、平行组、前瞻性随机对照试验。 参与者和设置：2017 年 9 月至 2018 年 9 月，澳大利亚布里斯班昆士兰儿童医院急诊科就诊的小儿（年龄≤16 岁）热烧伤患者符合入选条件，参与本试验。 干预措施：患者被随机分配接受烧伤凝胶敷料（干预组）或增塑聚氯乙烯薄膜（对照组）作为急性烧伤敷料。 主要和次要结局：护理人员在应用随机敷料后 5 分钟评估的观察性疼痛评分，使用面部腿部活动哭泣和安抚量表（Face Legs Activity Cry and Consolability Scale）进行测量，是主要结局。在随访更换敷料时，还收集了疼痛、应激和再上皮化的重复测量值，直到 95%的伤口再上皮化发生。 结果：共招募并随机分配了 72 名儿童（n=37 干预组；n=35 对照组）。护理人员（平均差值：-0.1，95%置信区间-0.7 至 0.5，p=0.72）或照顾者（MD：1，95%置信区间-8 至 11，p=0.78）观察到的疼痛评分在组间无显著差异。此外，儿童自我报告的疼痛（MD：0.3，95%置信区间-1.7 至 2.2，p=0.78）、心率（MD：-3，95%置信区间-11 至 5，p=0.41）、体温（MD：0.6，95%置信区间-0.13 至 0.24，p=0.53）、应激（几何均数比：1.53，95%置信区间 0.93 至 2.53，p=0.10）或再上皮化率（MD：-1，95%置信区间-3 至 1，p=0.26）在两组之间均无显著差异。 结论：在本研究中，并未发现烧伤凝胶敷料作为急救治疗小儿急性烧伤的辅助镇痛剂有明显的益处。 试验注册：澳大利亚新西兰临床试验注册中心（ACTRN12617001274369）。
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