Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Change in Nausea Severity
研究概览
简要总结
This study will compare two different ways to relieve nausea and vomiting in the Emergency Department. The usual treatment for nausea/vomiting is a drug called Zofran, but new studies have suggested that smelling alcohol pads can also help to relieve nausea and vomiting.
详细描述
Emergency physicians commonly use medications to alleviate nausea and vomiting. The medication Ondansetron is used in the emergency department and after surgery for this purpose. Inhaled isopropyl alcohol has been successfully used to decrease nausea and vomiting after surgery. No trial has compared inhaled isopropyl alcohol to Ondansetron in a clinical trial.
The author proposes to prospectively investigate extension of the established antiemetic efficacy of inhaled isopropyl alcohol for undifferentiated nausea in Emergency Department patients to the 30-minute post-intervention point that has been reported to be the frequent juncture of symptom relief. By introducing prolonged intervention, and re-dosing of established benefit, into this research, the author aims to reproduce the sustained antiemetic efficacy of inhaled isopropyl alcohol for undifferentiated nausea as demonstrated for post-operative nausea and vomiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years presenting to the emergency department complaining of current nausea with or without episodes of emesis beginning within the previous 24hrs
排除标准
- •Patients with known allergy to isopropyl alcohol
- •Patients outside of the defined age range
- •Patients with an inability to inhale through the nares (including recent upper respiratory infection)
- •Patients greater than 20 weeks estimated gestation
- •Patients with past medical history of gastroparesis, or hemoptysis
- •Patients who have taken an antiemetic medication in the past 48 hours
- •Patients demonstrating hemodynamic instability with systolic blood pressure <90 or tachycardia >120 bpm
研究组 & 干预措施
Inhaled Isopropyl Alcohol (IPA)
Inhaled Isopropyl Alcohol (alcohol prep pad)
干预措施: Inhaled Isopropyl Alcohol (IPA) (Other)
Oral Dissolvable Tablet Zofran (OZ)
4 mg Oral Dissolvable Tablet Zofran (ondansetron)
干预措施: Oral Dissolvable Tablet Zofran (ondansetron) (Drug)
结局指标
主要结局
Change in Nausea Severity
时间窗: 60 minutes
Patient's nausea severity will be assessed at three time points by the study personnel using a verbal nausea rating scale over the course 60 minutes. Severity is scored 0-10 (0 = no nausea; 10 = severe nausea). Time points are at 0 minutes, 30 minutes, and 60 minutes.
次要结局
- Emesis Event(60 minutes)
研究者
Scott Crawford
Associate Professor
Texas Tech University Health Sciences Center, El Paso