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

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).

Study Overview

• Status: Completed
• Conditions: Pain; Dyspepsia; Emergency
• Intervention / Treatment: Drug: Normal saline; Drug: Oral antacid; Drug: Hyoscine butylbromide; Drug: Pantoprazole

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Patumwan, Bangkok, Thailand, 11130
      • Emergency Medicine Unit, King Chulalongkorn Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Antacid; Drug: Hyoscine butylbromide; 20 mg of intravenous hyoscine butylbromide; Other Names: Buscopan
EXPERIMENTAL: Pantoprazole; Oral antacid, 20 mg of intravenous hyoscine butylbromide, 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); Other Names: Antacid; Drug: Hyoscine butylbromide; 20 mg of intravenous hyoscine butylbromide; Other Names: Buscopan; Drug: Pantoprazole; 80 mg of intravenous pantoprazole; Other Names: Controloc (Protonix)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment	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).	1 hour after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants in the Predefined "Responders"	"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.	pretreatment and 1 hour after treatment
Number of Participants in the Predefined "Non-responders"	"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.	pretreatment and 1 hour after treatment
Number of Participants With Adverse Effect	The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.	1 hour after treatment
Number of Participants That Have Overall Satisfaction on the Treatment	The satisfaction will be assessed by a simple, self-reported yes/no question.	1 hour after treatment

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Khrongwong Musikatavorn, MD, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: January 17, 2011
• First Submitted That Met QC Criteria: January 20, 2011
• First Posted (ESTIMATE): January 24, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 18, 2013
• Last Update Submitted That Met QC Criteria: September 9, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Pain measurement; Pantoprazole; Dyspepsia; Emergency treatment; Antacid
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Signs and Symptoms, Digestive; Emergencies; Dyspepsia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Proton Pump Inhibitors; Mydriatics; Scopolamine; Antacids; Pantoprazole; Butylscopolammonium Bromide; Anti-Ulcer Agents
• Other Study ID Numbers: 619/2010