磁刺激无针针灸治疗婴儿舒适度(MAGNIFIC) - 一项单盲随机对照先导试验。

Magnetic noninvasive acupuncture for infant comfort (MAGNIFIC) - a single-blinded randomised controlled pilot trial.

机构信息

School of Women's and Children's Health, University of New South Wales, Kensington, NSW, Australia.

Department of Newborn Care, The Royal Hospital for Women, Randwick, NSW, Australia.

出版信息

Acta Paediatr. 2017 Nov;106(11):1780-1786. doi: 10.1111/apa.14002. Epub 2017 Aug 29.

Abstract

AIM

To determine the safety and feasibility of auricular noninvasive magnetic acupuncture (MA) to decrease infant pain during heel pricks.

METHODS

Infants requiring heel pricks for blood collection were randomised to either MA (n = 21) or placebo (P) (n = 19) after parental informed consent. MA or placebo stickers were placed on both ears according to the Battlefield Protocol by an unblinded investigator and left on for 3 days. Pain was assessed with the Premature Infant Pain Profile (PIPP) by blinded clinicians.

RESULTS

Mean gestation (MA:34.1, P:34.4 weeks) and age of infants (MA:5.3, P:4.5 days) were similar as were mean (SD) pre (MA:1.7(1.4), P:2.1(1.9)) and post (MA:1.6(1.4), P: 2.1(1.7)) heel prick PIPP scores. PIPP scores were significantly lower in MA infants during heel pricks (MA:5.9(3.7), P: 8.3(4.7), p = 0.04). One-way ANCOVA modelling showed that MA was significantly associated with lower PIPP scores after controlling for analgesic use (p = 0.043). No differences in heart rate, oxygen saturation, analgesic use or adverse effects (e.g. local skin reactions) noted.

CONCLUSION

This pilot study shows that auricular MA is feasible in neonates and may reduce PIPP scores during heel pricks. Further study is required to determine the impact of MA on other painful or stressful conditions and on neurodevelopment.

摘要

目的

确定耳无创磁刺激(MA)在减少足跟采血时婴儿疼痛中的安全性和可行性。

方法

在获得父母知情同意后,将需要足跟采血的婴儿随机分为 MA 组(n=21)或安慰剂(P)组(n=19)。根据战场方案,未设盲的研究者将 MA 或安慰剂贴片贴于耳上,并保留 3 天。由设盲的临床医生使用早产儿疼痛评估工具(PIPP)评估疼痛。

结果

平均胎龄(MA:34.1 周,P:34.4 周)和婴儿年龄(MA:5.3 天,P:4.5 天)相似,足跟采血前(MA:1.7(1.4),P:2.1(1.9))和足跟采血后(MA:1.6(1.4),P:2.1(1.7))的 PIPP 评分也相似。在足跟采血过程中,MA 组婴儿的 PIPP 评分显著降低(MA:5.9(3.7),P:8.3(4.7),p=0.04)。单向方差分析模型显示,在控制使用镇痛药的情况下,MA 与较低的 PIPP 评分显著相关(p=0.043)。未观察到心率、血氧饱和度、镇痛药使用或不良反应(如局部皮肤反应)的差异。

结论

这项初步研究表明,新生儿耳 MA 是可行的,可能会降低足跟采血时的 PIPP 评分。需要进一步研究以确定 MA 对其他疼痛或应激状态以及神经发育的影响。

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