Inhaled Isopropyl Alcohol Versus Placebo to Manage Nausea at Electronic Dance Music Festivals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 9
- 主要终点
- Self-reported nausea scores
研究概览
简要总结
BACKGROUND
Studies have shown that isopropyl alcohol inhalation is effective for the relief of nausea in the emergency department. A 2016 randomized controlled trial found that nasally inhaled isopropyl alcohol achieved better nausea relief compared to placebo during a 10-minute period. In 2018, another randomized controlled trial showed that nasally inhaled isopropyl alcohol with or without oral ondansetron provided greater relief for nausea than oral ondansetron alone.
QUESTION
In electronic dance music festival attendees, who present with nausea to the medical team, how does inhaled isopropyl alcohol compare with inhaled sterile saline (placebo) for self-reported nausea 10-minutes post-intervention?
METHODS
Canadian electronic dance music festival attendees who present with nausea to the medical team, will be recruited until sample size reaches at least 70. Inclusion criteria will be festival attendees aged 18+ with a complaint of nausea. Exclusion criteria will include known allergy to isopropyl alcohol, inability to inhale through the nares, inability to report level of nausea, or already have taken an anti-nauseant.
After obtaining consent, participants will be randomized into two study arms. Arm 1 will nasally inhale an isopropyl alcohol pad with 10 deep inhalations (intervention). Arm 2 will nasally inhale a sterile saline pad with 10 deep inhalations (placebo). The pad must be within 2cm from the nares to ensure delivery. According to a study in 2002, isopropyl alcohol pad inhalation, dosed at 3 inhalations every 5 minutes for 3 doses, was not significantly different than standard treatment for relief of nausea. 10 inhalations exceeds the 9-dose total reported in the paper, and a one-time bolus dose of 10 inhalations, for the population and festival context, is more feasible in terms of patient compliance and patient flow.
After randomization, participants will rate their nausea on a numeric response scale (0 to 10, where 0 is no nausea and 10 is "worst nausea imaginable"). 10-minutes post-inhalation (isopropyl alcohol or placebo), participants will be asked to rate their nausea again.
The primary outcome is self-reported nausea scores 10-minutes post-intervention. The secondary outcome is the presence or absence of any vomiting spells 10-minutes post-intervention, as well as the presence or absence of rescue-medication needed 10-minutes post-intervention.
详细描述
POPULATION OF INTEREST
Participants will be recruited from electronic dance music (EDM) festivals in Canada. This population was chosen because festival participants often present to event medical staff with a complaint of nausea, in a setting where the availability of medical resources such as oral and intravenous anti-nauseants are more limited than an emergency department. Although the effectiveness of isopropyl alcohol pads as anti-nauseant therapy has been demonstrated in hospital emergency rooms, no prior studies, to the investigators' knowledge, have assessed outcomes in festival populations. This study will be conducted by adapting protocols from prior studies that examined the effects of inhaled isopropyl alcohol on patient-reported nausea and will add to the current state of knowledge by investigating a novel population.
EDM events are included in this study, because the investigators have long-standing experience working at these festivals as part of the main medical team, responsible for providing medical care to all festival participants. Odyssey Medical, the organization that oversees all medical staff at these EDM events, has granted the investigators permission to integrate the proposed research study into patient care at these festivals. This organization recruits multi-disciplinary volunteers (physicians, nurses, respiratory therapists, pharmacists, lifeguards, paramedics, and first aiders) to manage the medical needs of festival attendees.
PARTICIPANT SCREENING
Participants will verbally respond to screening questions, with responses recorded electronically by Research Personnel #1 (aka "the assessor") on a secure Google Form (printed copies will be available as back-up). Individuals who satisfy all inclusion/exclusion criteria will continue in the study, while those who do not meet criteria will receive standard medical care as needed (e.g. oral or intravenous anti-nauseant).
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
- Double (Participant, Outcomes Assessor)
盲法说明
An intervention/care provider will remove the packaging so that participants will be unable to identify the inhaled substance. We acknowledge that the smell of isopropyl alcohol may be familiar and thus identifiable for some treatment arm participants. However, participants will not be informed of the identity of the treatment and placebo during the consent process, instead only being told that we are comparing two inhaled substances to assess their relative effectiveness. Thus, recognizing they are inhaling isopropyl alcohol should not bias participants' responses, given they will not know whether isopropyl alcohol is a treatment or control.
The outcomes assessor will be blinded, because the randomization and intervention delivery are both completed by the intervention/care provider, who will not be involved in screening/baseline assessment nor outcome assessments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Festival attendees aged 18+
- •A complaint of nausea of at least 1 on a scale of 0 to 10 (11-point scale, where 0 represents "no nausea" and 10 represents "worst nausea imaginable").
排除标准
- •Known allergy to isopropyl alcohol (standard practice involves medical team members asking patients what allergies they have; we will not directly ask about isopropyl alcohol in order to keep participants blinded to interventions)
- •Inability to inhale through the nares (e.g. distorted nasal anatomy, active nosebleed, obstructed nasal passages, rhinitis, anosmia)
- •Inability to verbally report level of nausea
- •Prior administration of an oral or intravenous anti-nauseant (e.g. metoclopramide, ondansetron, dimenhydrinate) by festival medical staff since arrival at the festival (would confound treatment effect)
研究组 & 干预措施
Isopropyl Alcohol
10 inhalations of an isopropyl alcohol pad held within 2cm from the nares
干预措施: Isopropyl alcohol (Drug)
Sterile Saline
10 inhalations of a sterile saline pad held within 2cm from the nares
干预措施: Placebo (Other)
结局指标
主要结局
Self-reported nausea scores
时间窗: 10-minutes post-intervention
Nausea rated on an 11-point scale (0 = "no nausea", 10 = "worst nausea imaginable")
次要结局
- Presence of vomiting(10-minutes post-intervention)
- Use of rescue-medication (i.e. oral/intravenous anti-nauseant)(10-minutes post-intervention)
研究者
Anthony Seto
Course Chair, "Intro to Clinical Practice"
University of Calgary