A Single Center, Randomized Controlled Prospective Double-blinded Trial Comparing Haloperidol to Standard Ondansetron Therapy for Control of Nausea and Vomiting in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of nausea or vomiting. A total of 300 patients age 18-55 presenting to the emergency department with chief complaint of nausea or vomiting will be enrolled from February 2021 - February 2022. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.
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)
盲法说明
Treatment allocations will be revealed only after study completion, unless there is concern for a serious adverse event in which case treatment team and patient will be unblinded. Interim analysis will be performed at 150 participants to evaluate for effectiveness and power
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presenting to the emergency department with chief complaint of nausea or vomiting
排除标准
- •abnormal blood pressure (>200/100mmHg or <90/40mmHg),
- •fever (>100.4F),
- •acute trauma,
- •QT > 450ms on cardiac monitor,
- •altered mental status (GCS < 15),
- •chest pain,
- •known allergy to haloperidol or ondansetron,
- •Parkinson's disease,
- •pregnancy or lactation,
- •use of any antiemetic in the previous 8 hours,
- •nausea and vomiting associated with vertigo,
- •prisoners or any wards of the state.
研究组 & 干预措施
Haloperidol
2.5 mg of IV haloperidol diluted to a final concentration of 5 mL with 0.9% sodium chloride
干预措施: Haloperidol (Drug)
Ondansetron
4 mg of IV ondansetron diluted to a final concentration of 5 mL with 0.9% sodium chloride
干预措施: Ondansetron (Drug)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: from enrollment to 30, 60, and 90 minutes after drug administration
Mean change in visual analog scale (VAS) of self-rated nausea severity
次要结局
- Analgesia(0, 30, 60, 90 minutes)
- Incidence of side-effects(0, 30, 60, 90 minutes and 24 hours)
- Efficacy in marijuana users(Baseline (time 0))
- QT prolongation(Baseline (time 0) and 90 minutes)
研究者
Jessica J McCoy, MD FACEP
Clinical Associate Professor
Western Michigan University School of Medicine