Clinical trial NCT02985840: Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department
Official title: Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Nausea
Abdominal Pain
Keywords: ondansetron
dexamethasone
Lead sponsor: OhioHealth
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Need for Additional Nausea Medications
timeFrame: 1 hour post intervention
Secondary outcomes:
measure: Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms
timeFrame: 1 hour post intervention
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OhioHealth Doctors Hospital
state: Ohio
Study officials:
affiliation: Attending Physician
name: Andrew Little, D.O.
role: PRINCIPAL_INVESTIGATOR
References: