PainPhase 4NCT02567916
A Comparison of Injection Pain of Propofol During Endoscopy : LCT Propofol vs MCT/LCT Propofol
A Phase 4 study testing Fresofol and Propofol in people with Pain and Complication of Injection, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by long chain triglyceride propofol versus medium/long chain combinated triglyceride propofol on endoscopy. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Pain, Complication of Injection
- What is being tested?
- Fresofol and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Feb 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age >15 yrs
- ASA (American Society of Anesthesiologists risk class III-IV)I-II
- patients undergoing to gastroscopy
Who cannot join
- significant systemic disease (American Society of Anesthesiologists risk class III-IV)
- history of allergic reactions to any of the study drugs
- chronic use of opioid analgesics
- psychiatric disorder
- arrythmia
- pregnancy
- age <18 yrs
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Keimyung University Dongsan Medical Center
Daegu, 700-712
About this study
The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by long chain triglyceride propofol versus medium/long chain combinated triglyceride propofol on endoscopy.
- Conditions
- Pain, Complication of Injection
- Being tested
- Fresofol, Propofol
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FresofolDrug
PropofolDrug
| Study group | Role | What they receive |
|---|---|---|
| FRESOFOL MCT | Experimental | To compare the incidence and intensity of pain on injection that is caused by propofol (LCT propofol) versus fresofol (MCT/LCT propofol) . Receives: Drug: Fresofol |
| Propofol | Active comparator | The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (LCT propofol) versus fresofol (MCT/LCT propofol). Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Intensity of Pain on Injection That is Caused by Propofol (LCT propofol) Versus the Fresofol (MCT/LCT propofol).
Measured: 2 hours
Secondary outcomes (1)
Patient Satisfaction With Sedation Including the Recall of Pain.
Measured: 2 hours and 5-7days after the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Soo Kim, MD, PhD, Kyungpook National University Hospital
- Investigators
- Eun Soo Kim, MD, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567916
- Sponsor's protocol ID
- 2014-08-026-001
- Status last verified
- Apr 2020
- First submitted
- 23 Mar 2015
- Last updated
- 30 Apr 2020
- Results posted
- No
Publications
Ozawa A, Isono M, Ueno T, Kosaka Y, Nakano T, Inamura M, Kanai A, Okamoto H, Hoka S, Nomiyama S. [Comparison of propofol LCT and propofol MCT/LCT regarding the injection pain at different sites and the memory]. Masui. 2005 Nov;54(11):1241-6. Japanese.
PubMed 16296361
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Injection Pain of Propofol During Endoscopy : LCT Propofol vs MCT/LCT Propofol
- ClinicalTrials.gov ID
- NCT02567916
- Acronym / sponsor ID
- 2014-08-026-001
- Conditions
- Pain, Complication of Injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 5 Oct 2015 (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.
The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by long chain triglyceride propofol versus medium/long chain combinated triglyceride propofol on endoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FRESOFOL MCT | Experimental | Drug: FresofolTo compare the incidence and intensity of pain on injection that is caused by propofol (LCT propofol) versus fresofol (MCT/LCT propofol) . |
| Propofol | Active comparator | Drug: PropofolThe purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (LCT propofol) versus fresofol (MCT/LCT propofol). |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- age >15 yrs
- ASA (American Society of Anesthesiologists risk class III-IV)I-II
- patients undergoing to gastroscopy
Key exclusion criteria (7 listed)
- significant systemic disease (American Society of Anesthesiologists risk class III-IV)
- history of allergic reactions to any of the study drugs
- chronic use of opioid analgesics
- psychiatric disorder
- arrythmia
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 |
|---|---|---|
| Fresofol | Drug | FRESOFOL MCT |
| Propofol | Drug | Propofol |
Primary outcome
Incidence and Intensity of Pain on Injection That is Caused by Propofol (LCT propofol) Versus the Fresofol (MCT/LCT propofol).
Time frame: 2 hours
1 secondary outcome
Patient Satisfaction With Sedation Including the Recall of Pain.
Time frame: 2 hours and 5-7days after the end of the procedure
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 30 Apr 2020.
- Background: PubMed 16296361Ozawa A, Isono M, Ueno T, Kosaka Y, Nakano T, Inamura M, Kanai A, Okamoto H, Hoka S, Nomiyama S. [Comparison of propofol LCT and propofol MCT/LCT regarding the injection pain at different sites and the memory]. Masui. 2005 Nov;54(11):1241-6. Japanese.
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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.
Eun Soo Kim, MD principal investigator
Keimyung University Dongsan Medical Center
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 Fresofol and Propofol in people with Pain and Complication of Injection, run by Kyungpook National University Hospital 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 7 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 30 Apr 2020. 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.
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?
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?
Incidence and Intensity of Pain on Injection That is Caused by Propofol (LCT propofol) Versus the Fresofol (MCT/LCT propofol). (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02567916, which also lists 1 linked publication.
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 30 Apr 2020.