NauseaPhase 4NCT02985840
Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department
A Phase 4 study testing Ondansetron and Dexamethasone in people with Nausea and Abdominal Pain, run by OhioHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea, Abdominal Pain
- What is being tested?
- Ondansetron and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2014to 15 Nov 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chief Complaint of nausea or abdominal pain with nausea
- Inability to tolerate oral nausea medication
- Patients with a negative pregnancy test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Ondansetron, Dexamethasone
- Keywords
- ondansetron, dexamethasone
- Medical subject headings
- Nausea, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
DexamethasoneDrug
Also called Decadron
Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Active comparator | Ondansetron (4 mg) followed by two 5 ml normal saline flush Receives: Drug: Ondansetron |
| Ondansetron plus dexamethasone | Experimental | Ondansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush Receives: Drug: Ondansetron; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Need for Additional Nausea Medications
Effectiveness of intervention will be assessed by the need for additional medications via chart review
Measured: 1 hour post intervention
Secondary outcomes (1)
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
Measured: 1 hour post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start28 Jan 2014
- Primary completion15 Nov 2016
- Study completion15 Nov 2016
Why it stopped: Unable to access EMR for patients enrolled prior to 8/2015 for data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Little, OhioHealth
- Investigators
- Andrew Little, D.O., Principal investigator, Attending Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985840
- Sponsor's protocol ID
- 1066755 (13-0056)
- Status last verified
- Aug 2018
- First submitted
- 30 Oct 2016
- Last updated
- 26 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ondansetron Versus Dexamethasone/Ondansetron to Treat Acute Nausea in the Emergency Department
- ClinicalTrials.gov ID
- NCT02985840
- Acronym / sponsor ID
- 1066755 (13-0056)
- Conditions
- Nausea, Abdominal Pain
- Keywords
- ondansetron, dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to access EMR for patients enrolled prior to 8/2015 for data collection
- Enrolment
- 127 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Study start
- 28 Jan 2014 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 15 Nov 2016 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Posted 26 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Active comparator | Drug: OndansetronOndansetron (4 mg) followed by two 5 ml normal saline flush |
| Ondansetron plus dexamethasone | Experimental | Drug: Ondansetron, Drug: DexamethasoneOndansetron (4 mg), followed by dexamethasone (4 mg), followed by a single 5 ml normal saline flush |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chief Complaint of nausea or abdominal pain with nausea
- Inability to tolerate oral nausea medication
- Patients with a negative pregnancy test
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OndansetronAlso: ZofranPatients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes | Drug | Ondansetron, Ondansetron plus dexamethasone |
| DexamethasoneAlso: DecadronPatients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush | Drug | Ondansetron plus dexamethasone |
Primary outcome
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
1 secondary outcome
Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms
Time frame: 1 hour post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Little, D.O. principal investigator
Attending Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron and Dexamethasone in people with Nausea and Abdominal Pain, run by OhioHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Need for Additional Nausea Medications (time frame: 1 hour post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.