Background Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients. Sedation/analgesia in PICU is usually achieved through various analgesics and sedatives. Excessive use of these drugs can put patients at risk for hemodynamic/respiratory instability, prolonged ventilation, withdrawal, delirium, and critical illness polyneuromyopathy.The use of non-pharmacologic interventions has been recommended by sedation guidelines. However, non-pharmacological measures in PICU, including music and noise reduction, have been inadequately studied. Methods The Music Use for Sedation in Critically ill Children (MUSiCC trial) pilot study is an investigator-initiated, three-arm, randomized controlled trial (RCT) on the use of music for sedation in PICU. The main goal of the study is to demonstrate feasibility of a music trial in PICU and to obtain the necessary information to plan a larger trial. The study compares music versus noise cancelation versus control in sedated and mechanically ventilated children admitted to PICU. In the music group, children receive the music (modified classical music) three times a day for 30 min at a time. Music is delivered with noise cancelation headphones. The noise cancelation group receives the same intervention but with a no music (sham playlist). The control group receives usual care with no specific intervention. Children remain in the study until extubation or a maximum of 7 days. The primary outcomes of the study are feasibility and sedation/analgesia requirements. Secondary outcomes include change in vital signs before and during the intervention, ICU delirium, and adverse effects related to the intervention. The estimated sample size is 20 subjects per group for a total of 60 children. Discussion Despite being recommended by current guidelines, evidence to support the use of music in PICU is lacking. Music has the potential to reduce sedation requirements and their negative side effects. This pilot RCT will demonstrate feasibility and provide the necessary information to plan a larger trial focusing on the effectiveness of the intervention. Trial registration The study was registered at ClinicalTrials.gov (NCT03497559) on April 13, 2018.

中文翻译：

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危重儿童使用音乐进行镇静（MUSiCC 试验）：试验性随机对照试验的研究方案。

背景 疼痛和焦虑引起的压力在儿科重症监护病房 (PICU) 患者中很常见。PICU中的镇静/镇痛通常通过各种镇痛剂和镇静剂来实现。过度使用这些药物会使患者面临血流动力学/呼吸不稳定、长期通气、戒断、谵妄和危重病多发性神经肌病的风险。镇静指南建议使用非药物干预。然而，PICU 中的非药物措施，包括音乐和降噪，尚未得到充分研究。方法 危重儿童音乐镇静（MUSiCC 试验）试点研究是一项由研究者发起的关于在 PICU 中使用音乐进行镇静的三组随机对照试验 (RCT)。该研究的主要目标是证明在 PICU 中进行音乐试验的可行性，并获得必要的信息来计划更大的试验。该研究比较了入住 PICU 的镇静和机械通气儿童的音乐与噪音消除与控制。在音乐组中，孩子们每天接受 3 次音乐（改良古典音乐），每次 30 分钟。音乐通过降噪耳机传送。降噪组接受相同的干预，但没有音乐（假播放列表）。对照组接受常规护理，没有具体干预。儿童留在研究中直到拔管或最多 7 天。该研究的主要结果是可行性和镇静/镇痛要求。次要结果包括干预前和干预期间生命体征的变化，ICU 谵妄，以及与干预相关的不良反应。估计样本量为每组 20 名受试者，总共 60 名儿童。讨论 尽管当前指南推荐，但缺乏支持在 PICU 中使用音乐的证据。音乐有可能减少镇静剂的需求及其负面影响。该试点 RCT 将证明可行性并提供必要的信息来规划一项侧重于干预有效性的大型试验。试验注册 该研究于 2018 年 4 月 13 日在 ClinicalTrials.gov (NCT03497559) 注册。音乐有可能减少镇静剂的需求及其负面影响。该试点 RCT 将证明可行性并提供必要的信息来规划一项侧重于干预有效性的大型试验。试验注册 该研究于 2018 年 4 月 13 日在 ClinicalTrials.gov (NCT03497559) 注册。音乐有可能减少镇静剂的需求及其负面影响。该试点 RCT 将证明可行性并提供必要的信息来规划一项侧重于干预有效性的大型试验。试验注册 该研究于 2018 年 4 月 13 日在 ClinicalTrials.gov (NCT03497559) 注册。