Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole
Information source: Chulalongkorn University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyspepsia; Emergency; Pain
Intervention: Normal saline (Drug); Pantoprazole (Drug); Oral antacid (Drug); Hyoscine butylbromide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Chulalongkorn University Official(s) and/or principal investigator(s): Khrongwong Musikatavorn, MD, Principal Investigator, Affiliation: Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital
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).
Clinical Details
Official title: A Randomized, Controlled Trial of Adding Intravenous Pantoprazole to Conventional Treatment for the Immediate Relief of Dyspeptic Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment
Secondary outcome: Number of Participants in the Predefined "Responders"Number of Participants in the Predefined "Non-responders" Number of Participants With Adverse Effect Number of Participants That Have Overall Satisfaction on the 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.
Eligibility
Minimum age: 15 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Emergency Medicine Unit, King Chulalongkorn Memorial Hospital, Patumwan, Bangkok 11130, Thailand
Additional Information
Starting date: January 2011
Last updated: September 9, 2013
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