Department of Anesthesiology, University of Michigan Health System, Ann Arbor, MI, USA.
Department of Urology, University of Michigan Health System, Ann Arbor, MI, USA.
Paediatr Anaesth. 2022 Oct;32(10):1151-1158. doi: 10.1111/pan.14517. Epub 2022 Jul 12.
This study's purpose was to determine if ondansetron can prevent pruritus after administration of intrathecal morphine in children, as has been demonstrated in adults.
A double-blinded, randomized placebo-controlled trial.
Operating room and first 24 h postoperative inpatient stay at an academic children's hospital.
Forty-six children aged 3-17 years, who received 4-5 mcg/kg intrathecal morphine for urological or orthopedic procedures were included.
Children were randomized to receive intravenous ondansetron (treatment) or saline placebo (placebo), prior to intrathecal morphine administration, and q6H for 24 h thereafter. Intraoperative anti-emetics and postoperative rescue treatments for pruritus and nausea were standardized.
Patients were interviewed q6H for scored pruritus, nausea, and pain, using standardized scales.
The trial was terminated for futility after interim analysis. Forty-six children were recruited and 45 completed data collection. No significant difference was found between both groups for incidence of pruritus (requiring treatment) [relative risk (RR) 0.9, 95% CI: 0.7, 1.2], during the first postoperative 24 h. Notably, the incidence of pruritus was 84% overall, much higher than rates in previously published studies. Intravenous ondansetron significantly reduced the incidence of nausea, compared with the placebo group [RR 0.5, 95% CI: 0.3, 0.9].
This study found no evidence for intravenous ondansetron as an effective preventative for pruritus following intrathecal morphine in children. However, this RCT did find that the rate of pruritus following intrathecal morphine administration may be significantly higher than previously thought. Nausea and vomiting (a secondary outcome) were reduced significantly in the treatment group. The negative findings of this study reinforce the potential dangers of extrapolating the drug effects seen in adults onto pediatric patients.
本研究旨在确定昂丹司琼是否可以预防儿童鞘内给予吗啡后瘙痒，如同在成人中所证明的那样。
双盲、随机安慰剂对照试验。
学术儿童医院的手术室和术后 24 小时住院病房。
46 名年龄在 3-17 岁的儿童，他们接受了 4-5mcg/kg 鞘内吗啡用于泌尿科或矫形手术。
在鞘内给予吗啡之前，儿童随机接受静脉注射昂丹司琼（治疗组）或生理盐水安慰剂（安慰剂组），之后每 6 小时给予一次，持续 24 小时。术中止吐药和术后瘙痒和恶心的解救治疗标准化。
患者每 6 小时接受瘙痒、恶心和疼痛评分的访谈，使用标准化量表。
中期分析后，该试验因无效而终止。招募了 46 名儿童，其中 45 名完成了数据收集。在术后的前 24 小时内，两组之间瘙痒（需要治疗）的发生率没有显著差异[相对风险（RR）0.9，95%置信区间：0.7，1.2]。值得注意的是，瘙痒的总体发生率为 84%，远高于先前发表的研究中的发生率。与安慰剂组相比，静脉注射昂丹司琼显著降低了恶心的发生率[RR 0.5，95%置信区间：0.3，0.9]。
本研究未发现静脉注射昂丹司琼作为儿童鞘内给予吗啡后预防瘙痒的有效方法。然而，这项 RCT 确实发现，鞘内给予吗啡后瘙痒的发生率可能明显高于先前认为的。治疗组恶心和呕吐（次要结局）的发生率显著降低。本研究的阴性结果强调了将成人中观察到的药物效应外推至儿科患者的潜在危险。
