Comparing Intravenous Famotidine and Oral Antacids in the Treatment of Dyspepsia in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Verbal Numerical Pain Score
研究概览
简要总结
The aim of this study is to compare intravenous famotidine, an H2 receptor antagonist, and Maalox/ Mylanta, an oral antacid, in treatment of dyspepsia in the emergency department. The goal of this study is to reduce patients' pain based on the verbal numerical pain scale. The anticipated outcome is for pain levels in both groups to decrease. It is expected that antacids will improve symptoms more quickly and to a greater degree within an hour of taking medication based on the results of similar studies.
详细描述
This study will be conducted in the Emergency Department at Stony Brook University Hospital. Investigators intend to enroll approximately 80 patients who present to the emergency department with dyspepsia symptoms. The patients will be randomized to one of two groups: one group will receive 20 mg of intravenous famotidine and the other will receive 30 ml of oral Maalox/ Mylanta. The verbal numeric pain score (VNP) will be used to measure pain at 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after administration of the study drug. Pain severity assessments will be performed by an investigator blinded to study treatment. Data will also be collected regarding demographic, clinical information, patient satisfaction and the need for rescue medications in each of the two study groups at the end of the 60-minute study period. At the end of the study period, the patients may be treated with additional analgesia at the discretion of their ED provider.
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 (Outcomes Assessor)
盲法说明
The research team member assessing verbal pain score will be blinded to the treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject Age ≥ 18 years of age
- •Patient diagnosed with dyspepsia
- •Present at the ED with upper abdominal pain score of at least 3
排除标准
- •Hypersensitivity to an ingredient in Maalox/ Mylanta or Famotidine
- •Moderate to Severe Renal Insufficiency (precaution)
- •Kidney Failure
- •Pregnant or Nursing
- •Verbal pain score less than 3
- •Inability to tolerate oral medications
- •Bowel Obstruction
- •Proton pump inhibitor within 2 hours of study treatment
研究组 & 干预措施
Intravenous Famotidine
Patients in this group will receive 20 mg of intravenous famotidine.
干预措施: Intravenous Famotidine (Drug)
Oral Maalox
Patients in the group will receive 30 ml of oral Maalox/ Mylanta.
干预措施: Oral Maalox/ Mylanta (Drug)
结局指标
主要结局
Verbal Numerical Pain Score
时间窗: at 1 hour
Patients will be asked to rate their pain on a scale of 0 to 10 with 0 indicating no pain and 10 indicating the worst pain imaginable every 15 minutes for 60 minutes.
次要结局
- Need for Rescue Medications(at 1 hour)
- Satisfaction with Assigned Medication(at 1 hour)
研究者
Adam Singer
Professor and Interim Chair of the Department of Emergency Medicine
Stony Brook University