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临床试验/NCT02985840
NCT02985840终止4 期

Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department

OhioHealth1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2014年1月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
OhioHealth
入组人数
127
试验地点
1
主要终点
Number of Participants With Need for Additional Nausea Medications

研究概览

简要总结

Nausea is a common complaint in patients who present to the emergency department (ED). Although the number of conditions that can present with nausea are numerous, the mainstay of treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but also its availability. One of the major drawbacks to using this form is that it often needs to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV ondansetron given with IV dexamethasone (Decadron) as another viable option when treating patients with nausea in the emergency department.

Previous studies in patients undergoing surgical procedures have shown that when IV dexamethasone is given with IV ondansetron to post-operative patients they have less nausea and vomiting than ondansetron alone, and were even found to show decreased post-operative pain associated with nausea. It has also been shown to decrease the need to re-dose antiemetic medication. Although this combination has not been tested in the emergency department it is believed by these investigators that the additional use of dexamethasone may decrease the need to use repeated doses of ondansetron.

The investigators believe this may change the way physicians currently approach the nauseated patient in regards to treatment. That rather than possibly giving multiple doses of one medication over and over to reduce a patient's nausea, physicians can give two medications together at one time. The investigators hope to demonstrate that by giving intravenous dexamethasone and ondansetron together, it may be possible to reduce the number of patients who need additional doses of nausea medication.

详细描述

Nausea is a common complaint in patients who present to the emergency department (ED). Although the number of conditions that can present with nausea are numerous, the mainstay of treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but also its availability. One of the major drawbacks to using this form is that it often needs to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV ondansetron given with IV dexamethasone (Decadron) as another viable option when treating patients with nausea in the emergency department.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chief Complaint of nausea or abdominal pain with nausea
  • Inability to tolerate oral nausea medication
  • Patients with a negative pregnancy test

排除标准

  • Patients younger than 18 years of age
  • Patient's chief complaint includes headache, chest pain, or dizziness
  • Patients with whom there are contraindications to using the studied medicine (allergies, known adrenal disease)
  • Blood sugar greater than 300
  • Non-English speaking subjects

研究组 & 干预措施

Ondansetron

Active Comparator

Ondansetron (4 mg) followed by two 5 ml normal saline flush

干预措施: Ondansetron (Drug)

Ondansetron plus dexamethasone

Experimental

Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush

干预措施: Ondansetron (Drug)

Ondansetron plus dexamethasone

Experimental

Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Number of Participants With Need for Additional Nausea Medications

时间窗: 1 hour post intervention

Effectiveness of intervention will be assessed by the need for additional medications via chart review

次要结局

  • Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms(1 hour post intervention)

研究者

发起方
OhioHealth
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Little

Attending Physician

OhioHealth

研究点 (1)

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