Postoperative Nausea and VomitingNCT00199329
Antiemetic Effect of the Addition of Ondansetron to the Morphine Solution in Patient-Controlled Analgesia (PCA)
A study testing ondansetron adding in PCA in people with Postoperative Nausea and Vomiting, run by Khon Kaen University at 1 site in Thailand.
Trial summary
PCA morphine always introduces nausea and vomiting during the postoperative period. Ondansetron can reduce PONV (postoperative nausea vomiting). We, the researchers at Khon Kaen University, are trying to add ondansetron in PCA morphine. Patients receive a small dose of ondansetron when they request morphine. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- ondansetron adding in PCA
- How many people
- 160 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2005to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 15-60 years old
Who cannot join
- History of motion sickness, smoking
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Khon Kaen university, Srinagarind Hospital
Muang, Changwat Khon Kaen, 40002
About this study
PCA morphine always introduces nausea and vomiting during the postoperative period. Ondansetron can reduce PONV (postoperative nausea vomiting). We, the researchers at Khon Kaen University, are trying to add ondansetron in PCA morphine. Patients receive a small dose of ondansetron when they request morphine.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- ondansetron adding in PCA
- Keywords
- ondansetron, PCA
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ondansetron adding in PCADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PONV
Measured: 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Investigators
- Polpun Boonmak, MD, Study director, lecturer in Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199329
- Sponsor's protocol ID
- I48027
- Status last verified
- Oct 2007
- First submitted
- 14 Sep 2005
- Last updated
- 21 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiemetic Effect of the Addition of Ondansetron to the Morphine Solution in Patient-Controlled Analgesia (PCA)
- ClinicalTrials.gov ID
- NCT00199329
- Acronym / sponsor ID
- I48027
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- ondansetron, PCA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jan 2005
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PCA morphine always introduces nausea and vomiting during the postoperative period. Ondansetron can reduce PONV (postoperative nausea vomiting). We, the researchers at Khon Kaen University, are trying to add ondansetron in PCA morphine. Patients receive a small dose of ondansetron when they request morphine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Age between 15-60 years old
Key exclusion criteria (1 listed)
- History of motion sickness, smoking
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 |
|---|---|---|
| ondansetron adding in PCA | Drug | – |
Primary outcome
PONV
Time frame: 24 hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
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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.
Polpun Boonmak, MD study director
lecturer in Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ondansetron adding in PCA in people with Postoperative Nausea and Vomiting, run by Khon Kaen University at 1 site in Thailand.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Mar 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 Thailand. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PONV (time frame: 24 hr). 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 21 Mar 2018.