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

Primary Purpose

Nausea, Abdominal Pain

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ondansetron
Dexamethasone
Sponsored by
OhioHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea focused on measuring ondansetron, dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OhioHealth Doctors Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ondansetron

Ondansetron plus dexamethasone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants With Need for Additional Nausea Medications
Effectiveness of intervention will be assessed by the need for additional medications via chart review

Secondary Outcome Measures

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

Full Information

First Posted
October 30, 2016
Last Updated
August 28, 2018
Sponsor
OhioHealth
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1. Study Identification

Unique Protocol Identification Number
NCT02985840
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Unable to access EMR for patients enrolled prior to 8/2015 for data collection
Study Start Date
January 28, 2014 (Actual)
Primary Completion Date
November 15, 2016 (Actual)
Study Completion Date
November 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OhioHealth

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Abdominal Pain
Keywords
ondansetron, dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ondansetron
Arm Type
Active Comparator
Arm Description
Ondansetron (4 mg) followed by two 5 ml normal saline flush
Arm Title
Ondansetron plus dexamethasone
Arm Type
Experimental
Arm Description
Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush
Primary Outcome Measure Information:
Title
Number of Participants With Need for Additional Nausea Medications
Description
Effectiveness of intervention will be assessed by the need for additional medications via chart review
Time Frame
1 hour post intervention
Secondary Outcome Measure Information:
Title
Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms
Description
Effectiveness of intervention will be assessed by the resolution of symptoms via chart review
Time Frame
1 hour post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Little, D.O.
Organizational Affiliation
Attending Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
OhioHealth Doctors Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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