Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Controlled Trial of Adding Intravenous Pantoprazole to Conventional Treatment for the Immediate Relief of Dyspeptic Pain

Conditions
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Dyspepsia, Emergency, Pain

Intervention / Treatment
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* Drug: Normal saline
* Drug: Pantoprazole
* Drug: Oral antacid
* Drug: Hyoscine butylbromide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional<br>Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline | Drug: Normal saline<br>* 10 ml of 0.9% sodium chloride solution<br>Drug: Oral antacid<br>* 30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)<br>* Other names: Antacid;Drug: Hyoscine butylbromide<br>* 20 mg of intravenous hyoscine butylbromide<br>* Other names: Buscopan;|
| Experimental: Pantoprazole<br>Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole | Drug: Pantoprazole<br>* 80 mg of intravenous pantoprazole<br>* Other names: Controloc (Protonix);Drug: Oral antacid<br>* 30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)<br>* Other names: Antacid;Drug: Hyoscine butylbromide<br>* 20 mg of intravenous hyoscine butylbromide<br>* Other names: Buscopan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 hour after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 1 hour after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyspepsia, Emergency treatment, Pantoprazole, Antacid, Pain measurement