Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

Chulalongkorn University

Status and phase: Completed; Phase 4

Conditions: Dyspepsia; Pain; Emergency

Treatments: Drug: Normal saline; Drug: Hyoscine butylbromide; Drug: Pantoprazole; Drug: Oral antacid

Study type: Interventional

Funder types: Other

Identifiers

NCT01281501

619/2010

Details and patient eligibility

About

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).

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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87 participants in 2 patient groups

Conventional

Active Comparator group

Description:

Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline

Treatment:

Drug: Oral antacid

Drug: Normal saline

Drug: Hyoscine butylbromide

Pantoprazole

Experimental group

Description:

Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole

Treatment:

Drug: Oral antacid

Drug: Pantoprazole

Drug: Hyoscine butylbromide