Isopropyl Alcohol Inhalation as Anti-emetic Therapy in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in nausea scores from pre-intervention to post-intervention
研究概览
简要总结
Nausea and vomiting is a common and distressing presenting complaint in Canadian emergency departments. Commonly used nausea medications have proven to be effective in certain patient populations, for example cancer patients. However, not one has been proven to be more effective that the other in the emergency department setting. In addition, many are associated with significant side effects and have the potential to interact with a patient's home medications. This limits their use in the emergency department until the patient is seen and assessed by their treating physician.
Many studies have shown that nasal inhalation of alcohol swabs is an effective therapy in relieving nausea and vomiting in post-operative patients after surgeries. The goal of this study will be to determine the effectiveness of alcohol swabs in the emergency department setting in relieving nausea and vomiting.
详细描述
BACKGROUND INFORMATION:
Emerging evidence exists supporting the use of nasally inhaled isopropyl alcohol swabs as anti-emetic therapy. Multiple studies report isopropyl alcohol inhalation as an effective treatment for post-operative nausea and vomiting, with no reported adverse events. This relatively inexpensive substance is widely available in most health care settings in the form of swabs used in the routine course of delivering care as an antiseptic skin cleanser. Two previous studies in the United States have evaluated the use of inhaled isopropyl alcohol swabs in alleviating nausea and vomiting in the emergency department setting. One study in 2016 study by Beadle et. al. demonstrated superior nausea relief using inhaled isopropyl alcohol swabs compared to an inhaled placebo, while a 2018 study by April et. al. demonstrated superior nausea relief with isopropyl alcohol swabs compared with inhaled placebo and oral ondansetron.
The 2016 study by Beadle et. al. has several important limitations. This was a single center military hospital study, which only measured nausea scores 10 minutes after isopropyl alcohol swab inhalation, and lacked other important outcomes such as the number of vomiting episodes, use of rescue anti-emetics, ED length of stay and admission rates. The 2018 study by April et. al. also has limitations. Mainly, alcohol swabs were used as often as required by participants, and the dosing frequency of inhalations was not measured. They also excluded patients who had a peripheral intravenous catheter inserted on arrival, which could suggest that patients with more severe symptoms of nausea and vomiting requiring intravenous anti-emetics were excluded.
STUDY RATIONALE:
The investigator's goal is to add to the current body of evidence on the use of isopropyl alcohol in alleviating nausea and vomiting in the emergency department, particularly by determining which dosing frequency of isopropyl alcohol inhalation yields the most effective nausea relief by randomizing patients to different inhalation frequencies. This may help to guide future triage protocols enabling isopropyl alcohol inhalation before provider evaluation to improve treatment of nausea and patient satisfaction. In the current state of emergency department overcrowding, the ability to adequately control a patient's symptoms at triage may help decrease a patient's length of stay, as well as the number of patients requiring beds. In addition, from a cost-savings perspective, alcohol swabs are a relatively inexpensive therapy as compared to many commonly administered anti-emetics.
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
盲法说明
The trial design is open label, given that blinding the scent of alcohol swabs is difficult. As such, no blinding of the study participants nor the research team to interventions will occur, as there will be no placebo intervention given.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥18 years) presenting to the emergency department with a chief complaint of nausea and/or vomiting with a level of 3 or greater on a verbal numeric response scale (1-10).
排除标准
- •Not able to breathe through nares (ie. rhinitis)
- •Known pregnancy
- •Have already received an anti-emetic within the past 24 hours (including while in emergency department triage)
- •Chronic nausea (> 1 month)
- •Known allergy to isopropyl alcohol
- •Nasally sensitive to inhaled chemical products
- •Altered mental status or underlying cognitive impairment
研究组 & 干预措施
Isopropyl alcohol swab every 10 minutes
One deep inhalation of an isopropyl alcohol swab held 1-2cm below the nares. Intervals of administration will be every 10 minutes for a total of one hour.
干预措施: Isopropyl alcohol swab (Other)
Isopropyl alcohol swab every 20 minutes
One deep inhalation of an isopropyl alcohol swab held 1-2cm below the nares. Intervals of administration will be every 20 minutes for a total of one hour.
干预措施: Isopropyl alcohol swab (Other)
No treatment arm
No intervention administered.
结局指标
主要结局
Change in nausea scores from pre-intervention to post-intervention
时间窗: From the time of randomization over two hours
Self-reported 10-point verbal numeric scale ranging from 1-10, labeled "no nausea" at the left end (1) and "worse nausea imaginable" at right end (10).
次要结局
- Subject satisfaction score(From the time of randomization over two hours)
- Receipt of rescue anti-emetics(From the time of randomization until the time of documented emergency department disposition (either admission to hospital or discharge home)
- Emergency department length of stay(From the time of emergency department arrival until documented emergency department disposition (either admission to hospital or discharge home))
- Subject disposition(From the time of emergency department arrival until documented emergency department disposition (either admission to hospital or discharge home)