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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
87
10 ml of 0.9% sodium chloride solution
80 mg of intravenous pantoprazole
30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)
Emergency Medicine Unit, King Chulalongkorn Memorial Hospital
Patumwan, Bangkok, Thailand
Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 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).
Time frame: 1 hour after treatment
Number of Participants in the Predefined "Responders"
"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.
Time frame: pretreatment and 1 hour after treatment
Number of Participants in the Predefined "Non-responders"
"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.
Time frame: pretreatment and 1 hour after treatment
Number of Participants With Adverse Effect
The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.
Time frame: 1 hour after treatment
Number of Participants That Have Overall Satisfaction on the Treatment
The satisfaction will be assessed by a simple, self-reported yes/no question.
Time frame: 1 hour after treatment
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20 mg of intravenous hyoscine butylbromide