Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

Phase 4

Completed

Interventions: Drug: Normal saline
Drug: Pantoprazole
Drug: Oral antacid
Drug: Hyoscine butylbromide

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Conventional	Normal saline	Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
Pantoprazole	Hyoscine butylbromide	Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
Conventional	Oral antacid	Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
Pantoprazole	Oral antacid	Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
Conventional	Hyoscine butylbromide	Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
Pantoprazole	Pantoprazole	Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole

Primary Outcome Measures

Name	Time	Method
Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants in the Predefined "Responders"	pretreatment and 1 hour after treatment	"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 With Adverse Effect	1 hour after treatment	The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.
Number of Participants in the Predefined "Non-responders"	pretreatment and 1 hour after treatment	"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 That Have Overall Satisfaction on the Treatment	1 hour after treatment	The satisfaction will be assessed by a simple, self-reported yes/no question.