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

NCT02985840 | Terminated Phase 4 Results

• 1 other identifier: 1066755 (13-0056)
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Abdominal Pain

Keywords

ondansetron; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Need for Additional Nausea Medications

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

  1 hour post intervention

Secondary Outcomes (1)

• Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms

  1 hour post intervention

Study Arms (2)

Ondansetron

ACTIVE COMPARATOR

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

Drug: Ondansetron

Ondansetron plus dexamethasone

EXPERIMENTAL

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

Drug: Ondansetron; Drug: Dexamethasone

Interventions

Ondansetron DRUG

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

Also known as: Zofran

Ondansetron; Ondansetron plus dexamethasone

Dexamethasone DRUG

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

Also known as: Decadron

Ondansetron plus dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chief Complaint of nausea or abdominal pain with nausea
• Inability to tolerate oral nausea medication
• Patients with a negative pregnancy test

You may not qualify if:

• 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

Sponsors & Collaborators

• OhioHealth: lead

Study Sites (1)

OhioHealth Doctors Hospital

Columbus, Ohio, 43228, United States

Location

MeSH Terms

Conditions

Nausea; Abdominal Pain

Interventions

Ondansetron; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Limitations and Caveats

Due to the transfer of electronic medical record systems, investigators were unable to access data from patients who were enrolled prior to August 2015 for the retrospective chart review component of this study.

Results Point of Contact

• Title: Chelsea Blessing, PhD
• Organization: OhioHealth Research Institutute

chelsea.blessing@ohiohealth.com

(513) 461-1772

Study Officials

• Andrew Little, D.O.

  Attending Physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: October 30, 2016
• First Posted: December 7, 2016
• Study Start: January 28, 2014
• Primary Completion: November 15, 2016
• Study Completion: November 15, 2016
• Last Updated: September 26, 2018
• Results First Posted: September 26, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)