Objective To assess the effect of a non-noxious vibratory stimulus on noxious-evoked cortical responses to skin puncture and to determine whether the presence of certain behavioural components may be used to predict such cortical responses. Design Randomised controlled trial. Setting Level IV neonatal intensive care unit at a stand-alone children’s hospital. Patients 134 hospitalised infants between 36 and 52 weeks’ postmenstrual age and ordered to receive a clinically required laboratory draw. Interventions Infants randomised to receive the intervention, a vibratory stimulus at the site of skin puncture beginning 10 s prior to a heel stick, or the control, no vibration. Main outcome measures Electroencephalography and video recording time-locked to the deployment of the lancet for the skin puncture. Noxious-evoked cortical responses were measured by the area under the curve in the somatosensory region contralateral to the skin puncture. Behavioural responses were coded through video analysis. Results Noxious-evoked cortical responses were significantly reduced in participants receiving the vibratory stimulus compared with the control (frontal, p<0.0001; central, p = 0.0088; central-parietal, p = 0.0111). There were no significant differences in behavioural responses between groups (all p>0.05). Conclusions A non-noxious vibratory stimulus presented prior to and continuing simultaneously with skin puncture significantly mitigates nociception in hospitalised infants. The presence or absence of facial expression components is inadequate to reliably predict pain signalling in the brain. Trial registration number [NCT04050384][1]. Data are available upon reasonable request. Data available on request to corresponding author due to privacy restrictions. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04050384&atom=%2Ffetalneonatal%2Fearly%2F2024%2F03%2F13%2Farchdischild-2023-326588.atom

中文翻译：

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基于振动的缓解新生儿和婴儿皮肤穿刺有害诱发反应：一项随机对照试验

目的 评估无害性振动刺激对皮肤穿刺造成的有害性皮质反应的影响，并确定某些行为成分的存在是否可用于预测此类皮质反应。设计随机对照试验。在独立儿童医院设置四级新生儿重症监护病房。患者134名住院婴儿，月经后年龄在36至52周之间，并被要求接受临床所需的实验室抽检。干预措施 婴儿随机接受干预，即在脚后跟刺穿前 10 秒开始在皮肤穿刺部位进行振动刺激，或接受对照，无振动。主要结果测量脑电图和视频记录，时间锁定为皮肤穿刺的刺血针的部署。通过皮肤穿刺对侧体感区域的曲线下面积来测量伤害性诱发的皮质反应。通过视频分析对行为反应进行编码。结果与对照组相比，接受振动刺激的参与者的有害诱发皮质反应显着降低（额叶，p<0.0001；中枢，p = 0.0088；中央顶叶，p = 0.0111）。各组之间的行为反应没有显着差异（均p>0.05）。结论 在皮肤穿刺之前和同时持续的无害振动刺激可显着减轻住院婴儿的伤害感受。面部表情成分的存在或不存在不足以可靠地预测大脑中的疼痛信号。试用注册号[NCT04050384][1]。数据可根据合理要求提供。由于隐私限制，可根据通讯作者的要求提供数据。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04050384&atom=%2Ffetalneonatal%2Fearly%2F2024%2F03%2F13%2Farchdischild-2023-326588.atom