Roslund Gregory, Hepps Terri S, McQuillen Kemedy K
Department of Emergency Medicine, St. Joseph Regional Medical Center, South Bend, IN, USA.
Ann Emerg Med. 2008 Jul;52(1):22-29.e6. doi: 10.1016/j.annemergmed.2007.09.010. Epub 2007 Nov 19.
We hypothesize that ondansetron will facilitate oral rehydration therapy in children with acute gastritis or acute gastroenteritis and mild to moderate dehydration who fail initial oral rehydration therapy. We hypothesize that subjects receiving ondansetron will tolerate oral rehydration and that a lower proportion will require intravenous hydration than subjects receiving placebo, with a clinically important difference of at least 30% when comparing 2 groups of patients presenting to the ED with acute gastritis/acute gastroenteritis. Secondarily, we hypothesize that subjects receiving ondansetron will have a lower proportion requiring admission, fewer episodes of vomiting and diarrhea, and fewer revisits.
This double-blind, placebo-controlled, prospective, randomized trial enrolled a convenience sample of subjects 1 to 10 years old, with acute gastritis or acute gastroenteritis, who failed oral rehydration therapy in the emergency department (ED). Subjects received a weight-based dose of ondansetron (0.15 mg/kg of the orally dissolving tablet) or placebo, and oral rehydration therapy was reattempted 30 minutes later. If a subject vomited or refused to drink, he or she was considered a failed oral rehydration therapy and received IV hydration [corrected] If a subject tolerated adequate oral rehydration therapy, he or she was discharged. Parents completed symptom diaries and were contacted by telephone for follow-up. We used the chi(2) test to compare the proportions of subjects requiring IV hydration [corrected] in each group.
We enrolled 106 subjects: 51 received ondansetron and 55 received placebo. Eleven of 51 (21.6%; 95% confidence interval [CI] 11.3% to 35.3%) of subjects who received ondansetron required intravenous hydration and 30 of 55 (54.5%; 95% CI 40.6% to 68%) of placebo subjects required intravenous hydration (p <0.001) for a difference of 32.9% (95% CI 14.54% to 48.37%). Admission rates were 5.9% (3/51) with ondansetron and 12.7% (7/55) with placebo.
In subjects with acute gastritis/acute gastroenteritis and mild to moderate dehydration who failed initial oral rehydration therapy, the proportion of children who received intravenous hydration was smaller in the ondansetron group than in the placebo group.
我们假设昂丹司琼将有助于急性胃炎或急性胃肠炎伴轻度至中度脱水且初始口服补液治疗失败的儿童进行口服补液治疗。我们假设接受昂丹司琼治疗的受试者能够耐受口服补液，且与接受安慰剂的受试者相比，需要静脉补液的比例更低，在比较两组因急性胃炎/急性胃肠炎就诊于急诊科的患者时，临床重要差异至少为30%。其次，我们假设接受昂丹司琼治疗的受试者需要住院的比例更低、呕吐和腹泻发作次数更少以及复诊次数更少。
这项双盲、安慰剂对照、前瞻性随机试验纳入了1至10岁因急性胃炎或急性胃肠炎在急诊科口服补液治疗失败的受试者便利样本。受试者接受基于体重剂量的昂丹司琼（0.15mg/kg口服分散片）或安慰剂，30分钟后再次尝试口服补液治疗。如果受试者呕吐或拒绝饮水，则视为口服补液治疗失败并接受静脉补液[校正后]。如果受试者耐受充分的口服补液治疗，则予以出院。家长完成症状日记，并通过电话进行随访。我们使用卡方检验比较每组中需要静脉补液[校正后]的受试者比例。
我们纳入了106名受试者：51名接受昂丹司琼治疗，55名接受安慰剂治疗。接受昂丹司琼治疗的51名受试者中有11名（21.6%；95%置信区间[CI]11.3%至35.3%）需要静脉补液，而接受安慰剂治疗的55名受试者中有30名（54.5%；95%CI40.6%至68%）需要静脉补液（p<0.001），差异为32.9%（95%CI14.54%至48.37%）。昂丹司琼组的住院率为5.9%（3/51），安慰剂组为12.7%（7/55）。
在急性胃炎/急性胃肠炎伴轻度至中度脱水且初始口服补液治疗失败的受试者中，昂丹司琼组接受静脉补液的儿童比例低于安慰剂组。
