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临床试验/NCT02618343
NCT02618343已完成不适用

A Randomized Control Equivalence Study of Emergency Medical Services Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron for Treatment of Pre-hospital Nausea

The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2016年10月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Time to Nausea Reduction by 50% by Visual Analog Scale.

研究概览

简要总结

Nausea is a common symptom encountered in the Emergency Medical Services (EMS) environment that is often treated with oral or intravenous anti-emetic medications. Research Design/Plan: This will be a randomized equivalence study comparing the reduction in a patient's reported level of nausea after treatment with either Ondansetron or IPA Methods: Patients who report nausea and/or vomiting in the normal evaluation and care of after calling 911 for Emergency Medical Care will be offered enrollment in the study. A short script will be attached to the outside of each study packet providing information about the study and its risks and benefits. Verbal or written (waiver of informed consent will be requested) permission will be obtained to start randomization. If the patient agrees to enroll then the study packet will be opened and utilized. All Advanced Life Support Ambulances in the San Antonio Fire Department will have sealed numbered opaque boxes or envelopes with either: 70% Isopropyl Alcohol swabs or ondansetron. Six Visual Nausea Severity Scoring cards will be provided with a marking pen to record timed nausea levels before and upon arrival to the Emergency Department and 15 minutes after treatment whichever comes first.

Clinical Relevance: This treatment has not been studied in the unique environment encountered by Paramedics in the Pre-Hospital setting. If this treatment is found to be effective, it many offer a very simple, extremely inexpensive and non-invasive (basic life support) approach for the treatment of nausea.

详细描述

Nausea is a common symptom encountered in the Emergency Medical Services (EMS) environment that is often treated with oral or intravenous anti-emetic medications. Post operative patients with modern anesthesia techniques and processes still have a 20-30% incidence of Nausea and/or vomiting. Nausea is a complicated symptom that is though to arise from the vomiting center in the lateral reticular formation in the brainstem. Afferent inputs form the cerebellum, higher cortical centers, the vestibular apparatus, the glossopharyngeal nerve and the vagal nerve inputs contribute to the process of the perception of nausea. Chemoreceptors in the Chemoreceptor Trigger Zone (CTZ) are located on the brain surface and are highly vascularized leading to increased exposure to neurotransmitters such as Serotonin (5-HT-3), histamine (H1) acetylcholine and dopamine. Blocking such neurotransmitter stimulation with targeted medications such as antihistamines or 5-HT-3 antagonists such as Ondansetron.

Nausea is a common symptom encountered in the Emergency Medical Services (EMS) environment that is often treated with oral or intravenous anti-emetic medications. Many patients do not respond well to this therapy, and EMS services that have only basic life support (BLS) capabilities may not have any good treatment currently. Additionally, because of the configuration of modern day ambulances, the patient is transport in a rear facing position in the patient compartment with very limited view of the environment. This method of transport frequently causes motion sickness.

Motion sickness is thought to be caused by inadequate adaption of the body to conflicts between vestibular, visual, other proprioceptive inputs and inhibition of the vestibular cerebellum. Common therapies may include antihistamines, benzodiazepines, tricyclic antidepressants and or scopolamine. Behavioral strategies such a watching the true horizon, steering the vehicle, tilting head into turns and laying down with eyes closed have been shown to alleviate some symptoms of motion sickness. But these strategies are not available in the EMS environment. Scopolamine administered well before motion stimulus has been shown to prevent motion sickness and acute treatment is best when using sedating antihistamines. Non-sedating antihistamines, Ondansetron and ginger root have not been found to effectively prevent nor treat motion sickness.

Multiple agents have been studied for the treatment of nausea in the emergency department with equivalency of effect and time on onset. Common agents include ondansetron, metoclopramide, promethazine and prochlorperazine. Such agents have also been used in the EMS environment to some degree, but require parenteral administration with exposure to the risks for side effects or sedation. There are also not options at the BLS level. Post-operative oxygen therapy has not been shown to decrease post nausea after c-section delivery which is disappointing as this is a ubiquitous therapy in the EMS environment of care, is inexpensive and easy to administer. Ondansetron has been shown to be safe and effective in the prehospital environment with a low incidence of side effects but cost and need for parenteral administration is often a barrier to care.

Multiple studies have shown Isopropyl Alcohol (IPA) 70% aromatherapy to be as effective as Ondansetron with a more rapid onset of nausea relief. This therapy was performed by holding a folded saturated 70% IPA pad under the nares with the patient inhaling the vapors. The patient is simply instructed to take three deep breaths through their nose. In animal experiments, toxicity from inhalation of IPA is very low at doses allowable by inhalation as compared with dermal or oral ingestion. Dermal application of IPA is routinely used by EMS personnel to cleanse the area of skin immediately surrounding the insertion point of an intravascular catheter for medication administration, or blood draw.

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
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (non-pregnant) age 18 years or older with a symptom of nausea and/or vomiting requiring treatment by EMS

排除标准

  • Children not yet 18 years of Age
  • Prisoners or those under arrest
  • Patients known or suspected to be Pregnant
  • Clinical Intoxication
  • Patients unable to provide informed consent
  • Recent Upper respiratory Tract infection
  • Inability to follow instructions
  • Inability to inhale through Nares

研究组 & 干预措施

ISOPROPYL ALCOHOL AROMATHERAPY

Experimental

Prehospital patients complaining of nausea randomized into the IPA Arm.

干预措施: IPA (Drug)

Ondansetron

Active Comparator

Prehospital patients complaining of nausea randomized into the ondansetron arm.

干预措施: Ondansetron (Drug)

结局指标

主要结局

Time to Nausea Reduction by 50% by Visual Analog Scale.

时间窗: Baseline and up to 10 minutes

A visual analog scale (VAS) will be utilized to determine level of nausea. The VAS scale will be utilized before enrollment, at the time of medication administration, then every 2 minutes after administration for 10 minutes. The scale is a numbered linear scale from 0-10, with 0 = no nausea and 10 = worst nausea possible

次要结局

  • Number of Subjects That Required Rescue Ondansetron(15 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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