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The aim of this study is to compare intravenous famotidine, an H2 receptor antagonist, and Maalox/ Mylanta, an oral antacid, in treatment of dyspepsia in the emergency department. The goal of this study is to reduce patients' pain based on the verbal numerical pain scale. The anticipated outcome is for pain levels in both groups to decrease. It is expected that antacids will improve symptoms more quickly and to a greater degree within an hour of taking medication based on the results of similar studies.
This study will be conducted in the Emergency Department at Stony Brook University Hospital. Investigators intend to enroll approximately 80 patients who present to the emergency department with dyspepsia symptoms. The patients will be randomized to one of two groups: one group will receive 20 mg of intravenous famotidine and the other will receive 30 ml of oral Maalox/ Mylanta. The verbal numeric pain score (VNP) will be used to measure pain at 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after administration of the study drug. Pain severity assessments will be performed by an investigator blinded to study treatment. Data will also be collected regarding demographic, clinical information, patient satisfaction and the need for rescue medications in each of the two study groups at the end of the 60-minute study period. At the end of the study period, the patients may be treated with additional analgesia at the discretion of their ED provider.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Famotidine | Active Comparator | Patients in this group will receive 20 mg of intravenous famotidine. |
|
| Oral Maalox | Active Comparator | Patients in the group will receive 30 ml of oral Maalox/ Mylanta. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Famotidine | Drug | Patients in this group will receive 20mg IV Famotidine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Numerical Pain Score | Patients will be asked to rate their pain on a scale of 0 to 10 with 0 indicating no pain and 10 indicating the worst pain imaginable every 15 minutes for 60 minutes. | at 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Rescue Medications | Investigators will assess frequency of need for rescue medications between groups. | at 1 hour |
| Satisfaction with Assigned Medication | Investigators will gather data regarding patient satisfaction with their assigned treatment using a 5 item likert scale from very dissatisfied (1), dissatisfied (2) neither satisfied nor dissatisfied (3), satisfied (4) and very satisfied (5). The outcome will be measured as the percentages of patients choosing very satisfied or satisfied with their assigned medications. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Singer, MD | Contact | 6314447857 | adam.singer@stonybrookmedicine.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Hospital | Recruiting | Stony Brook | New York | 11794 | United States |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
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| ID | Term |
|---|---|
| D006635 | Histamine H2 Antagonists |
| C013591 | aluminum hydroxide, magnesium hydroxide, drug combination |
| C008570 | aluminum hydroxide, magnesium hydroxide, simethicone drug combination |
| D000863 | Antacids |
| ID | Term |
|---|---|
| D006633 | Histamine Antagonists |
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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Subjects are divided into two groups and randomly assigned to receive either study drug.
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The research team member assessing verbal pain score will be blinded to the treatment.
| Oral Maalox/ Mylanta | Drug | Patients in this group will receive 30 ml Maalox/ Mylanta. |
|
|
| at 1 hour |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D005765 | Gastrointestinal Agents |
| D045506 | Therapeutic Uses |