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The H0 hypothesis of the study is there is no difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.
The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.
Dyspepsia is one of the common complaints in emergency department. Proton pomp inhibitors, H2 receptor blockers and anti-acids are common drugs for treating dyspepsia in emergency department. However there is no study in the emergency department comparing the effectiveness of these drugs. So the investigators planned this study which drug is effective in these patients in order to provide a cost-effective treatment in dyspeptic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pantoprazole | Experimental | Intravenous pantoprazole 40 mg flacon |
|
| ranitidine | Active Comparator | Intravenous ranitidine 50 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug | 33 patients |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale Score | The investigators are measuring the change of pain from the baseline to the 30th and 60th minutes by visual anologue scale (VAS). Visual Analogue Scale measurement is between 0 (no pain) and 100 (worst pain). A decrease of 13 or 16 mm in VAS score is accepted as a minimum clinically significant change in pain. | 30th and 60th minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Additional Drug | The investigators are measuring the need for additional drug at the end of 60 minutes. | 60 th minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cenker Eken, Proffesor | Akdeniz University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akdeniz University | Antalya | 07050 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2202240 | Background | Welling LR, Watson WA. The emergency department treatment of dyspepsia with antacids and oral lidocaine. Ann Emerg Med. 1990 Jul;19(7):785-8. doi: 10.1016/s0196-0644(05)81704-4. |
| Label | URL |
|---|---|
| The web adress of the organization which this study is conducted. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pantoprazole | Intravenous pantoprazole 40 mg flacon Pantoprazole: 33 patients |
| FG001 | Ranitidine | Intravenous ranitidine 50 mg Ranitidine: 33 patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pantoprazole | Intravenous pantoprazole 40 mg flacon Pantoprazole: 33 patients |
| BG001 | Ranitidine | Intravenous ranitidine 50 mg Ranitidine: 33 patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogue Scale Score | The investigators are measuring the change of pain from the baseline to the 30th and 60th minutes by visual anologue scale (VAS). Visual Analogue Scale measurement is between 0 (no pain) and 100 (worst pain). A decrease of 13 or 16 mm in VAS score is accepted as a minimum clinically significant change in pain. | Posted | Mean | Standard Deviation | Visual Analogue Scale | 30th and 60th minutes |
|
60 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pantoprazole | Intravenous pantoprazole 40 mg flacon Pantoprazole: 33 patients |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cenker Eken | Akdeniz University | 00905321593948 | cenkereken@akdeniz.edu.tr |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| D011899 | Ranitidine |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Ranitidine |
| Drug |
33 patients |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Need for Additional Drug | The investigators are measuring the need for additional drug at the end of 60 minutes. | Posted | Number | participants | 60 th minute |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Ranitidine | Intravenous ranitidine 50 mg Ranitidine: 33 patients | 0 | 33 | 0 | 33 |
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| D010335 | Pathologic Processes |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005663 | Furans |