摘要

研究背景：先天性小耳畸形（Congenital Microtia）是由于胚胎时期第一、二腮弓及第一腮沟发育异常引起的外、中耳畸形，其发病率仅次于唇颚裂，是最常见的头颅面部畸形之一。耳廓再造术是目前首选的治疗方法，手术适宜年龄为六到八周岁，通过取出自体肋软骨、雕刻成耳支架、耳支架埋入皮下的过程来解决患者外表形态异常的问题。胸部切口处急性疼痛是患儿术后最常见的主诉之一。疼痛不仅给患者带来的痛苦的感受，还会对整个机体的各个系统造成不同程度的影响，因此，采取有效措施缓解术后疼痛十分重要。目前研究多聚焦于改良镇痛药物及麻醉方式以减轻患者术后疼痛，但可能产生额外的成本和侵入性操作。还有些问题是仅凭药物措施无法解决的，例如患儿缺乏疼痛相关知识，因不当的行为（如用力哭喊、挺起胸部）致疼痛加剧，需要采取适当的护理措施进行干预。已有研究者尝试通过护理措施缓解患者术后疼痛，得到了较好的反馈。但存在研究样本量少、干预措施单一（如干预措施仅有体位护理）等问题。因此，有必要为先天性小耳畸形患儿构建科学有效、系统完整的自体肋软骨采取术术后疼痛护理干预方案。

研究目的：在循证的基础上，结合专家意见，制定《先天性小耳畸形患儿肋软骨采取术术后疼痛护理干预方案》；在临床中实施此方案，以初步检验其临床应用效果。

研究方法：

1.制定干预方案

采用文献分析法，系统检索耳畸形患儿疼痛干预相关的临床支持决策系统、临床实践指南、专家共识、系统评价和原始研究，采用临床指南研究与评价系统II（Appraisal of Guidelines for Research and Evaluation, AGREE II）和澳大利亚循证卫生保健研究中心（Joanna Briggs Institute, JBI）的文献质量评价标准和证据分级标准进行文献质量评价和证据等级划分，提取纳入文献中与患儿疼痛干预相关的信息，形成耳畸形患儿肋软骨采取术术后疼痛护理干预方案初稿；采用德尔菲法，征询12名来自耳畸形诊疗、护理、麻醉、护理教育领域专家对疼痛护理干预方案初稿的意见，最终形成耳畸形患儿肋软骨采取术术后疼痛护理干预方案。

2.评价干预方案的临床应用效果

本研究行类实验性研究，采用便利抽样法，对照组选取北京市某三级甲等整形专科医院外耳再造病房2024年7月～9月接受肋软骨采取术的患儿共47例；干预组选取2024年10月～12月在同一病房接受肋软骨采取术的患儿共47例。对照组患儿接受耳再造病房常规护理；干预组患儿在接受病房常规护理的同时，还接受《先天性小耳畸形患儿肋软骨采取术术后疼痛护理干预方案》的干预。记录患儿术后静息与活动时疼痛情况、术后镇痛药物使用情况（包括口服强效镇痛药物和静脉自控镇痛泵的使用情况）、术后活动情况（包括运动恐惧程度、首次下床时间、活动时长及活动方式）和术后睡眠情况（包括连续睡眠时间和睡眠中途疼醒次数）。

研究结果：

1.干预方案的制定

文献分析结果：共纳入9篇文献，得到的证据总结包括指导原则、疼痛评估、药物措施、非药物措施、干预效果评价及健康教育六个方面共25条证据，基于证据总结构建方案初稿。专家函询结果：两轮函询中，专家积极系数均为100％，整体权威系数为0.957；各条目变异系数均值均<0.25；肯德尔协调系数（Kendall's W）显著性检验具有统计学意义。研究者结合专家意见对方案进行修改，形成了最终版的《先天性小耳畸形患儿肋软骨采取术术后疼痛护理干预方案》。干预方案由11个一级指标，21个二级指标，45个三级指标构成；一级指标包括适用人群、干预的基本原则、建立术后疼痛护理干预档案、针对患儿及家长的术后疼痛相关知识宣教、做好患儿术后疼痛的评估、遵医嘱使用镇痛药物、做好患儿术后体位管理、减轻患儿活动时的疼痛、为患儿提供安静舒适的环境、针对患儿及家长的术后镇痛药物相关知识宣教、教会患儿缓解疼痛的其他方法。

2.干预方案的临床应用效果

干预组与对照组各纳入47名患儿。主要结局指标：（1）患儿术后静息时疼痛：1）干预组患儿术后静息时疼痛评分（各评估时间点当时的疼痛评分）低于对照组，差异有统计学意义（P＜0.05）。2）干预组患儿术后静息时疼痛评分（相邻2个评估时间点之间最疼时的疼痛评分）低于对照组，差异有统计学意义（P＜0.05）。（2）患儿术后活动时疼痛：1）干预组患儿术后活动时疼痛评分（各评估时间点当时的疼痛评分）低于对照组，差异有统计学意义（P＜0.05）。2）干预组患儿术后活动时疼痛评分（相邻2个评估时间点之间最疼时的疼痛评分）低于对照组，差异有统计学意义（P＜0.05）。次要结局指标：（1）患儿术后镇痛药物使用情况：干预组患儿口服强效镇痛药物使用次数少于对照组，差异有统计学意义（P＜0.05）。（2）术后活动情况：干预组患儿运动恐惧程度低于对照组患儿，术后首次下床时间早于对照组患儿，术后首次下床活动时长长于对照组，差异有统计学意义（P＜0.05）。（3）患儿术后睡眠情况：干预组患儿术后连续睡眠时间长于对照组患儿，术后睡眠中途疼醒次数少于对照组患儿，差异有统计学意义（P＜0.05）。

研究结论：

1.本研究构建的《耳畸形患儿自体肋软骨采取术术后疼痛护理干预方案》包括术前和术后两个干预阶段。术前阶段确定干预的适用人群及基本原则、为患儿建立术后疼痛护理干预档案、针对患儿及家长做术后疼痛相关知识宣教；术后阶段做好患儿术后疼痛的评估、做好用药护理、体位管理、活动时护理、环境护理、针对患儿及家长做术后镇痛药物相关知识宣教、教会患儿缓解疼痛的其他方法。本干预方案具体、可操作性强。

2.实施方案后，耳畸形患儿术后静息和活动时疼痛评分降低，口服强效镇痛药物使用次数减少，术后运动恐惧程度降低、首次下床时间提前、活动时长增加，术后连续睡眠时长增加、睡眠中途疼醒次数减少。本方案安全有效，值得在临床中进一步的推广实施。

Abstract

Background: Congenital microtia is an abnormality of the external and middle ear caused by the developmental abnormality of the first and second branchial arches and the first branchial groove in the embryonic period. It has the second highest incidence after cleft lip and palate and is one of the most common craniofacial deformity. The current preferred treatment method is ear reconstruction surgery, with the optimal age for surgery being between six and eight years old. The surgical process includes harvesting autologous costal cartilage, carving it into an auricle frame, and implanting the auricle frame under skin to solve the problem of the patient's abnormal appearance. Acute postoperative pain at the chest incision is one of the most common complaints in children. Pain not only causes unpleasant feelings but also affects various systems of the whole organism, so it is important to take effective measures to relieve postoperative pain. At present, more attention is focused on improving analgesics and anesthetic methods to reduce postoperative pain, but it may bring additional costs and invasive operations. Some problems can not be solved only by drug measures, such as the lack of knowledge about pain in children, the aggravation of pain due to inappropriate behavior (such as crying loudly and heaving the chest), and these issues require appropriate nursing measures to intervene. A number of researchers have taken the initiative to alleviate postoperative pain through nursing measures, and the feedback is pretty good. However, there are problems such as a small sample size of the study and a single intervention measure (postural care only). Therefore, it is necessary to construct a scientific, effective, and systematic nursing intervention program for costal cartilage harvest children with congenital microtia.

Objective: Based on the evidence-based approach, combined with expert opinions, a “Postoperative Pain Nursing Intervention Program for Costal Cartilage Harvest children with Congenital Microtia” was formulated; then this program was implemented in the clinical practice to preliminarily test its clinical application effect.

Methods:

1. Construction of the intervention program

The literature analysis method was adopted to systematically retrieve the clinical supporting decision system, clinical practice guidelines, expert consensus, systematic reviews and original studies related to pain intervention of children with congenital microtia. The literature quality evaluation and evidence hierarchy were conducted by the literature quality evaluation criteria and evidence grading standards of AGREE II and JBI. Extract the information related to the intervention of children's pain in the literature included, and form the first draft of the postoperative pain nursing intervention program for costal cartilage harvest children with congenital microtia; the opinions of 12 experts in the fields of microtia diagnosis and treatment, nursing, anesthesia, and nursing education were solicited by Delphi method on the first draft, and the postoperative pain nursing intervention program for costal cartilage harvest children with congenital microtia was finally formed.

2.Evaluation of the clinical effect on intervention program

This study is an quasi-experimental study, convenient sampling method was adopted. The control group consisted of 47 children who underwent costal cartilage harvesting surgery in the ear reconstruction department of a Beijing tertiary grade A hospital from July to September 2024. The intervention group consisted of 47 children who underwent costal cartilage harvesting surgery in the same ward from October to December 2024. The children in the control group received routine nursing care in the ear reconstruction ward. In addition routine nursing care in the ward, the children in the intervention group also received an intervention according to the "Postoperative Pain Nursing Intervention Program for Costal Cartilage Harvest children with Congenital Microtia". Record the pain of children during rest and activity after surgery, the use of analgesics after surgery (Including the use of oral strong analgesics and intravenous patient-controlled analgesia pumps), postoperative activity condition (Including the degree of fear of movement, the time of getting out of bed for the first time, the duration and the way of activities) and postoperative sleep condition (including the continuous sleep time and the number of times of being awakened by pain during sleep).

Results:

1.Construction of the intervention program

Results of literature analysis: A total of 9 articles were included, and 25 pieces of evidence were obtained from six aspects including guiding principles, pain assessment, drug measures, non-drug measures, effect evaluation and health education. Based on the evidence summary, the first draft of the intervention program was constructed. Delphi inquiry results: the positive coefficients of experts were 100%, the authority was 0.957; the mean coefficient of variation of each item was less than 0.25; the Kendall's W test is statistically significant. The researchers modified the program based on the expert opinions and formed the final version of the "Postoperative Pain Nursing Intervention Program for Costal Cartilage Harvest children with Congenital Microtia". The program consists of 11 primary indicators, 21 secondary indicators, and 45 tertiary indicators; the primary indicators include the target population, the basic principles of intervention, the establishment of a postoperative pain intervention file, health education for children and parents on postoperative pain related knowledge, proper assessment of children's postoperative pain, the use of analgesics, proper postoperative body position management, pain reduction during activities, provision of a quiet and comfortable environment, health education for children and parents on postoperative analgesic-related knowledge, and teaching children other methods to relieve pain.

2.Evaluation of the clinical effect on intervention program

Both of the intervention group and the control group included 47 children. Primary outcome indicators: (1) Pain of children during rest: the pain scores of children in the intervention group were lower than those of the control group, at each evaluation time point and at the worst between 2 adjacent assessment points. (2) Pain of children during activity: the pain scores of children in the intervention group were lower than those of the control group, at each evaluation time point and at the worst between 2 adjacent assessment points. Secondary outcome indicators: (1) Use of analgesics after surgery: the number of children in the intervention group who used oral strong analgesics was less than that in the control group. (2) Postoperative activity condition: compared with the control group, children in the intervention group got a lower degree of movement fear, an earlier time of first getting out of bed after surgery, and a longer length of time for the first postoperative ambulation. (3) Postoperative sleep condition: compared with the control group, children in the intervention group had a longer continuous sleep time, and the number of times of being awakened by pain during sleep was less. The above comparison differences were all statistically significant(P＜0.05).

Conclusion:

1.The “Postoperative Pain Nursing Intervention Program for Costal Cartilage Harvest children with Congenital Microtia” in this study includes two intervention stages: preoperative and postoperative. The preoperative stage determines the applicable population and basic principles of the intervention, establishes a postoperative pain intervention file for children, and provides education on postoperative pain-related knowledge for children and their parents. The postoperative stage is to assess the postoperative pain of children, to do drug care, body position management, activity care, environmental care, and to teach children and their parents about postoperative analgesics and other methods to relieve pain.This intervention program is specific and highly operable.

2.After the implementation of the program, the postoperative pain scores of children during rest and activity decreased, the use of oral strong analgesics reduced, children’s degree of movement fear decreased, the time of first getting out of bed after surgery advanced, the duration of the first postoperative ambulation increased, the duration of continuous sleep increased, and the number of times of being awakened by pain during sleep was reduced. This program is safe and effective, and it is worth implementing the program in the clinic.