Haverkamp Frederike J C, Naidoo Ravi, Muhrbeck Måns, Pompermaier Laura, Wladis Andreas, van Laarhoven Cornelis J H M, Tan Edward C T H
Department of Surgery, Radboudumc, Nijmegen, The Netherlands
General Surgery and Burns Unit, Ngwelezana Tertiary Hospital, Empangeni, South Africa.
BMJ Open. 2025 Jul 28;15(7):e093761. doi: 10.1136/bmjopen-2024-093761.
Procedure-related pain should be minimised to prevent psychological trauma and the potential negative consequences on body physiology. Dressing changes in paediatric patients with burn injuries are frequently performed with analgesics alone where sedation is not indicated, especially in minor and superficial burns. It is hypothesised that distraction methods can be used in addition to pain alleviating medication to reduce the experience of pain in these patients.
With this research project, we aim to assess the effectiveness of a simple, inexpensive, non-electronic distraction method, a kaleidoscope, to reduce acute pain experienced in paediatric patients undergoing dressing changes in the outpatient clinic.
A randomised controlled trial will be performed at the Ngwelezana Tertiary Hospital, Empangeni, South Africa. Paediatric patients between the ages of 5 years and 12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomised into two groups with a 1:1 allocation ratio. Fixed randomisation will be performed by a computer random number generator. The control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as an additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when indicated according to hospital protocol. The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. Additionally, subanalyses will be performed to evaluate potentially modifying factors on the treatment effect. This will also be evaluated with a linear regression analysis and correlated with caregiver and healthcare worker observational pain scores. Participants and assessors are not blinded to group assignment due to the nature of the intervention. To achieve a power of 80% and a level of significance of 5% for detecting at least a 1-point difference in change in pain scores between the intervention and control group, a sample size of 50 patients in each group is required.
This study evaluates a non-invasive adjunct to reduce pain in children who undergo a painful procedure. Ethical approval has been granted from the University of Kwazulu-Natal's biomedical research and ethics committee and the ethics and research committee of Ngwelezana Tertiary Hospital prior to recruitment (ref no. BREC/00005194/2023). Written informed consent will be acquired from all study participants' caregivers. Study findings will be presented orally to staff at the paediatric burn unit of Ngwelezana Tertiary Hospital (study location). The research methodology and results will be presented at scientific conferences and will be submitted for publication in a peer-reviewed journal.
NCT06591195.
与操作相关的疼痛应降至最低，以防止心理创伤以及对身体生理产生潜在负面影响。对于烧伤的儿科患者，在不需要镇静的情况下，换药时通常仅使用镇痛药，尤其是对于轻度和浅表烧伤。据推测，除了缓解疼痛的药物外，还可使用分散注意力的方法来减轻这些患者的疼痛体验。
通过本研究项目，我们旨在评估一种简单、廉价的非电子分散注意力方法——万花筒，以减轻门诊换药的儿科患者的急性疼痛。
将在南非恩潘盖尼的恩格韦莱扎纳三级医院进行一项随机对照试验。年龄在5岁至12岁之间、轻度和浅表部分厚度烧伤且需要在门诊换药且无需镇静的儿科患者，将按1:1的分配比例随机分为两组。固定随机分组将由计算机随机数生成器执行。对照组将接受标准护理操作，即不采用任何分散注意力方法的换药，干预组将使用万花筒作为额外方法进行分散注意力，以减轻潜在疼痛。两组患者将根据医院方案在必要时服用扑热息痛或非甾体抗炎药。主要结局将是从操作前到换药期间疼痛评分的变化，并将采用线性回归分析进行分析。此外，将进行亚组分析以评估对治疗效果的潜在修正因素。这也将通过线性回归分析进行评估，并与护理人员和医护人员观察到的疼痛评分相关联。由于干预的性质，参与者和评估者对分组情况不设盲。为了达到80%的检验效能和5%的显著性水平，以检测干预组和对照组之间疼痛评分变化至少有1分的差异，每组需要50名患者的样本量。
本研究评估一种用于减轻接受痛苦操作儿童疼痛的非侵入性辅助方法。在招募患者之前，已获得夸祖鲁 - 纳塔尔大学的生物医学研究与伦理委员会以及恩格韦莱扎纳三级医院的伦理与研究委员会的伦理批准（参考编号：BREC/00005194/2023）。将从所有研究参与者的护理人员处获得书面知情同意书。研究结果将在恩格韦莱扎纳三级医院儿科烧伤病房（研究地点）向工作人员进行口头汇报。研究方法和结果将在科学会议上展示，并将提交至同行评审期刊发表。
NCT06591195。
