Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

• Number of Participants in the Predefined "Responders" [ Time Frame: pretreatment and 1 hour after treatment ] [ Designated as safety issue: No ]
  "Responders" define the participants who have ≥ 50% decrease in post-treatment pain scores compared with the pre-treatment evaluation and also have the post-treatment scores ≤ 40 at the end of the study.
• Number of Participants in the Predefined "Non-responders" [ Time Frame: pretreatment and 1 hour after treatment ] [ Designated as safety issue: No ]
  "Non-responders" defined the participants who had < 50% decrease in post-treatment VAS compared with pre-treatment evaluation or post-treatment scores > 40 at the end of the study.
• Number of Participants With Adverse Effect [ Time Frame: 1 hour after treatment ] [ Designated as safety issue: Yes ]
  The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.
• Number of Participants That Have Overall Satisfaction on the Treatment [ Time Frame: 1 hour after treatment ] [ Designated as safety issue: No ]
  The satisfaction will be assessed by a simple, self-reported yes/no question.

• Number of participants in the predefined "responders" [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  "Responders" define the participants who have ≥ 50% decrease in post-treatment pain scores compared with the pre-treatment evaluation and also have the post-treatment scores ≤ 4 at the end of the study.
• Number of participants in the predefined "non-responders" [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  "Non-responders" defined the participants who had < 50% decrease in post-treatment VAS compared with pre-treatment evaluation or post-treatment scores > 4 at the end of the study.
• Number of participants with adverse effects [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
  The adverse effects include blurred vision, dry mouth, difficulty in urination and diarrhea.
• Number of participants that have overall satisfaction on the treatment [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  The satisfaction will be assessed by a simple, self-reported yes/no question.

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).

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.

• Dyspepsia
• Emergency
• Pain

• Drug: Normal saline
  10 ml of 0.9% sodium chloride solution
• Drug: Pantoprazole
  80 mg of intravenous pantoprazole
  Other Name: Controloc (Protonix)
• Drug: Oral antacid
  30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)
  Other Name: Antacid
• Drug: Hyoscine butylbromide
  20 mg of intravenous hyoscine butylbromide
  Other Name: Buscopan

• Active Comparator: Conventional
  Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
  Interventions:

  • Drug: Normal saline
  • Drug: Oral antacid
  • Drug: Hyoscine butylbromide
• Experimental: Pantoprazole
  Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
  Interventions:

  • Drug: Pantoprazole
  • Drug: Oral antacid
  • Drug: Hyoscine butylbromide

Inclusion Criteria:

• clinical diagnosis of acid-related dyspepsia
• age 15 to 50 years

Exclusion Criteria:

• 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