ACTRN12619001205123已完成4 期
Therapeutic Management of Nausea in the Emergency Department: A randomised comparison of Droperidol and Ondansetron
A/Prof Gabriel T Lau0 个研究点目标入组 180 人开始时间: 2019年8月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Emergency Department patients aged 18 years or more, with nausea and/or vomiting as a primary or secondary complaint (any underlying cause).
排除标准
- •* Known allergy to ondansetron or droperidol
- •* Use of an agent with known antiemetic properties in the previous 4 hours, either prior to ED arrival, or earlier in the current ED episode of care. Includes: ondansetron, droperidol, metoclopramide, promethazine, chlorpromazine, prochlorperazine and any steroid medication.
- •* Patients considered too unwell to consent or participate for any reason, including cardiovascular instability, hepatic failure, renal failure or altered mental state.
- •* Contraindication to the administration of normal saline infusion during the study period (e.g. left ventricular failure, chronic renal failure)
- •* Patients with Parkinson’s disease or restless leg syndrome.
- •* Patients taking a dopamine antagonist for any reason. Includes: amisulpride, chlorpromazine, clopenthixol or flupenthixol, domperidone, haloperidol, paliperidone, quetiapine, risperidone, thioridazine.
- •* Patients with cognitive impairment or language barrier which compromises understanding of the outcome measurements.
- •* Patients with motion related nausea or vertigo, which have other specific recommended treatments, albeit with little supporting evidence
- •* Pregnant or breast feeding women; ondansetron is category B and droperidol category C, with both being excreted to breast milk
- •* Chemotherapy or radiotherapy induced nausea and vomiting (CINV or RINV), which have other specific recommended antiemetic treatments
- •* Inability to comply with an instruction to not drive or operate machinery for a minimum of 4 hours post-dosage; droperidol may impair these functions for a period of time, although 1.25 mg IV is a relatively small dose compared with dosages used for other indications
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