Abdominal Pain, Nausea
Conditions
Keywords
ondansetron, dexamethasone
Brief summary
Nausea is a common complaint in patients who present to the emergency department (ED). Although the number of conditions that can present with nausea are numerous, the mainstay of treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but also its availability. One of the major drawbacks to using this form is that it often needs to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV ondansetron given with IV dexamethasone (Decadron) as another viable option when treating patients with nausea in the emergency department. Previous studies in patients undergoing surgical procedures have shown that when IV dexamethasone is given with IV ondansetron to post-operative patients they have less nausea and vomiting than ondansetron alone, and were even found to show decreased post-operative pain associated with nausea. It has also been shown to decrease the need to re-dose antiemetic medication. Although this combination has not been tested in the emergency department it is believed by these investigators that the additional use of dexamethasone may decrease the need to use repeated doses of ondansetron. The investigators believe this may change the way physicians currently approach the nauseated patient in regards to treatment. That rather than possibly giving multiple doses of one medication over and over to reduce a patient's nausea, physicians can give two medications together at one time. The investigators hope to demonstrate that by giving intravenous dexamethasone and ondansetron together, it may be possible to reduce the number of patients who need additional doses of nausea medication.
Detailed description
Nausea is a common complaint in patients who present to the emergency department (ED). Although the number of conditions that can present with nausea are numerous, the mainstay of treatment has become intravenous ondansetron (Zofran), not only due to its rapid onset but also its availability. One of the major drawbacks to using this form is that it often needs to be redosed. This study aims to compare intravenous (IV) ondansetron alone versus IV ondansetron given with IV dexamethasone (Decadron) as another viable option when treating patients with nausea in the emergency department.
Interventions
DRUGOndansetron
Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
DRUGDexamethasone
Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush
Sponsors
OhioHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chief Complaint of nausea or abdominal pain with nausea * Inability to tolerate oral nausea medication * Patients with a negative pregnancy test
Exclusion criteria
* Patients younger than 18 years of age * Patient's chief complaint includes headache, chest pain, or dizziness * Patients with whom there are contraindications to using the studied medicine (allergies, known adrenal disease) * Blood sugar greater than 300 * Non-English speaking subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Need for Additional Nausea Medications | 1 hour post intervention | Effectiveness of intervention will be assessed by the need for additional medications via chart review |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms | 1 hour post intervention | Effectiveness of intervention will be assessed by the resolution of symptoms via chart review |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ondansetron Ondansetron (4 mg) followed by two 5 ml normal saline flush
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes | 64 |
| Ondansetron Plus Dexamethasone Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush
Ondansetron: Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
Dexamethasone: Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush | 63 |
| Total | 127 |
Baseline characteristics
| Characteristic | Ondansetron Plus Dexamethasone | Total | Ondansetron |
|---|---|---|---|
| Age, Continuous | 34.65 years STANDARD_DEVIATION 12.75 | 35.21 years STANDARD_DEVIATION 12.08 | 35.77 years STANDARD_DEVIATION 11.46 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 63 Participants | 127 Participants | 64 Participants |
| Sex: Female, Male Female | 43 Participants | 88 Participants | 45 Participants |
| Sex: Female, Male Male | 20 Participants | 39 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 63 |
| other Total, other adverse events | 0 / 64 | 0 / 63 |
| serious Total, serious adverse events | 0 / 64 | 0 / 63 |
Outcome results
Primary
Number of Participants With Need for Additional Nausea Medications
Effectiveness of intervention will be assessed by the need for additional medications via chart review
Time frame: 1 hour post intervention
Population: Evaluation of this outcome (need for additional medications within 1 hr of intervention) required additional chart review, which was not performed. As such, this outcome was not collected or analyzed, and cannot be reported.
Secondary
Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms
Effectiveness of intervention will be assessed by the resolution of symptoms via chart review
Time frame: 1 hour post intervention
Population: Evaluation of this outcome (resolution of symptoms following intervention) required additional chart review, which was not collected. As such, this outcome was not collected or analyzed, and cannot be reported.