NauseaNCT01527890
Effect of Intravenous Patient-controlled Analgesia (IV-PCA) With Fentanyl in Adults for Acute Postoperative Pain Control
An observational study of Nausea and Vomiting, run by Yonsei University at 1 site in South Korea.
Trial summary
In this retrospective study, the investigators examined incidence and risk factors of postoperative nausea and vomiting (PONV) in patients with fentanyl-based intravenous patient-controlled analgesia (IV-PCA). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- What is being tested?
- Fentanyl
- Type of treatment
- Injection or infusion
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Oct 2012
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with Intravenous Fentanyl Patient-controlled Analgesia for postoperative pain control
Who may be able to join
- Adults between 20 to 60 years old
- Date from 1st, May 2011 to 31st, October 2011
- Patients with fentanyl based intravenous patient-controlled analgesia for postoperative pain control
Who cannot join
- Reoperation within 48 hours
- Patients who cannot express numerical rating scale for pain due to sedation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul, 125-070
Yon Hee Shim, MD, PhD, 82-2-2019-3547 ext. 3547, tren125@yuhs.ac
About this study
In this retrospective study, the investigators examined incidence and risk factors of postoperative nausea and vomiting (PONV) in patients with fentanyl-based intravenous patient-controlled analgesia (IV-PCA).
- Being tested
- Fentanyl
- Keywords
- intravenous patient-controlled analgesia, IV PCA
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
intravenous patient-controlled analgesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yon Hee Shim, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527890
- Sponsor's protocol ID
- 3-2011-0238
- Status last verified
- Feb 2012
- First submitted
- 27 Jan 2012
- Last updated
- 7 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Patient-controlled Analgesia (IV-PCA) With Fentanyl in Adults for Acute Postoperative Pain Control
- ClinicalTrials.gov ID
- NCT01527890
- Acronym / sponsor ID
- 3-2011-0238
- Keywords
- intravenous patient-controlled analgesia, IV PCA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 7 Feb 2012 (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.
In this retrospective study, the investigators examined incidence and risk factors of postoperative nausea and vomiting (PONV) in patients with fentanyl-based intravenous patient-controlled analgesia (IV-PCA).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with Intravenous Fentanyl Patient-controlled Analgesia for postoperative pain control
Key inclusion criteria (3 listed)
- Adults between 20 to 60 years old
- Date from 1st, May 2011 to 31st, October 2011
- Patients with fentanyl based intravenous patient-controlled analgesia for postoperative pain control
Key exclusion criteria (2 listed)
- Reoperation within 48 hours
- Patients who cannot express numerical rating scale for pain due to sedation
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 |
|---|---|---|
| Fentanylintravenous patient-controlled analgesia | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea and Vomiting, run by Yonsei University at 1 site in South Korea.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Feb 2012. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yon Hee Shim, MD, PhD (82-2-2019-3547 ext. 3547, tren125@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 7 Feb 2012.