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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Active Comparator | Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline |
|
| Pantoprazole | Experimental | Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Drug | 10 ml of 0.9% sodium chloride solution |
| |
| 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 |
| 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" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khrongwong Musikatavorn, MD | Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Medicine Unit, King Chulalongkorn Memorial Hospital | Patumwan | Bangkok | 11130 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22463973 | Result | Musikatavorn K, Tansangngam P, Lumlertgul S, Komindr A. A randomized controlled trial of adding intravenous pantoprazole to conventional treatment for the immediate relief of dyspeptic pain. Am J Emerg Med. 2012 Nov;30(9):1737-42. doi: 10.1016/j.ajem.2012.02.001. Epub 2012 Mar 29. |
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We analyzed the data for all enrolled patients with the intention-to-treat principles.
Enrollment began in January, 1 2011 and finished at the end October, 31 2011 in the Emergency Department of King Chulalongkorn Memorial Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional | Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline |
| FG001 | Pantoprazole | Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional | Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline |
| BG001 | Pantoprazole | Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All enrolled patients were analyzed with the intention-to-treat principles. | Posted | Mean | Standard Deviation | millimeter | 1 hour after treatment |
|
1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional | Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| transient blurred vision | Eye disorders | Non-systematic Assessment |
1. This was a small, single-centered study. 2. Exaggerated self-evaluation of the patients' pain score and the physician's expectation of a "good outcome" may also have biased the report. 3. The short-term recurrence of the pain was not studied.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Khrongwong Musikatavorn, MD | Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital. | +662-256-4000 | 4553-5 | kmusikatavorn@yahoo.com |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| D004630 | Emergencies |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D000077402 | Pantoprazole |
| D000863 | Antacids |
| D002086 | Butylscopolammonium Bromide |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Pantoprazole |
| Drug |
80 mg of intravenous pantoprazole |
|
|
| Oral antacid | Drug | 30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide) |
|
|
| Hyoscine butylbromide | Drug | 20 mg of intravenous hyoscine butylbromide |
|
|
"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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pretreatment 100-millimeter visual analog scale (VAS) scores | Self-marked pain scores on the 100-millimeter VAS lines were assessed by the patients before treatment. The minimal and maximal scores were between 0-100 millimeters. Good responders (good outcome) defined those had ≥ 50% decreases in post-treatment VAS compared with the pre-treatment evaluation and post-treatment scores ≤ 40 millimeters at the end of the study. Non-responders (worse outcome) defined those who had <50% decreases in post-treatment VAS compared with the pre-treatment evaluation or post-treatment scores > 40 millimeters at the end of the study. | Mean | Standard Deviation | millimeters |
|
| OG001 | Pantoprazole | Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole |
|
|
|
| Secondary | 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. | Posted | Number | participants | pretreatment and 1 hour after treatment |
|
|
|
| Secondary | 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. | Posted | Number | participants | pretreatment and 1 hour after treatment |
|
|
|
| Secondary | Number of Participants With Adverse Effect | The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea. | Not Posted | 1 hour after treatment |
| Secondary | Number of Participants That Have Overall Satisfaction on the Treatment | The satisfaction will be assessed by a simple, self-reported yes/no question. | Posted | Number | participants | 1 hour after treatment |
|
|
|
| 0 |
| 44 |
| 31 |
| 44 |
| EG001 | Pantoprazole | Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole | 0 | 43 | 30 | 43 |
| dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | Non-systematic Assessment |
|
| palpitation | Cardiac disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
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| D010335 | Pathologic Processes |
| D009461 | Neurologic Manifestations |
| D053799 |
| 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D005765 | Gastrointestinal Agents |
| D045506 | Therapeutic Uses |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |