Pre‐mixed nitrous oxide/oxygen mixture treatment of pain induced by postoperative dressing change for perianal abscess: Study protocol for a randomized, controlled trial

Aim This study aims to evaluate the safety and analgesic efficacy of pre‐mixed nitrous oxide/oxygen mixture treatment of pain induced by dressing change for perianal abscess. Design This protocol is a randomized, double‐blind, placebo‐controlled trial. Methods This study will be implemented in the Hospital of Traditional Chinese Medicine. Subjects enrolled in this study are hospitalized patients who suffered from moderate to severe pain due to dressing change after incision and drainage. Two hundred patients will be selected and randomly assigned to either an intervention or a control group. The intervention group will get routine pain treatment plus pre‐mixed nitrous oxide/oxygen mixture treatment and the control group will be treated with routine pain management plus medical air treatment. All these patients, medical staff and investigators are blind to the nature of the gas in each cylinder, which is randomized. Data will be collected at baseline (T0), 5 min (T1) after the starting of intervention and 5 min post intervention (T2) for each group. The primary outcome is the level of pain relief at T1 and T2. The secondary outcomes cover physiological parameters, adverse events, satisfaction of patients and health professionals and the acceptance from patients. Discussion Results of this study will be discussed and the safety and effect of nitrous oxide/oxygen treatment of pain induced by dressing change will be proven. Impact When the finding of this study has an active effect on the treatment of pain caused by dressing change, it may provide more options for nursing staff to choose nurse‐led analgesia techniques and then improving the level and quality of pain care as well as patients’ overall satisfaction with the Anorectal Department in China. 摘要 目的 本研究旨在评估肛周脓肿术后换药引起疼痛时的预混合一氧化二氮/氧气混合物治疗的安全性和镇痛效果。 设计 该方案是一项随机、双盲、安慰剂对照试验。 方法 本研究将在中医医院实施。本研究的受试者是因切开引流后换药而引起中度至重度疼痛的住院患者。共计200名患者,这些患者将被随机分配到干预组或对照组。干预组接受常规疼痛治疗加上预混合一氧化二氮/氧气混合物治疗,而对照组主要接受常规疼痛治疗和医用气体治疗。所有患者、医务人员和调查人员都不清楚气瓶中气体的性质,并且,这些气瓶都是随机分配。应分别在基线(T0)、干预开始后5分钟(T1)和干预结束后5分钟(T2)收集数据。主要疼痛缓解结果见T1和T2。次要结果包括生理参数、不良事件、患者和卫生专业人员的满意度以及患者的接受程度等。 讨论 将讨论这项研究的结果,并对一氧化二氮/氧气治疗换药引起的疼痛的安全性和效果进行证明。 影响 如果本研究的调查结果显示,治疗过程中,换药引起的疼痛可带来积极影响,则可为护理人员选择镇痛技术,并且所选择的阵痛技术将由护士主导,从而提高我国肛肠科疼痛护理的水平和质量,提高患者的整体满意度,并可为患者提供更多选择。