【罂粟摘要】纳布啡降低儿童腺样体扁桃体切除术后苏醒期躁动的发生率:一项前瞻性、随机、双盲、多中心研究

纳布啡降低儿童腺样体扁桃体切除术后苏醒期躁动的发生率:一项前瞻性、随机、双盲、多中心研究  

贵州医科大学      麻醉与心脏电生理课题组

翻 译：潘志军   编 辑：柏雪   审 校：曹莹

背景：探讨纳布啡对腺样体扁桃体切除术后患儿出现苏醒期躁动(EA)的影响。

实验设计：多中心、前瞻性、双盲、随机对照试验。

范围设置：2020年4月至2021年12月，佛山第一人民医院和中国其他三家合作医院。

受试者：800例，年龄3-9岁，美国麻醉医师协会(ASA)分类I或II级，接受择期腺样体扁桃体切除术的儿童。

干预措施：静脉注射纳布啡(0.1 mg/kg)或生理盐水。

测量方法：EA发生率，儿童麻醉苏醒期谵妄量表(PAED)，以及面部、腿部、活动、哭泣和可安慰性 (FLACC) 量表。拔管时间、麻醉后监护室(PACU)停留时间、麻醉护士和家长满意度及其他不良反应。

结果：拔管后30 min，纳布啡组EA发生率低于生理盐水组(10.28% vs. 28.39%， P = 0.000)。拔管后30min，纳布啡组FLACC评分低于生理盐水组(P < 0.05)。此外，纳布啡组中至重度疼痛病例的比例(FLACC评分>3)明显低于生理盐水组(33.58% vs. 60.05%，P = 0.000)。对术后疼痛强度不均进行调整后，纳布啡组在0分钟（OR，0.39；95%CI，0.26-0.60；P=0.000），（OR，优势比；CI，可信区间）；10分钟（OR，0.39；95%CI，0.19~0.79；P=0.01）；20分钟（OR，0.27；95%CI，0.08~0.99；P=0.046）的EA风险仍低于生理盐水组。两组拔管时间、PACU停留时间、恶心呕吐、呼吸抑制比较差异均无统计学意义(P > 0.05)。

结论：纳布啡可降低全麻下腺样体扁桃体切除术后儿童EA的发生率，EA可能通过镇痛和非镇痛两种途径发生。

原始文献来源：Jian He,Lei Zhang, Tao Tao,et al.Nalbuphine reduces the incidence of emergence agitation in children undergoing Adenotonsillectomy: A prospective, randomized, double-blind, multicenter study [J]. (J Clin Anesth. 2023May;85:111044).

英文原文：

Nalbuphine reduces the incidence of emergence agitation in children undergoing Adenotonsillectomy: A prospective, randomized, double-blind, multicenter study     

Abstract

Study objective: To evaluate the effect of nalbuphine on emergence agitation (EA) in children undergoing adenotonsillectomy.

Design: Multicenter, prospective, double-blind, randomized controlled trial.

Setting: The First People’s Hospital of Foshan and three other participating institutions in China, from April 2020 to December 2021.

Patients: Eight hundred patients, 3–9 years of age, American Society of Anesthesiologists (ASA) classification I or II, undergoing elective adenotonsillectomy were included.

Interventions: Nalbuphine (0.1 mg/kg) or saline was administered intravenously.

Measurements: The incidence of EA; the pediatric anesthesia emergence delirium (PAED) scale; and the faces, legs, activity, cry, and consolability (FLACC) scales. Extubation time, duration of post-anesthesia care unit (PACU) stay, anesthesia nurses’ and parents’ satisfaction, and other side effects.

Main results: The incidence of EA in the nalbuphine group was lower than that in the saline group 30 min after extubation (10.28% vs. 28.39%, P = 0.000). In addition, the FLACC scores in the nalbuphine group were lower than those in the saline group 30 min after extubation (P < 0.05). Furthermore, the proportion of moderate-to-severe pain cases (FLACC scores >3) was significantly lower in the nalbuphine group than in the saline group (33.58% vs. 60.05%, P = 0.000). Adjusting the imbalance of postoperative pain intensity, the risk of EA was still lower in the nalbuphine group at 0 min (OR, 0.39; 95% CI, 0.26–0.60; P = 0.000), (OR, odds ratio; CI, confidence interval), 10 min (OR, 0.39; 95% CI, 0.19–0.79; P = 0.01), and 20 min (OR,

0.27; 95% CI, 0.08–0.99; P = 0.046) than in the saline group. There were no significant differences in extubation time, duration of PACU stay, nausea and vomiting, or respiratory depression between the two groups (P > 0.05).

Conclusion: Nalbuphine reduced the incidence of EA in children after adenotonsillectomy under general anesthesia, which may be involved in both analgesic and non-analgesic pathways.

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