Famotidine and Antacids for Treatment of Dyspepsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous Famotidine, Oral Maalox/ Mylanta.
- Who it may be relevant to
- Registry conditions: Dyspepsia, GERD, Acid Reflux. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing Intravenous Famotidine and Oral Antacids in the Treatment of Dyspepsia in the Emergency Department
Overview
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
- Drug Intravenous Famotidine
Patients in this group will receive 20mg IV Famotidine. - Drug Oral Maalox/ Mylanta
Patients in this group will receive 30 ml Maalox/ Mylanta.
Primary outcome measures
- Verbal Numerical Pain Score [Time frame: at 1 hour]
Secondary outcome measures (2)
- Need for Rescue Medications [Time frame: at 1 hour]
- Satisfaction with Assigned Medication [Time frame: at 1 hour]
Eligibility criteria
Inclusion criteria
- Subject Age ≥ 18 years of age
- Patient diagnosed with dyspepsia
- Present at the ED with upper abdominal pain score of at least 3
Exclusion criteria
- Hypersensitivity to an ingredient in Maalox/ Mylanta or Famotidine
- Moderate to Severe Renal Insufficiency (precaution)
- Kidney Failure
- Pregnant or Nursing
- Verbal pain score less than 3
- Inability to tolerate oral medications
- Bowel Obstruction
- Proton pump inhibitor within 2 hours of study treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stony Brook University Hospital — Stony Brook
Identifiers
NCT: NCT06241183 · IRB2023-00188