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

Overview

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.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Participant)
• Study Primary Completion Date: November 15, 2016

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

• Drug: Ondansetron
  • Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
• Drug: Dexamethasone
  • Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush

Arms, Groups and Cohorts

• Active Comparator: Ondansetron
  • Ondansetron (4 mg) followed by two 5 ml normal saline flush
• Experimental: Ondansetron plus dexamethasone
  • Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush

Clinical Trial Outcome Measures

Primary Measures

• Number of Participants With Need for Additional Nausea Medications
  • Time Frame: 1 hour post intervention
  • Effectiveness of intervention will be assessed by the need for additional medications via chart review

Secondary Measures

• Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms
  • Time Frame: 1 hour post intervention
  • Effectiveness of intervention will be assessed by the resolution of symptoms via chart review

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • OhioHealth
• Provider of Information About this Clinical Study
  • Principal Investigator: Andrew Little, Attending Physician – OhioHealth
• Overall Official(s)
  • Andrew Little, D.O., Principal Investigator, Attending Physician