Inhaled Isopropyl Alcohol for the Treatment of Nausea in a Pediatric Emergency Department: A Open Label, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in Nausea Score at 30 Minutes
研究概览
简要总结
To determine the efficacy of inhaled isopropyl alcohol in treating nausea/vomiting among pediatric patients compared with the conventional ondansetron, or placebo treatment in a tertiary care pediatric emergency department.
详细描述
I. Obtaining consent Our study personnel will approach the treating physician in the ED once a patient is suspected to be eligible for the study. The physician will determine patient's eligibility by using the screening sheet. If a patient meets all study inclusion and exclusion criteria, our study personnel will approach the legal guardian/patient in the private patient room and introduce the study to them. Enough time will be given to the patient and their legal guardian to allow them review and understand the consent/assent. All questions will be answered before obtaining the consent. Once the consent/assent is obtained from the legal guardian and participant, our study personnel will keep the treating physician and bedside nurse posted about the enrollment.
II. Randomization of subject
There will be three arms of this study:
- Conventional oral ondansetron (Zofran) treatment group,
- Inhaled isopropyl alcohol treatment group,
- Inhaled normal saline (placebo) group. After obtaining informed consent, the patients will be randomized into one of the three groups following a randomization table created by a statistician.
Whichever intervention is randomly selected will be used to treat the subject. Our research team member will notify the treating physician and the bedside RN about the assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a chief complaint of nausea or vomiting
- •Ages 7-178 years, both sexes
- •Weight ≥ 15 kg
- •Baxter Animated Retching Faces (BARF) nausea severity score ≥ 4/10
排除标准
- •1. Require IV access
- •Inability to breathe in/out through the nose
- •Anosmia (self- or parental report)
- •Allergy to isopropyl alcohol or ondansetron
- •Current or history of alcohol abuse
- •Inability to communicate feeling nauseous
- •Inability to follow directions regarding taking deep breaths through the nose
- •Known prolonged QT interval
- •Pregnancy
- •Received antiemetics within the last 8 hours
- •Currently taking apomorphine
研究组 & 干预措施
Inhaled Isopropyl Alcohol
If the subject is assigned to receive the isopropyl alcohol pad group, an isopropyl alcohol pad (Covidien Webcol 2 ply prep pad, saturated with 70% isopropyl alcohol) will be given to the subject, or the legal guardian. The alcohol pad will be held 1-2 cm under the subject's nares, the subject will be instructed to take deep breaths, inhaling through the nose as frequently as needed during the Emergency Department (ED) stay.
干预措施: Inhaled Isopropyl Alcohol (Other)
Oral Ondansetron
If the subject is assigned to receive ondansetron treatment, subject will be provided with 4 mg ondansetron oral disintegrating tablet (ODT) for treatment.
干预措施: Oral Ondansetron (Drug)
Inhaled Placebo
If the subject is assigned to receive the inhaled placebo, a normal saline pad (Hygea sterile saline wipe) will be given to the subject or the legal guardian. The saline wipe will be held under the subject's nares, the subject will be instructed to take deep breaths, inhaling through the nose as frequently as needed.
干预措施: Inhaled Placebo (Other)
结局指标
主要结局
Change in Nausea Score at 30 Minutes
时间窗: 30 minutes post-intervention as compared to baseline
Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea
Change in Nausea Score at 10 Minutes
时间窗: 10 minutes post-interventnon as compared to baseline
Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea
Change in Nausea Score at Discharge
时间窗: At ED discharge (assessed up to 10 hours) as compared to baseline
Baxter Animated Retching Faces nausea score, 0-10 with higher score meaning worse nausea
次要结局
- Vomiting(From intervention to time of ED discharge (assessed up to 10 hours))
- Parent/Caregiver Satisfaction(At time of ED discharge (assessed up to 10 hours))
- Nurse Satisfaction in Ease of Administering the Treatment(At time of ED discharge (assessed up to 10 hours))
- Length of Stay(From arrival to time of ED discharge (assessed up to 10 hours))
研究者
Susana Ruano
Pediatric Emergency Medicine Fellow
State University of New York at Buffalo