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Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

Primary Purpose

Dyspepsia, Emergency, Pain

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Normal saline
Pantoprazole
Oral antacid
Hyoscine butylbromide
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring Dyspepsia, Emergency treatment, Pantoprazole, Antacid, Pain measurement

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Emergency Medicine Unit, King Chulalongkorn Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional

Pantoprazole

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
Number of Participants With Adverse Effect
The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.
Number of Participants That Have Overall Satisfaction on the Treatment
The satisfaction will be assessed by a simple, self-reported yes/no question.

Full Information

First Posted
January 17, 2011
Last Updated
September 9, 2013
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT01281501
Brief Title
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Emergency, Pain
Keywords
Dyspepsia, Emergency treatment, Pantoprazole, Antacid, Pain measurement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
Arm Title
Pantoprazole
Arm Type
Experimental
Arm Description
Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
10 ml of 0.9% sodium chloride solution
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Other Intervention Name(s)
Controloc (Protonix)
Intervention Description
80 mg of intravenous pantoprazole
Intervention Type
Drug
Intervention Name(s)
Oral antacid
Other Intervention Name(s)
Antacid
Intervention Description
30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)
Intervention Type
Drug
Intervention Name(s)
Hyoscine butylbromide
Other Intervention Name(s)
Buscopan
Intervention Description
20 mg of intravenous hyoscine butylbromide
Primary Outcome Measure Information:
Title
Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment
Description
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).
Time Frame
1 hour after treatment
Secondary Outcome Measure Information:
Title
Number of Participants in the Predefined "Responders"
Description
"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.
Time Frame
pretreatment and 1 hour after treatment
Title
Number of Participants in the Predefined "Non-responders"
Description
"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.
Time Frame
pretreatment and 1 hour after treatment
Title
Number of Participants With Adverse Effect
Description
The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.
Time Frame
1 hour after treatment
Title
Number of Participants That Have Overall Satisfaction on the Treatment
Description
The satisfaction will be assessed by a simple, self-reported yes/no question.
Time Frame
1 hour after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khrongwong Musikatavorn, MD
Organizational Affiliation
Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Medicine Unit, King Chulalongkorn Memorial Hospital
City
Patumwan
State/Province
Bangkok
ZIP/Postal Code
11130
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
22463973
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.
Results Reference
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Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

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