BACKGROUND Postoperative nausea and vomiting (PONV) is common after general anesthesia, with consequences for patient outcomes, satisfaction with care and healthcare costs. Our aim was to compare a new treatment, chewing gum, with a widely-used intravenous agent, ondansetron, to treat PONV in female patients in the post anesthesia care unit (PACU). METHODS We conducted a multicenter, randomized, controlled non-inferiority trial in 17 hospitals in Australia and New Zealand. Female patients aged ≥12 years undergoing volatile anesthetic-based general anesthesia for laparoscopic or breast surgery were enrolled. Protocolized anti-emetic prophylaxis was administered. Patients who developed PONV in the PACU were randomized to either 15 min of chewing gum or 4 mg of intravenous ondansetron. The primary outcome was cessation of nausea, retching or vomiting, with no recurrence nor rescue medication for 2 h after administration of the randomized intervention (i.e., complete response). RESULTS Of 865 enrolled patients, 218 were randomized. In a per-protocol analysis, 50 of 105 (47.6%) ondansetron-treated patients compared with 31 of 103 (30.1%) chewing gum-treated patients achieved the primary outcome (absolute risk difference [95% confidence interval (CI)] -17.3 [-30.4 to -4.3] %), not reaching our prespecified non-inferiority limit. Time to complete response was longer for patients randomized to chewing gum (hazard ratio [95% CI] 0.53 [0.34, 0.83]), and they were more likely to receive antiemetics in the 24 h after surgery (absolute risk difference [95% CI] 14.07 [1.65, 26.49]). CONCLUSIONS Chewing gum cannot be recommended as an alternative to ondansetron for treatment of PONV in female patients administered antiemetic prophylaxis.

中文翻译：

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嚼口香糖治疗女性患者术后恶心和呕吐：一项多中心随机试验。


背景 术后恶心呕吐 （PONV） 在全身麻醉后很常见，对患者预后、护理满意度和医疗保健费用有影响。我们的目的是比较一种新的治疗方法，口香糖，与一种广泛使用的静脉注射剂昂丹司琼，用于治疗麻醉后监护病房 （PACU） 女性患者的 PONV。方法 我们在澳大利亚和新西兰的 17 家医院进行了一项多中心、随机、对照非劣效性试验。纳入 ≥12 岁接受基于挥发性麻醉的全身麻醉进行腹腔镜或乳房手术的女性患者。进行方案化止吐预防。在 PACU 中发生 PONV 的患者被随机分配到 15 分钟口香糖组或 4 mg 静脉注射昂丹司琼组。主要结局是恶心、干呕或呕吐停止，随机干预后 2 h 内无复发或抢救药物 （即完全缓解）。结果 在 865 例入组患者中，218 例是随机分组的。在根据方案分析中，105 名昂丹司琼治疗患者中有 50 名 （47.6%） 与103 名口香糖治疗患者中的 31 名 （30.1%） 达到主要结局（绝对风险差 [95% 置信区间 （CI）] -17.3 [-30.4 至 -4.3] %），未达到我们预先设定的非劣效性限度。随机分配至口香糖组的患者完全缓解的时间更长 （风险比 [95% CI] 0.53 [0.34， 0.83]），并且他们更有可能在术后 24 小时内接受止吐药 （绝对风险差 [95% CI] 14.07 [1.65， 26.49]）。结论 不能推荐口香糖作为昂丹司琼的替代品来治疗接受止吐预防的女性患者的 PONV。