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临床试验/NCT05065567
NCT05065567终止3 期

A Comparison of Haloperidol 5mg IM vs Droperidol 2.5mg and Ondansetron for the Treatment of Hyperemesis in Cannabis Hyperemesis Syndrome

Spectrum Health - Lakeland1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年8月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
发起方
入组人数
32
试验地点
1
主要终点
Abdominal Pain

研究概览

简要总结

The purpose of this study is to compare two commonly used agents for the treatment of cyclic vomiting to see if one agent is inferior to the other in time to improvement in symptoms, need for repeat or rescue medications, treatment failures and complications/side effects.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients with clinical diagnosis of cyclic vomiting in the ED

排除标准

  • pregnancy, allergy to any of the study medicines

研究组 & 干预措施

haloperidol

Active Comparator

these patients will receive 5mg IM haloperidol

干预措施: Haloperidol (Drug)

droperidol

Active Comparator

these patients will receive 2.5mg IV droperidol

干预措施: Droperidol (Drug)

ondansetron

Active Comparator

these patients will receive 8mg IV ondansetron

干预措施: Ondansetron 8mg (Drug)

结局指标

主要结局

Abdominal Pain

时间窗: 48 hours

change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale

Nausea

时间窗: 48 hours

change in nausea on 0 (none) through 10 (worse possible nausea) on a scale

次要结局

  • Treatment Success(48 hours)

研究者

发起方
Spectrum Health - Lakeland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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