Dyspepsia
Conditions
Keywords
dyspepsia, pantoprazole, ranitidine, emergency department
Brief summary
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.
Detailed description
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.
Interventions
DRUGPantoprazole
33 patients
DRUGRanitidine
33 patients
Sponsors
Akdeniz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Epigastric pain * Older than 18 years old
Exclusion criteria
* Diagnosed as cholecystitis, pancreatitis, myocardial infarction, etc.. at the end of the emergency deparment evaluation period. * Pregnancy * Patients with unstable vital signs * Patients used anti-acid, H2 receptor blockers and proton pomp inhibitors in the last one hour. * Allergy to H2 receptor blockers and proton pomp inhibitors. * Patients denied to give inform consent and who are illiterate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale Score | 30th and 60th minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Additional Drug | 60 th minute | The investigators are measuring the need for additional drug at the end of 60 minutes. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pantoprazole Intravenous pantoprazole 40 mg flacon
Pantoprazole: 33 patients | 33 |
| Ranitidine Intravenous ranitidine 50 mg
Ranitidine: 33 patients | 33 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Diagnosed with an other pathology | 2 | 2 |
Baseline characteristics
| Characteristic | Ranitidine | Pantoprazole | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 33 Participants | 66 Participants |
| Age, Continuous | 34.8 years STANDARD_DEVIATION 13.9 | 38.4 years STANDARD_DEVIATION 16.4 | 36.6 years STANDARD_DEVIATION 15 |
| Region of Enrollment Turkey | 33 participants | 33 participants | 66 participants |
| Sex: Female, Male Female | 22 Participants | 18 Participants | 40 Participants |
| Sex: Female, Male Male | 11 Participants | 15 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
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.
Time frame: 30th and 60th minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pantoprazole | Visual Analogue Scale Score | VAS score changes at 60 minutes | 39.6 Visual Analogue Scale | Standard Deviation 39 |
| Pantoprazole | Visual Analogue Scale Score | VAS scores changes at 30 minutes | 27.6 Visual Analogue Scale | Standard Deviation 28 |
| Ranitidine | Visual Analogue Scale Score | VAS score changes at 60 minutes | 42.3 Visual Analogue Scale | Standard Deviation 25 |
| Ranitidine | Visual Analogue Scale Score | VAS scores changes at 30 minutes | 28.3 Visual Analogue Scale | Standard Deviation 23 |
Secondary
Need for Additional Drug
The investigators are measuring the need for additional drug at the end of 60 minutes.
Time frame: 60 th minute
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pantoprazole | Need for Additional Drug | 13 participants |
| Ranitidine | Need for Additional Drug | 8 participants |