Clinical trial NCT01281501: Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole
Official title: A Randomized, Controlled Trial of Adding Intravenous Pantoprazole to Conventional Treatment for the Immediate Relief of Dyspeptic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyspepsia
Emergency
Pain
Keywords: Dyspepsia
Emergency treatment
Pantoprazole
Antacid
Pain measurement
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2011-01-24
Enrollment: 87
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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

Primary outcomes:
measure: Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment
timeFrame: 1 hour after treatment
Secondary outcomes:
measure: Number of Participants in the Predefined "Responders"
timeFrame: pretreatment and 1 hour after treatment
measure: Number of Participants in the Predefined "Non-responders"
timeFrame: pretreatment and 1 hour after treatment
measure: Number of Participants With Adverse Effect
timeFrame: 1 hour after treatment
measure: Number of Participants That Have Overall Satisfaction on the Treatment
timeFrame: 1 hour after treatment
Other outcomes:
Locations:
city: Patumwan
country: Thailand
facility: Emergency Medicine Unit, King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital
name: Khrongwong Musikatavorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.