Department of Traumatology and Orthopaedics, University Hospital Split, Split, Croatia.
Department of Pediatrics, University Hospital Split, Split, Croatia.
Eur J Pain. 2019 Feb;23(2):389-396. doi: 10.1002/ejp.1313. Epub 2018 Sep 21.
We analysed outcome domains and pain outcome measures in randomized controlled trials of interventions for postoperative pain management in children and adolescents and compared them to the core outcome set recommended by the Pediatric Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (PedIMMPACT).
Systematic literature search was conducted in MEDLINE, CDSR, DARE, CINAHL and PsycINFO up to 31 January 2017. One author extracted data and second verified the extraction. Outcome domains and pain outcome measures were analysed and compared with the PedIMMPACT core outcome set.
We included 337 trials. Median number of reported outcomes was five (range 1-11) for the included trials and two (range 0-6) for PedIMMPACT. The most commonly analysed PedIMMPACT outcome domains were pain intensity (93%) and "symptoms and adverse events" (83%). The remaining four PedIMMPACT outcomes were present in under 30% of included randomized controlled trials. Proportion of PedIMMPACT outcome domains did not change after the PedIMMPACT was published in 2008. Of the 312 trials that reported pain intensity, 303 (97%) also specified pain assessment tools, in which the most common was the visual analogue scale (24%) followed by the Children's Hospital of Eastern Ontario Pain Scale (18%).
Analysed trials about interventions for pediatric postoperative pain insufficiently used the recommended core outcome set for acute pain in children. Relevance of the PedIMMPACT core outcome set, as well as the reasons behind its limited uptake, need to be further evaluated.
Recommended core outcomes have been insufficiently used in randomized controlled trials about postoperative pain in children, which hinders comparability of studies and makes synthesis of evidence difficult.
我们分析了儿童和青少年术后疼痛管理干预措施的随机对照试验中的结局领域和疼痛结局测量指标，并将其与儿科临床试验方法、测量和疼痛评估倡议（PedIMMPACT）推荐的核心结局集进行了比较。
系统检索了 MEDLINE、CDSR、DARE、CINAHL 和 PsycINFO 中的文献，检索时间截至 2017 年 1 月 31 日。一位作者提取数据，另一位作者对提取结果进行了验证。分析了结局领域和疼痛结局测量指标，并与 PedIMMPACT 核心结局集进行了比较。
我们纳入了 337 项试验。纳入试验报告的结局数量中位数为 5 项（范围 1-11 项），而 PedIMMPACT 为 2 项。最常分析的 PedIMMPACT 结局领域是疼痛强度（93%）和“症状和不良反应”（83%）。其余 4 个 PedIMMPACT 结局在纳入的随机对照试验中不足 30%。2008 年发布 PedIMMPACT 后，PedIMMPACT 结局的比例没有变化。在报告疼痛强度的 312 项试验中，303 项（97%）还指定了疼痛评估工具，其中最常见的是视觉模拟量表（24%），其次是东安大略儿童医院疼痛量表（18%）。
分析的干预儿童术后疼痛的试验对儿童急性疼痛的推荐核心结局集使用不足。需要进一步评估 PedIMMPACT 核心结局集的相关性及其采用有限的原因。
推荐的核心结局在儿童术后疼痛的随机对照试验中使用不足，这阻碍了研究的可比性，并使证据综合变得困难。
