作為“臨床試驗中對受試者疼痛管理的倫理考慮”系列標準之一，主要論述《兒科人群臨床試驗中對受試者疼痛管理的倫理考慮》的起草背景、制定依據(jù)和適用范圍，以及兒科人群臨床試驗中受試者疼痛等負擔的來源和識別、在兒科人群臨床試驗方案設計和臨床試驗執(zhí)行過程時使受試者疼痛最小化的措施，以期從倫理角度對兒科人群臨床試驗中受試者疼痛管理提出指導意見。其適用于倫理審查中對于兒科人群臨床試驗中受試者疼痛管理的倫理考慮，以及研究者制定臨床試驗方案和試驗流程對兒科人群疼痛管理的關注。對臨床試驗中兒科人群疼痛予以更多關注，是保護兒科受試者權益的措施之一，有助于保障兒科臨床試驗順利開展。

As part of the "Ethical considerations for subject pain management in clinical trials" series, this paper mainly discusses the drafting background, formulation basis and application scope of the standard "Ethical considerations for subject pain management in pediatric population clinical trials", as well as the main source and identification of the burden of pain in pediatric clinical trials, measures to minimize pain in the design of clinical trial protocols and in the execution of clinical trials in pediatric populations, in order to provide guidance for pain management of subjects in pediatric clinical trials from the ethical perspective. It is applicable to the ethical consideration of pain management in clinical trials in pediatric population in ethical review, as well as the concern of researchers on pain management in the development of clinical trial protocol and trial procedure in pediatric. It is one of the measures to protect the rights and interests of pediatric subjects to pay more attention to the pain of pediatric subjects in clinical trials, which is helpful to ensure the smooth development of pediatric clinical trials.

R926

國家“十三五”重大新藥創(chuàng)制專項課題（2019ZX09734001）；北京醫(yī)學倫理學會科研課題（BMEA2021105）