Dyspepsia, Emergency, Pain
Conditions
Keywords
Dyspepsia, Emergency treatment, Pantoprazole, Antacid, Pain measurement
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.
Interventions
DRUGNormal saline
10 ml of 0.9% sodium chloride solution
DRUGPantoprazole
80 mg of intravenous pantoprazole
DRUGOral antacid
30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)
20 mg of intravenous hyoscine butylbromide
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in the Predefined Responders | pretreatment and 1 hour after treatment | 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 | pretreatment and 1 hour after treatment | 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 | 1 hour after treatment | The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea. |
| Number of Participants That Have Overall Satisfaction on the Treatment | 1 hour after treatment | The satisfaction will be assessed by a simple, self-reported yes/no question. |
Countries
Thailand
Participant flow
Recruitment details
Enrollment began in January, 1 2011 and finished at the end October, 31 2011 in the Emergency Department of King Chulalongkorn Memorial Hospital
Pre-assignment details
We analyzed the data for all enrolled patients with the intention-to-treat principles.
Participants by arm
| Arm | Count |
|---|---|
| Conventional Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline | 44 |
| Pantoprazole Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole | 43 |
| Total | 87 |
Baseline characteristics
| Characteristic | Conventional | Pantoprazole | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 40 Participants | 83 Participants |
| Age Continuous | 29.8 years STANDARD_DEVIATION 8.1 | 29.4 years STANDARD_DEVIATION 9.2 | 29.6 years STANDARD_DEVIATION 8.6 |
| Pretreatment 100-millimeter visual analog scale (VAS) scores | 64 millimeters STANDARD_DEVIATION 13 | 64 millimeters STANDARD_DEVIATION 16 | 64 millimeters STANDARD_DEVIATION 14 |
| Region of Enrollment Thailand | 44 participants | 43 participants | 87 participants |
| Sex: Female, Male Female | 33 Participants | 35 Participants | 68 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 31 / 44 | 30 / 43 |
| serious Total, serious adverse events | 0 / 44 | 0 / 43 |
Outcome results
Primary
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).
Time frame: 1 hour after treatment
Population: All enrolled patients were analyzed with the intention-to-treat principles.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional | Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment | 17 millimeter | Standard Deviation 24 |
| Pantoprazole | Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment | 19 millimeter | Standard Deviation 23 |
Comparison: Null hypothesis is that the treatment with pantoprazole arm is not different in immediate relief of acute, severe dyspeptic pain compared with conventional arm.p-value: 0.695% CI: [-12.7, 7.4]t-test, 2 sided
Secondary
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.
Time frame: pretreatment and 1 hour after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional | Number of Participants in the Predefined Non-responders | 8 participants |
| Pantoprazole | Number of Participants in the Predefined Non-responders | 11 participants |
Secondary
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.
Time frame: pretreatment and 1 hour after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional | Number of Participants in the Predefined Responders | 36 participants |
| Pantoprazole | Number of Participants in the Predefined Responders | 32 participants |
Secondary
Number of Participants That Have Overall Satisfaction on the Treatment
The satisfaction will be assessed by a simple, self-reported yes/no question.
Time frame: 1 hour after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional | Number of Participants That Have Overall Satisfaction on the Treatment | 34 participants |
| Pantoprazole | Number of Participants That Have Overall Satisfaction on the Treatment | 34 participants |
Secondary
Number of Participants With Adverse Effect
The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.
Time frame: 1 hour after treatment