Taddio Anna, Riddell Rebecca Pillai, Ipp Moshe, Moss Steven, Baker Stephen, Tolkin Jonathan, Dave Malini, Feerasta Sharmeen, Govan Preeya, Fletcher Emma, Wong Horace, McNair Caitlin, Mithal Priyanjali, Stephens Derek
Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada; Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.
Department of Psychology, York University, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
J Pain. 2017 Sep;18(9):1060-1066. doi: 10.1016/j.jpain.2017.04.002. Epub 2017 Apr 26.
The objective was to determine if consistent pain management during vaccine injections has a beneficial effect on future infant pain reactivity. This was a multicenter, longitudinal, double-blind, double-dummy, add-on, randomized controlled trial. Healthy infants were randomized to 1 of 4 add-on pain management regimens for all vaccinations in the first year of life: 1) placebo control (standard care), 2) parent video education about infant soothing (video), 3) video and oral sucrose solution (sucrose), 4) video and sucrose and topical liposomal lidocaine (lidocaine). At 15-month vaccinations, all active pain interventions were administered (video and sucrose and lidocaine); however, individuals remained blinded to the original treatments given. Pain at 15 months was evaluated during 3 procedure phases (baseline, needle injection, and recovery) by a researcher unaware of group allocation using a validated measure, the Modified Behavioural Pain Scale (range, 0-10). Altogether, 352 infants participated; characteristics did not differ among groups (P > .05). Pain scores did not differ among groups during baseline (P = .642), needle injection (P = .739), or recovery (P = .750) phases. In conclusion, there was no evidence of a long-term benefit of consistent use of pain interventions in the first year of life on future infant pain responsivity at 15-month vaccinations.
This randomized controlled trial did not find a long-term benefit of consistent pain management during infant vaccinations on future infant pain responsivity at 15 months. The results are relevant to clinicians and researchers studying and evaluating pain interventions in children undergoing medical procedures.
目的是确定疫苗注射期间持续的疼痛管理对未来婴儿疼痛反应性是否有有益影响。这是一项多中心、纵向、双盲、双模拟、附加、随机对照试验。健康婴儿在出生后第一年的所有疫苗接种中被随机分配到4种附加疼痛管理方案中的一种：1）安慰剂对照（标准护理），2）关于安抚婴儿的家长视频教育（视频），3）视频和口服蔗糖溶液（蔗糖），4）视频、蔗糖和局部脂质体利多卡因（利多卡因）。在15个月龄疫苗接种时，所有积极的疼痛干预措施均被实施（视频、蔗糖和利多卡因）；然而，个体仍对最初给予的治疗不知情。在15个月龄时，由一名不知道分组情况的研究人员使用经过验证的量表——改良行为疼痛量表（范围为0至10），在3个操作阶段（基线、针头注射和恢复）评估疼痛情况。共有352名婴儿参与；各组之间的特征无差异（P>.05）。在基线阶段（P=.642）、针头注射阶段（P=.739）或恢复阶段（P=.750），各组的疼痛评分无差异。总之，没有证据表明在出生后第一年持续使用疼痛干预措施对15个月龄疫苗接种时未来婴儿的疼痛反应性有长期益处。
这项随机对照试验未发现婴儿接种疫苗期间持续的疼痛管理对15个月龄时未来婴儿疼痛反应性有长期益处。该结果与研究和评估接受医疗程序儿童疼痛干预措施的临床医生和研究人员相关。
