Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Dyspepsia Emergency Pain |
Drug: Normal saline Drug: Pantoprazole Drug: Oral antacid Drug: Hyoscine butylbromide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Controlled Trial of Adding Intravenous Pantoprazole to Conventional Treatment for the Immediate Relief of Dyspeptic Pain |
- Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment [ Time Frame: 1 hour after treatment ] [ Designated as safety issue: No ]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).
- 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.
| Enrollment: | 87 |
| Study Start Date: | January 2011 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Conventional
Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
|
Drug: Normal saline
10 ml of 0.9% sodium chloride solution
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
|
|
Experimental: Pantoprazole
Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
|
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
|
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.
Eligibility| Ages Eligible for Study: | 15 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Thailand | |
| Emergency Medicine Unit, King Chulalongkorn Memorial Hospital | |
| Patumwan, Bangkok, Thailand, 11130 | |
| Principal Investigator: | Khrongwong Musikatavorn, MD | Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital |
More Information
Publications:
| Responsible Party: | Khrongwong Musikatavorn, MD., Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital., Chulalongkorn University |
| ClinicalTrials.gov Identifier: | NCT01281501 History of Changes |
| Other Study ID Numbers: | 619/2010 |
| Study First Received: | January 17, 2011 |
| Results First Received: | April 8, 2012 |
| Last Updated: | July 25, 2012 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Chulalongkorn University:
|
Dyspepsia Emergency treatment Pantoprazole Antacid Pain measurement |
Additional relevant MeSH terms:
|
Dyspepsia Emergencies Signs and Symptoms, Digestive Signs and Symptoms Disease Attributes Pathologic Processes Antacids Anti-Ulcer Agents Pantoprazole Butylscopolammonium Bromide Scopolamine Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gastrointestinal Agents |
Therapeutic Uses Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Mydriatics Adjuvants, Anesthesia Central Nervous System Agents Proton Pump Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013