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

NCT ID: NCT02985840

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-28
• Study Completion Date: 2016-11-15

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.

Conditions

Nausea; Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ondansetron

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

Group Type: ACTIVE_COMPARATOR

Ondansetron

Intervention Type: DRUG

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

Ondansetron plus dexamethasone

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

Group Type: EXPERIMENTAL

Ondansetron

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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

Interventions

Ondansetron

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

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

Other Intervention Names

Zofran; Decadron

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OhioHealth

OTHER

Sponsor Role: lead

Responsible Party

Andrew Little

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Little, D.O.

Role: PRINCIPAL_INVESTIGATOR

Attending Physician

Locations

OhioHealth Doctors Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

1066755 (13-0056)

Identifier Type: -

Identifier Source: org_study_id