Kaszyński Maciej, Kuczerowska Alicja, Pietrzyk Justyna, Sawicki Piotr, Witt Paweł, Stankiewicz Barbara, Darowski Marek, Pągowska-Klimek Izabela
Department of Paediatric Anaesthesiology and Intensive Care, Medical University of Warsaw University Clinical Centre, ul. Żwirki i Wigury 63A, Warsaw, 02-091, Poland.
Polish Medical Air Rescue, Warsaw, Poland.
BMC Anesthesiol. 2025 Jan 10;25(1):23. doi: 10.1186/s12871-024-02885-z.
Lidocaine, a widely used local anaesthetic, also serves as an adjuvant in pain management. However, its use in children is off-label. This study aimed to determine if intravenous lidocaine alleviates the haemodynamic, metabolic, and hormonal responses to intubation and laparoscopic surgery in children.
A single-centre, parallel, double-masked, randomised, placebo-controlled trial. 132 patients, aged 18 months to 18 years, with no contraindications to lidocaine administration and qualified for laparoscopic appendectomy were enrolled. The intervention studied was a lidocaine bolus of 1.5 mg⋅kg over 5 min given before induction of anaesthesia, followed by intraoperative lidocaine infusion at 1.5 mg⋅kg⋅h intraoperatively. Patients in the control group were administered a placebo. Mean arterial pressure, glucose, cortisol, lidocaine blood levels, lidocaine-related side effects, and intraoperative opioid requirements were analysed.
132 participants completed the trial. The number of patients who experienced an excessive cardiovascular response to induction of anaesthesia or intubation was 23 (37%) in the control group and 21 (34%) in the lidocaine group (p = 0.707). No statistically significant difference was found between the control and lidocaine groups in the hormonal and metabolic responses, as well as intraoperative fentanyl requirements. Serum lidocaine levels remained below the toxic threshold in all patients.
Although the studied intervention appears to be safe, with no clinical side effects observed and serum lidocaine levels remaining below the toxic threshold, its intraoperative administration is not recommended, as it does not demonstrate any significant benefit during the anaesthesia period when compared to placebo.
NCT05238506. The date of first registration: 14/02/2022.
利多卡因是一种广泛使用的局部麻醉剂，也用作疼痛管理的辅助药物。然而，其在儿童中的使用属于超说明书用药。本研究旨在确定静脉注射利多卡因是否能减轻儿童气管插管和腹腔镜手术时的血流动力学、代谢及激素反应。
一项单中心、平行、双盲、随机、安慰剂对照试验。纳入132例年龄在18个月至18岁之间、无利多卡因给药禁忌且符合腹腔镜阑尾切除术条件的患者。研究的干预措施是在麻醉诱导前5分钟静脉推注1.5mg·kg利多卡因，随后术中以1.5mg·kg·h的速度输注利多卡因。对照组患者给予安慰剂。分析平均动脉压、血糖、皮质醇、利多卡因血药浓度、利多卡因相关副作用及术中阿片类药物需求量。
132名参与者完成了试验。对照组中对麻醉诱导或气管插管出现过度心血管反应的患者有23例（37%），利多卡因组有21例（34%）（p = 0.707）。对照组和利多卡因组在激素和代谢反应以及术中芬太尼需求量方面未发现统计学上的显著差异。所有患者的血清利多卡因水平均低于中毒阈值。
尽管所研究的干预措施似乎是安全的，未观察到临床副作用且血清利多卡因水平低于中毒阈值，但不建议术中使用，因为与安慰剂相比，其在麻醉期间未显示出任何显著益处。
NCT05238506。首次注册日期：2022年2月14日。
