中文儿科临床试验疼痛评价量表使用情况调查

目的 调查中文儿科RCT疼痛评价量表的使用情况。方法 检索中国生物医学文献数据库、中文科技期刊全文数据库、中国知网和万方数据库，并手工检索9本与儿科或麻醉疼痛相关的中文杂志，检索时间均从建库或创刊至2012年7月。2名评价员独立对检索文献进行筛选，提取纳入RCT使用的疼痛量表及所评价儿童的年龄、疼痛类型等信息。采用频数和百分比进行统计描述。结果共纳入612篇RCT，其中116篇（19.0%）未采用明确的疼痛评价量表。余496篇采用的疼痛评价量表有31个（21个观察性量表和10个自我报告性量表），其中使用最多的3个量表为视觉模拟评分（VAS，26.6%）、FLACC疼痛评价量表（FLACC,9.3%）和新生儿疼痛评价量表（NIPS，6.9%）。19个观察性疼痛评价量表引自国外，仅FLACC被规范化翻译为中文，并对其在儿科人群中的效度和信度进行评价。39篇RCT（6.6%）仅采用自我报告性量表对<3岁儿童的疼痛程度进行评价。结论 约1/4中文RCT未规范使用疼痛评价量表，可能误导儿童疼痛的治疗。鉴于中国使用的疼痛评价量表多来自国外，建议今后应对国外疼痛评价量表按照相关指南进行改编，并行效度和信度评价，对量表适用年龄及疼痛类型做出推荐。

Frequency and use of pain assessment scales in Chinese clinical trials in pediatric population

Objective To survey the the application of pain scales in Chinese randomized controlled trials （RCTs） for assessing children＇s pain. Methods Four Chinese medical databases, including Chinese Biomedicine Literature Database were searched using the search terms ＂ child＂ , ＂ pediatrics＂ , ＂ infant＂ , ＂ child,＂ ＂ pain＂ and ＂ randomized＂ in July 2012. Nine journals were hand-searched in case of missing study. RCTs that assessed children＇s pain intensity as an outcome were included. Information of included RCTs, such as pain scales and children＇s ages were extracted. Meta analyst 3.13 and Excel 2010 were used to analyze data. Results A total of 612 RCTs were included, of which 116 （19.0%） had not used a specific pain scale. 31 pain scales, including 21 observational scales and 10 self-reported scales, were identified in the remaining 496 RCTs. The three most frequently used pain scales were VAS （Visual Analog Scale; 26.6% ） , FLACC （face, legs, arms, cry, consolability; 9.3% ） and NIPS （ neonatal infant pain scale ; 6.9% ）. Nineteen observational pain scales were originally developed in non-Chinese, but only one （FLACC） was translated into Chinese following recommended approaches. 39 RCTs （6.6%） used self-reported pain scales to assess children under 3 years old. Conclusions More than 25% of the Chinese RCTs had not assessed children＇s pain intensity properly. As most pain scales used in China were originally developed in other language, they should be translated into Chinese and adapted following recommended approaches. The validation of Chinese versions should be assessed, and consumers should be trained in how to use them.