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

• ClinicalTrials.gov Identifier: NCT02985840
• Recruitment Status: Terminated
• First Posted: December 7, 2016
• Results First Posted: September 26, 2018
• Last Update Posted: September 26, 2018
• Sponsor: OhioHealth
• Information provided by (Responsible Party): Andrew Little, OhioHealth

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.

Condition or disease	Intervention/treatment	Phase
Nausea; Abdominal Pain	Drug: Ondansetron; Drug: Dexamethasone	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 127 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department
• Actual Study Start Date: January 28, 2014
• Actual Primary Completion Date: November 15, 2016
• Actual Study Completion Date: November 15, 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Ondansetron; Ondansetron (4 mg) followed by two 5 ml normal saline flush	Drug: Ondansetron; Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes; Other Name: Zofran
Experimental: Ondansetron plus dexamethasone; Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush	Drug: Ondansetron; Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes; Other Name: Zofran; Drug: Dexamethasone; Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush; Other Name: Decadron

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Ohio

OhioHealth Doctors Hospital

Columbus, Ohio, United States, 43228

Sponsors and Collaborators

OhioHealth

Investigators

• Principal Investigator: Andrew Little, D.O.; Attending Physician

More Information

• Responsible Party: Andrew Little, Attending Physician, OhioHealth
• ClinicalTrials.gov Identifier: NCT02985840
• Other Study ID Numbers: 1066755 (13-0056)
• First Posted: December 7, 2016
• Results First Posted: September 26, 2018
• Last Update Posted: September 26, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Andrew Little, OhioHealth:

ondansetron; dexamethasone

Additional relevant MeSH terms:

Emergencies; Nausea; Abdominal Pain; Disease Attributes; Pathologic Processes; Signs and Symptoms, Digestive; Pain; Neurologic Manifestations; Dexamethasone; Ondansetron; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Antipruritics; Dermatologic Agents; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants