Official Title

Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    127
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.
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.
Study Started
Jan 28
2014
Primary Completion
Nov 15
2016
Study Completion
Nov 15
2016
Results Posted
Sep 26
2018
Last Update
Sep 26
2018

Drug Ondansetron

Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes

  • Other names: Zofran

Drug Dexamethasone

Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush

  • Other names: Decadron

Ondansetron Active Comparator

Ondansetron (4 mg) followed by two 5 ml normal saline flush

Ondansetron plus dexamethasone Experimental

Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush

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

Summary

Ondansetron

Ondansetron Plus Dexamethasone

All Events

Event Type Organ System Event Term

Number of Participants With Need for Additional Nausea Medications

Effectiveness of intervention will be assessed by the need for additional medications via chart review

Ondansetron

Ondansetron Plus Dexamethasone

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

Ondansetron

Ondansetron Plus Dexamethasone

Total

127
Participants

Age, Continuous

35.21
years (Mean)
Standard Deviation: 12.08

Race and Ethnicity Not Collected

0
Participants

Region of Enrollment

Sex: Female, Male

Overall Study

Ondansetron

Ondansetron Plus Dexamethasone