NCT01281501

Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

A Randomized, Controlled Trial of Adding Intravenous Pantoprazole to Conventional Treatment for the Immediate Relief of Dyspeptic Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 15 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dyspepsia
• Emergency
• Pain

Interventions

Type	Name	Description
DRUG	Normal saline	10 ml of 0.9% sodium chloride solution
DRUG	Pantoprazole	80 mg of intravenous pantoprazole
DRUG	Oral antacid	30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)
DRUG	Hyoscine butylbromide	20 mg of intravenous hyoscine butylbromide

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-01-24
• Last updated: 2013-09-18
• Results posted: 2012-07-27

Locations

1 site across 1 country: Thailand