Acid Reflux, Dyspepsia, GERD
Conditions
Keywords
dyspepsia, GERD, Acid Reflux, H2 receptor antagonist, antacid, Maalox, Mylanta, Famotidine
Brief summary
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.
Detailed description
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.
Interventions
DRUGIntravenous Famotidine
Patients in this group will receive 20mg IV Famotidine.
DRUGOral Maalox/ Mylanta
Patients in this group will receive 30 ml Maalox/ Mylanta.
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The research team member assessing verbal pain score will be blinded to the treatment.
Intervention model description
Subjects are divided into two groups and randomly assigned to receive either study drug.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject Age ≥ 18 years of age 2. Patient diagnosed with dyspepsia 3. Present at the ED with upper abdominal pain score of at least 3
Exclusion criteria
1. Hypersensitivity to an ingredient in Maalox/ Mylanta or Famotidine 2. Moderate to Severe Renal Insufficiency (precaution) 3. Kidney Failure 4. Pregnant or Nursing 5. Verbal pain score less than 3 6. Inability to tolerate oral medications 7. Bowel Obstruction 8. Proton pump inhibitor within 2 hours of study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Numerical Pain Score | at 1 hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Rescue Medications | at 1 hour | Investigators will assess frequency of need for rescue medications between groups. |
| Satisfaction with Assigned Medication | at 1 hour | 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. |
Countries
United States
Contacts
CONTACTAdam Singer, MD
Outcome results
None listed