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昂丹司琼口腔崩解片:在接受腺扁桃体切除术儿童中的可接受性和疗效

Ondansetron oral disintegrating tablets: acceptability and efficacy in children undergoing adenotonsillectomy.

作者信息

Cohen Ira Todd, Joffe Denise, Hummer Kelly, Soluri Alice

机构信息

Department of Anesthesiology, Children's National Medical Center, 111 Michigan Ave. NW, Washington, DC 20010, USA.

出版信息

Anesth Analg. 2005 Jul;101(1):59-63, table of contents. doi: 10.1213/01.ANE.0000154186.03161.35.

DOI:10.1213/01.ANE.0000154186.03161.35
PMID:15976206
Abstract

Postoperative nausea and vomiting (PONV), a major complication in children, is responsive to IV and oral ondansetron. Because these routes are not always available, we studied the acceptability and efficacy of ondansetron oral disintegrating tablets (ODT). In this double-blind, randomized, placebo-controlled study, 62 patients undergoing adenotonsillectomy, aged 5 to 11 years, preoperatively received ODT (4 mg) or placebo. Patients assessed the medication for taste and sensation. Anesthesia was induced with sevoflurane, maintained with desflurane, and supplemented with fentanyl 2.5 microg/kg and dexamethasone 0.5 mg/kg (maximum dose, 12 mg). An observer blinded to treatment evaluated patients for pain, agitation, and PONV. Postoperative treatment consisted of fentanyl 1 microg/kg for pain and agitation and metoclopramide 0.15 mg/kg (maximum dose, 10 mg) for PONV. There were no significant differences between study groups with regard to age, weight, recovery time, agitation, or pain. Approximately 90% of the subjects found the ODT to taste good. No subject rejected the study medication, but the ondansetron-containing tablets were found to be less palatable than the placebo. The incidence of vomiting was significantly less in the ondansetron-medicated group.

摘要

术后恶心呕吐(PONV)是儿童的一种主要并发症,对静脉注射和口服昂丹司琼有反应。由于这些给药途径并非总是可行,我们研究了昂丹司琼口腔崩解片(ODT)的可接受性和疗效。在这项双盲、随机、安慰剂对照研究中,62例年龄在5至11岁接受腺扁桃体切除术的患者术前接受了ODT(4毫克)或安慰剂。患者对药物的味道和感觉进行评估。麻醉诱导采用七氟醚,维持采用地氟醚,并补充2.5微克/千克芬太尼和0.5毫克/千克地塞米松(最大剂量12毫克)。一名对治疗不知情的观察者对患者的疼痛、躁动和PONV进行评估。术后治疗包括用于疼痛和躁动的1微克/千克芬太尼以及用于PONV的0.15毫克/千克甲氧氯普胺(最大剂量10毫克)。研究组在年龄、体重、恢复时间、躁动或疼痛方面没有显著差异。约90%的受试者觉得ODT味道不错。没有受试者拒绝研究药物,但发现含昂丹司琼的片剂不如安慰剂可口。昂丹司琼用药组的呕吐发生率显著较低。

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