Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon.
Anesth Analg. 2012 Oct;115(4):913-20. doi: 10.1213/ANE.0b013e3182652a6a. Epub 2012 Jul 13.
The frequent incidence of postoperative vomiting in children undergoing tonsillectomy, in addition to the occurrence of severe pain, may delay postoperative oral intake and lead to increased risk of dehydration. Thus, prophylactic therapy is indicated in this high-risk group. Glucocorticoids, such as dexamethasone and methylprednisolone, have anti-inflammatory and antiemetic properties with dexamethasone being frequently used. We hypothesized that methylprednisolone should be noninferior to dexamethasone for the prevention of vomiting in children after tonsillectomy.
We designed a randomized double-blind trial to compare the efficacy of a single prophylactic dose of 0.5 mg/kg dexamethasone with a dose of 2.5 mg/kg methylprednisolone on the incidence of postoperative vomiting during the first 24 hours (primary outcome) in children undergoing total or partial tonsillectomy with a noninferiority margin set at 9%. One hundred sixty children undergoing total or partial tonsillectomy under general anesthesia were randomly assigned to receive either IV dexamethasone 0.5 mg/kg (n = 79) or methylprednisolone 2.5 mg/kg (n = 81) after induction of anesthesia. Secondary analysis of all studied outcomes was also performed according to the type of surgery.
An intention-to-treat analysis showed an overall incidence of vomiting of 30% in the dexamethasone group and of 22% in the methylprednisolone group (difference: 8%, 95% confidence interval [CI]: -5% to 21%). A per protocol analysis showed an incidence of vomiting of 32% and 23%, respectively (difference: 9%, and 95% CI of the difference: -5 to 23%, P(sup) = 0.28). The time and quality of oral intake and the duration of IV hydration, as well as pain and satisfaction scores and the need for analgesics, were similar between the 2 groups. The incidence of vomiting was also similar in patients who had total versus partial tonsillectomy; however, time to first oral intake, duration of IV hydration, and the need for analgesics were less with better satisfaction scores in partial versus total tonsillectomy patients.
Methylprednisolone is at worst 5% less effective than dexamethasone by the intention-to-treat analysis, and by the per protocol analysis. Thus, it is noninferior to dexamethasone in preventing vomiting after tonsillectomy in children.
扁桃体切除术后儿童频繁发生呕吐，除了发生严重疼痛外，还可能延迟术后口服摄入，导致脱水风险增加。因此，高危人群需要进行预防性治疗。地塞米松和甲泼尼龙等糖皮质激素具有抗炎和止吐作用，地塞米松常被使用。我们假设甲泼尼龙预防扁桃体切除术后儿童呕吐的效果不应劣于地塞米松。
我们设计了一项随机双盲试验，比较单次预防剂量 0.5mg/kg 地塞米松与 2.5mg/kg 甲泼尼龙在全麻下行扁桃体全部或部分切除术儿童术后 24 小时内呕吐发生率的差异（主要结局），非劣效性边界为 9%。160 名全麻下行扁桃体全部或部分切除术的儿童在诱导麻醉后随机分为静脉注射地塞米松 0.5mg/kg（n=79）或甲泼尼龙 2.5mg/kg（n=81）。还根据手术类型对所有研究结果进行了二次分析。
意向治疗分析显示，地塞米松组总体呕吐发生率为 30%，甲泼尼龙组为 22%（差异：8%，95%置信区间[CI]：-5%至 21%）。按方案分析显示，呕吐发生率分别为 32%和 23%（差异：9%，95%CI 差值：-5%至 23%，P(sup)=0.28）。两组之间的口服摄入时间和质量、静脉补液时间以及疼痛和满意度评分以及对镇痛药的需求相似。在接受全部或部分扁桃体切除术的患者中，呕吐发生率也相似；然而，与全部扁桃体切除术患者相比，部分扁桃体切除术患者首次口服摄入时间、静脉补液时间和对镇痛药的需求更少，满意度评分更高。
按意向治疗分析，甲泼尼龙的效果比地塞米松差最多 5%，而按方案分析则相同。因此，它在预防儿童扁桃体切除术后呕吐方面与地塞米松一样有效。
