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术中美沙酮对行睾丸固定术的儿童术后阿片类药物需求的影响:一项随机临床试验。

The effect of intraoperative methadone on postoperative opioid requirements in children undergoing orchiopexy: A randomized clinical trial.

机构信息

Department of Anesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.

出版信息

Paediatr Anaesth. 2024 Dec;34(12):1250-1257. doi: 10.1111/pan.15009. Epub 2024 Sep 22.

DOI:10.1111/pan.15009
PMID:39306760
Abstract

BACKGROUND

Children undergoing outpatient surgery are at risk of inadequate postoperative pain control. Methadone has a long duration of action and an intraoperative dose may provide stable analgesia throughout the postoperative period. Intraoperative methadone has been shown to improve pain control in adolescents but its use for postoperative pain in pediatric patients undergoing outpatient surgery has not been studied before. Therefore, we conducted a double-blind randomized placebo-controlled trial to investigate the effects of a single dose of intraoperative methadone in children aged less than 5 years undergoing orchiopexy for undescended testis.

METHODS

A total of 68 children were randomized to receive either methadone (0.1 mg/kg) or isotonic saline following induction of anesthesia. Exclusion criteria included preterm birth, previous scrotal surgery, and parents' inability to consent. Primary outcomes were opioid requirements (first primary outcome) and pain intensity in the post-anesthesia care unit. Secondary outcomes included episodes of desaturation and time until readiness to discharge from the post-anesthesia care unit, sleep on the first postoperative night, pain intensity, and opioid requirements at home until the evening on the first postoperative day. Follow-up was 4 days.

RESULTS

Sixty children completed the study (age, mean ± SD, 26.2 ± 13.9 months), 29 children received methadone, and 31 children received placebo. Eighteen children required opioids in the post-anesthesia care unit, five children in the methadone group (proportion = 0.17, 95% confidence interval (CI): 0.07, 0.36) compared to thirteen patients in the placebo group (0.42, 95% CI: 0.26, 0.60) (mean difference = -0.24 and 95% CI: -0.03, -0.47) (p = 0.037). Five children in the methadone group (0.17, 95% CI: 0.03, 0.31) versus ten in the placebo group (0.32, 95% CI: 0.16, 0.49) had a face, legs, activity, cry, consolability score of ≥5 in the post-anesthesia care unit (mean difference = -0.15, 95% CI: -0.36, 0.06) (p = .179). More children in the placebo group woke up due to pain the first night following surgery (seven children vs. one child). The methadone group had a longer stay in the post-anesthesia care unit. There were no differences between the two groups regarding the other secondary outcomes.

CONCLUSION

A single dose of intraoperative methadone reduces short-term postoperative opioid requirements in children after orchiopexy for nondescended testes but prolongs the duration of their stay in the post-anesthesia care unit.

摘要

背景

接受门诊手术的儿童存在术后疼痛控制不足的风险。美沙酮作用时间长,术中给予剂量可能在整个术后期间提供稳定的镇痛效果。术中给予美沙酮已被证明可改善青少年的疼痛控制,但在接受门诊手术的儿科患者中,其用于术后疼痛的效果尚未得到研究。因此,我们进行了一项双盲随机安慰剂对照试验,以研究接受隐睾固定术的 5 岁以下儿童术中给予单次美沙酮对术后疼痛的影响。

方法

共 68 名儿童随机分为接受美沙酮(0.1mg/kg)或等渗盐水组,在诱导麻醉后。排除标准包括早产、以前的阴囊手术和父母无法同意。主要结局是术后阿片类药物需求(主要结局 1)和术后护理中心的疼痛强度。次要结局包括脱氧发作和从术后护理中心出院的时间、第一个术后晚上的睡眠、疼痛强度以及第一个术后日傍晚前的阿片类药物需求。随访 4 天。

结果

60 名儿童完成了研究(年龄,平均值±标准差,26.2±13.9 个月),29 名儿童接受美沙酮,31 名儿童接受安慰剂。18 名儿童在术后护理中心需要阿片类药物,美沙酮组 5 名(比例=0.17,95%置信区间(CI):0.07,0.36),而安慰剂组 13 名(0.42,95%CI:0.26,0.60)(平均差值=-0.24,95%CI:-0.03,-0.47)(p=0.037)。美沙酮组 5 名儿童(0.17,95%CI:0.03,0.31)和安慰剂组 10 名儿童(0.32,95%CI:0.16,0.49)在术后护理中心有≥5 分的面部、腿部、活动、哭声、安抚性评分(平均差值=-0.15,95%CI:-0.36,0.06)(p=0.179)。更多的安慰剂组儿童在手术后的第一个晚上因疼痛醒来(7 名儿童对 1 名儿童)。美沙酮组在术后护理中心的停留时间更长。两组在其他次要结局方面没有差异。

结论

隐睾固定术的儿童术中单次给予美沙酮可减少术后短期阿片类药物需求,但延长其在术后护理中心的停留时间。

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