Gan Kimberly M L, Oei Ju-Lee, Quah-Smith Im, Kamar Azanna A, Lordudass Alexis A D, Liem Kian D, Lindrea Kwee Bee, Daly Mary, Gaunker Nilima, Mangat Avneet K, Yaskina Maryna, Schmölzer Georg M
Faculty of Medicine, University of New South Wales, Kensington, NSW, Australia.
School of Women's and Children's Health, University of New South Wales, Kensington, NSW, Australia.
Front Pediatr. 2020 Dec 23;8:615008. doi: 10.3389/fped.2020.615008. eCollection 2020.
Eye exam for Retinopathy of prematurity (ROP) is a painful procedure and pharmacological analgesia might be ineffective. We hypothesized that magnetic auricular acupuncture (MAA) compared to placebo will decrease pain during ROP exam in preterm infants. Multicentre randomized controlled trial conducted in three hospitals (Australia, Canada, and Malaysia). Eligibility: >32 weeks, ROP exam, not sedated, and parental consent. A total of 100 infants were randomized (1:1) to MAA ( = 50) or placebo ( = 50). MAA stickers or placebo were placed on both ears by an unblinded investigator. Pain was assessed using the Premature Infant Pain Profile. Primary analyses were by intention-to-treat. ClinicalTrials.gov:NCT03650621. The mean (standard deviation, SD) gestation, birthweight, and postnatal age were (MAA 28(3) vs. placebo 28(2) weeks; MAA 1,057(455) vs. placebo 952(273) g; MAA 7(3) vs. placebo 7(3) weeks. Placebo infants had significantly higher PIPP scores during [mean difference 1.6 points (95%CI 0.1-3.1)] and 1 h mean difference 1.5 points (95%CI 0.7-2.2) after the procedure ( < 0.03). Heart rate was lower (173(22) vs. 184(18)/min) and oxygen saturations were higher (93.8(6.2) vs. 91.7(6.1)%, = 0.05) in MAA infants. No adverse effects. MAA may reduce physiological pain responses during and after ROP exam in preterm infants. Assessment of long-term effects are warranted. : www.ClinicalTrials.gov, identifier: NCT03650621.
早产儿视网膜病变（ROP）的眼部检查是一个痛苦的过程，药物镇痛可能无效。我们假设，与安慰剂相比，磁耳针（MAA）将减轻早产儿ROP检查期间的疼痛。在三家医院（澳大利亚、加拿大和马来西亚）进行的多中心随机对照试验。入选标准：孕周>32周、ROP检查、未镇静且获得家长同意。总共100名婴儿被随机分组（1:1）至MAA组（n = 50）或安慰剂组（n = 50）。由未设盲的研究者在双耳放置MAA贴纸或安慰剂。使用早产儿疼痛量表评估疼痛。主要分析采用意向性分析。ClinicalTrials.gov标识符：NCT03650621。平均（标准差，SD）孕周、出生体重和出生后年龄分别为（MAA组28（3）周 vs. 安慰剂组28（2）周；MAA组1057（455）g vs. 安慰剂组952（273）g；MAA组7（3）周 vs. 安慰剂组7（3）周。安慰剂组婴儿在检查期间[平均差异1.6分（95%CI 0.1 - 3.1）]及检查后1小时[平均差异1.5分（95%CI 0.7 - 2.2）]的早产儿疼痛量表得分显著更高（P<0.03）。MAA组婴儿心率较低（173（22）次/分钟 vs. 184（18）次/分钟），血氧饱和度较高（93.8（6.2）% vs. 91.7（6.1）%，P = 0.05）。无不良反应。MAA可能减轻早产儿ROP检查期间及检查后的生理疼痛反应。有必要评估其长期影响。网址：www.ClinicalTrials.gov，标识符：NCT03650621。
