Sections of Pediatric Emergency Medicine and Gastroenterology, Departments of Pediatrics and Emergency Medicine, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Alberta Children's Hospital, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Trials. 2020 May 27;21(1):435. doi: 10.1186/s13063-020-04347-6.
There are limited treatment options that clinicians can provide to children presenting to emergency departments with vomiting secondary to acute gastroenteritis. Based on evidence of effectiveness and safety, clinicians now routinely administer ondansetron in the emergency department to promote oral rehydration therapy success. However, clinicians are also increasingly providing multiple doses of ondansetron for home use, creating unquantified cost and health system resource use implications without any evidence to support this expanding practice.
METHODS/DESIGN: DOSE-AGE is a randomized, placebo-controlled, double-blinded, six-center, pragmatic clinical trial being conducted in six Canadian pediatric emergency departments (EDs). In September 2019 the study began recruiting children aged 6 months to 18 years with a minimum of three episodes of vomiting in the 24 h preceding enrollment, <72 h of gastroenteritis symptoms and who were administered a dose of ondansetron during their ED visit. We are recruiting 1030 children (1:1 allocation via an internet-based, third-party, randomization service) to receive a 48-h supply (i.e., six doses) of ondansetron oral solution or placebo, administered on an as-needed basis. All participants, caregivers and outcome assessors will be blinded to group assignment. Outcome data will be collected by surveys administered to caregivers 24, 48 and 168 h following enrollment. The primary outcome is the development of moderate-to-severe gastroenteritis in the 7 days following the ED visit as measured by a validated clinical score (the Modified Vesikari Scale). Secondary outcomes include duration and frequency of vomiting and diarrhea, proportions of children experiencing unscheduled health care visits and intravenous rehydration, caregiver satisfaction with treatment and safety. A preplanned economic evaluation will be conducted alongside the trial.
Definitive data are lacking to guide the clinical use of post-ED visit multidose ondansetron in children with acute gastroenteritis. Usage is increasing, despite the absence of supportive evidence. The incumbent additional costs associated with use, and potential side effects such as diarrhea and repeat visits, create an urgent need to evaluate the effect and safety of multiple doses of ondansetron in children focusing on post-emergency department visit and patient-centered outcomes.
ClinicalTrials.gov: NCT03851835. Registered on 22 February 2019.
对于因急性肠胃炎而出现呕吐症状、前来急诊就诊的儿童，临床医生可提供的治疗方案有限。基于有效性和安全性证据，临床医生现在通常在急诊室给予昂丹司琼以促进口服补液疗法的成功。然而，临床医生也越来越多地为家庭使用提供多次剂量的昂丹司琼，在没有任何证据支持这种扩大治疗方案的情况下，造成了无法量化的成本和卫生系统资源利用。
方法/设计：DOSE-AGE 是一项在加拿大六个儿科急诊中心进行的随机、安慰剂对照、双盲、六中心、实用临床试验。2019 年 9 月，该研究开始招募年龄在 6 个月至 18 岁之间的儿童，这些儿童在入组前 24 小时内至少呕吐 3 次，肠胃炎症状持续时间＜72 小时，并且在急诊就诊时接受了昂丹司琼治疗。我们正在招募 1030 名儿童（通过互联网第三方随机服务进行 1:1 分配），为他们提供 48 小时的昂丹司琼口服溶液或安慰剂供应（即 6 剂），按需服用。所有参与者、照护者和结局评估者将对分组情况不知情。将通过在入组后 24、48 和 168 小时向照护者进行问卷调查收集结局数据。主要结局是 ED 就诊后 7 天内发展为中重度肠胃炎，这通过经过验证的临床评分（改良 Vesikari 量表）进行测量。次要结局包括呕吐和腹泻的持续时间和频率、需要非计划性就诊和静脉补液的儿童比例、照护者对治疗的满意度以及安全性。计划进行预先设定的经济学评价。
缺乏明确的数据来指导临床医生在患有急性肠胃炎的儿童中使用 ED 后多剂量昂丹司琼。尽管缺乏支持性证据，但该药物的使用仍在增加。由此产生的额外成本以及腹泻和重复就诊等潜在副作用，迫切需要评估多剂量昂丹司琼在关注 ED 后就诊和以患者为中心的结局的儿童中的效果和安全性。
ClinicalTrials.gov：NCT03851835。注册于 2019 年 2 月 22 日。
