Department of Anesthesiology, Pain and Perioperative Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
J Perinatol. 2023 Mar;43(3):271-276. doi: 10.1038/s41372-022-01487-2. Epub 2022 Aug 27.
To determine if treatment with a 5-HT3 antagonist (ondansetron) reduces need for opioid therapy in infants at risk for neonatal opioid withdrawal syndrome (NOWS).
A multicenter, randomized, placebo controlled, double blind clinical trial of ninety (90) infants. The intervention arms were intravenous ondansetron or placebo during labor followed by a daily dose of ondansetron or placebo in infants for five days.
Twenty-two (49%) ondansetron-treated and 26 (63%) placebo-treated infants required pharmacologic treatment (p > 0.05). The Finnegan score was lower in the ondansetron-treated group (4.6 vs. 5.6, p = 0.02). A non-significant trend was noted for the duration of hospitalization. There was no difference in need for phenobarbital or clonidine therapy, or total dose of morphine in the first 15 days of NOWS treatment.
Ondansetron treatment reduced the severity of NOWS symptoms; and there was an indication that it could reduce the length of stay.
Clinicaltrials.gov NCT01965704.
确定 5-HT3 拮抗剂（昂丹司琼）治疗是否能减少患有新生儿阿片类戒断综合征（NOWS）风险的婴儿对阿片类药物治疗的需求。
一项多中心、随机、安慰剂对照、双盲临床试验，共纳入 90 例婴儿。干预组在分娩时接受静脉内昂丹司琼或安慰剂治疗，然后在婴儿中每天给予昂丹司琼或安慰剂治疗 5 天。
22 例（49%）昂丹司琼治疗组和 26 例（63%）安慰剂治疗组需要药物治疗（p>0.05）。昂丹司琼治疗组的芬内根评分较低（4.6 比 5.6，p=0.02）。住院时间有缩短的趋势，但无统计学意义。在 NOWS 治疗的前 15 天内，苯巴比妥或可乐定治疗的需求或吗啡的总剂量在两组之间无差异。
昂丹司琼治疗减轻了 NOWS 症状的严重程度；并且表明它可能缩短住院时间。
Clinicaltrials.gov NCT01965704。
