A Randomized, Controlled Trial of Adding Intravenous Pantoprazole to Conventional Treatment for the Immediate Relief of Dyspeptic Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment
研究概览
简要总结
The purpose of this study is to evaluate the immediate synergistic effect on the relief of severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of oral antacid and antispasmodic agent (the conventional treatment).
详细描述
Acid-related dyspepsia is common among the population. Number of these patients may have so severe symptoms that can lead them to the emergency department. Mixtures of antacid and antispasmodic were widely used over decades to relieve this acute pain with moderate, yet questionable, improvement in pain score. Proton pump inhibitors (PPIs), the novel acid-lowering agents, are undoubtedly effective to reduce acid secretion and control dyspeptic symptoms in short-term and long-term duration. To our knowledge, no previous study was conducted to evaluate the efficacy of such agents on immediate pain relief in patients with severe dyspeptic symptoms in emergency care. Clinically, they are frequently used to treat this circumstance in an unofficial manner since intravenous proton pump inhibitor alone is not yet considered as a well-approved indication to alleviate such condition. Pantoprazole, a proton pump inhibitor, reaches its peak serum concentration within one hour and its acid-lowering effect occurred within first hour following a single intravenous infusion. Thus, it theoretically has rapid onset and prolonged action on acid reduction. Our primary aim of the study is to evaluate the immediate effect of intravenous pantoprazole in addition to the combination of oral antacid and antispasmodic agent (the conventional regimen) on the relief of severe acid-related dyspeptic pain.
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
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of acid-related dyspepsia
- •age 15 to 50 years
排除标准
- •pre-treatment 100-millimeter linear Visual Analog Scale (100-mm VAS) pain scores less than 5.0
- •known cases of malignancies or terminal illnesses
- •known cases of major medical problems
- •allergic to studied drugs
- •contraindicated to hyoscine butylbromide (glaucoma, myasthenia gravis, paralytic ileus, pyloric stenosis, prostatic enlargement, porphyria)
- •received acid antisecretory agents (proton pump inhibitors or histamine-2 receptor antagonists), antispasmodic agents, alcoholic consumption, nonsteroidal anti-inflammatory drugs, aspirin and steroids within 5 days or oral antacids within 4 hours prior to the visit
- •receiving clopidogrel, statins, iron therapies, warfarins, antiretroviral agents, which may have serious drug interaction with the proton pump inhibitors
- •receiving drugs that have strong anticholinergic activities (e.g. acetylcholinesterase inhibitors for Parkinson's or Alzheimer diseases, antihistamines, antispasmodic agents, antipsychotics, skeletal muscle relaxants, tricyclic antidepressants) or decongestants, which may have serious drug interaction with hyoscine butylbromide
- •suspected other alternative diagnoses (e.g. gut obstruction, biliary colic, pancreatitis, hepatitis or localized hepatobiliary infections, etc.)
- •pregnancy or breast-feeding participants
- •did not comprehend the Visual Analog Scale (VAS) evaluation
研究组 & 干预措施
Conventional
Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
干预措施: Normal saline (Drug)
Conventional
Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
干预措施: Oral antacid (Drug)
Conventional
Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
干预措施: Hyoscine butylbromide (Drug)
Pantoprazole
Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
干预措施: Pantoprazole (Drug)
Pantoprazole
Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
干预措施: Oral antacid (Drug)
Pantoprazole
Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
干预措施: Hyoscine butylbromide (Drug)
结局指标
主要结局
Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment
时间窗: 1 hour after treatment
Post-treatment VAS will be consecutively measured every 15 minutes until 1 hour after treatment. Minimal and maximal VAS score of every measurement is 0 to 100 millimeters. VAS scores at 1 hour after treatment were the primary outcome measurement. The patients who had \<50% decrement between pre- and 1-hour post-treatment VAS or post-treatment scores \> 40 millimeters were defined as "Non-responders"(worse outcome). In the same way, those who had ≥ 50% decrement between pre- and 1-hour post-treatment VAS and post-treatment scores≤ 40 millimeters were defined as "Responders" (good outcome).
次要结局
- Number of Participants in the Predefined "Responders"(pretreatment and 1 hour after treatment)
- Number of Participants With Adverse Effect(1 hour after treatment)
- Number of Participants in the Predefined "Non-responders"(pretreatment and 1 hour after treatment)
- Number of Participants That Have Overall Satisfaction on the Treatment(1 hour after treatment)
研究者
Khrongwong Musikatavorn, MD.
Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital.
Chulalongkorn University