Department of Nursing, Changhai Hospital, Second Military Medical University, 168 Changhai Road, Shanghai 200433, China.
Trials. 2012 May 24;13:67. doi: 10.1186/1745-6215-13-67.
Procedural burn pain is the most intense acute pain and most likely type of burn injury pain to be undertreated due to the physician's fear of the adverse effect of analgesia and lack of anesthetist present. At our institution, in most of the cases, local burn detersion and debridement were performed at the ward level without any analgesics. This article describes a study designed to test the analgesia effect of a fixed nitrous oxide/oxygen mixture on burn dressing pain.
METHODS/DESIGN: The experiment was carried out in three centers. The patients were given a number from 1 to 240. A randomization list was produced by a statistician according to our preliminary study. Due to the severity of the pain suffered, ethically it was decided to help as many as possible, so patients given the letters A, B or C were treated using a canister with the appropriate letter containing preprepared nitrous oxide/oxygen mixture (NOOM). Those with D were given oxygen only, from an identical-looking canister labeled D. Neither patients, nor doctors, nor nurses, nor data collector knew what was in each canister, thus they were all blind. The nursing officer who implemented the intervention handed the doctors envelopes containing the patients' name and allocation of A, B, C or D. Thus, patients receiving NOOM or oxygen were in the ratio 3:1. Parameters, including pain severity, blood pressure, heart rate, digital oxygen saturation and the Chinese version of the burn specific pain anxiety scale (C-BSPAS), were taken before, during and after dressing for each group. A video and audio record was taken individually for later communication coding and outcome analysis. Rescue analgesic was recorded.
Based on the findings from our previous qualitative study that physician's reluctance to order narcotic analgesia is due to its adverse effect and from our pilot experiment, this study aims to test the hypothesis that a fixed nitrous oxide/oxygen mixture will promote better burn dressing pain alleviation and outcomes. Analyses will focus on the effects of the experimental intervention on pain severity during dressing (primary outcomes); physiological parameters, C-BSPAS and acceptance of both health care professionals and patients (secondary outcomes). If this model of analgesia for burn pain management implemented by nurses proves successful, it could potentially be implemented widely in hospital and prehospital settings and improve patients' satisfaction and quality of life.
(Clinical Trials Identifier: CHICTR-TRC11001690).
程序烧烫伤疼痛是最剧烈的急性疼痛，也是最有可能未得到充分治疗的烧烫伤疼痛类型，这是由于医生担心镇痛的不良反应以及没有麻醉师在场。在我们的机构中，大多数情况下，局部烧伤冲洗和清创都是在病房进行的，没有使用任何止痛药。本文描述了一项旨在测试固定氧化亚氮/氧气混合物对烧伤换药疼痛的镇痛效果的研究。
方法/设计：该实验在三个中心进行。患者被编号为 1 至 240。根据我们的初步研究，统计学家生成了一份随机列表。由于疼痛的严重程度，从伦理上讲，尽可能多地帮助患者是很重要的，因此，给予字母 A、B 或 C 的患者使用装有预先准备好的氧化亚氮/氧气混合物（NOOM）的罐子进行治疗。给予字母 D 的患者仅给予来自外观相同的标有 D 的罐子的氧气。患者、医生、护士或数据收集者都不知道每个罐子里装的是什么，因此他们都是盲的。实施干预的护士长将装有患者姓名和 A、B、C 或 D 分配的信封交给医生。因此，接受 NOOM 或氧气的患者比例为 3:1。在每组患者接受换药之前、期间和之后，记录疼痛严重程度、血压、心率、数字血氧饱和度和中文版烧伤特定疼痛焦虑量表（C-BSPAS）等参数。为以后的沟通编码和结果分析单独录制视频和音频记录。记录急救止痛药。
基于我们之前的定性研究发现，医生不愿意开麻醉性镇痛药是因为它的不良反应，以及我们的初步实验，本研究旨在测试以下假设：固定的氧化亚氮/氧气混合物将促进更好的烧伤换药疼痛缓解和结果。分析将集中在实验干预对换药过程中疼痛严重程度的影响（主要结果）；生理参数、C-BSPAS 以及医护人员和患者的接受程度（次要结果）。如果由护士实施的这种烧伤疼痛管理的镇痛模式证明是成功的，它可能会在医院和院前环境中得到广泛实施，并提高患者的满意度和生活质量。
（临床试验标识符：CHICTR-TRC11001690）。
