PainPhase 4NCT02770690
the Effect of Spray on Propofol Injection Pain
A Phase 4 study testing ethyl chloride spray and lidocaine in people with Pain, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
While propofol is widely used an anesthetic induction medication, it causes the mild to moderate pain. Investigators will investigate the effect of ethyl chloride spray on propofol injection pain. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- ethyl chloride spray and lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Nov 2016
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the female patients undergoing hysteroscopy
Who cannot join
- the patients who are pregnant, have Raynaud's syndrome, or receive the pain killer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Ethyl Chloride Spray on Propofol Injection Pain
While propofol is widely used an anesthetic induction medication, it causes the mild to moderate pain. Investigators will investigate the effect of ethyl chloride spray on propofol injection pain.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethyl chloride sprayDrug
Also called spray
apply the spray for 5 seconds on the dorsal hand before propofol iv injection
lidocaineDrug
apply lidocaine under the tourniquet state before propofol iv injection
placeboDrug
Also called normal saline
apply normal saline before propofol iv injection
| Study group | Role | What they receive |
|---|---|---|
| spray | Experimental | apply the ethyl chloride spray before propofol injection Receives: Drug: ethyl chloride spray |
| lidocaine | Active comparator | apply the lidocaine 0.5 mg/kg under the touniquette state before propofol injection Receives: Drug: lidocaine |
| placebo | Placebo comparator | apply the saline before propofol injection Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
propofol injection pain
Propofol injection pain will be measured using the VAS (Visual analogue scale; 0cm=no pain, 10cm=the worst pain)
Measured: right after the propofol injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Eun Moon, The Catholic University of Korea
- Investigators
- Youngeun Moon, MD, Principal investigator, Assitant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770690
- Sponsor's protocol ID
- CMC 2016-1
- Status last verified
- Apr 2016
- First submitted
- 26 Apr 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Ethyl Chloride Spray on Propofol Injection Pain
- ClinicalTrials.gov ID
- NCT02770690
- Acronym / sponsor ID
- CMC 2016-1
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 12 May 2016 (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.
While propofol is widely used an anesthetic induction medication, it causes the mild to moderate pain. Investigators will investigate the effect of ethyl chloride spray on propofol injection pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| spray | Experimental | Drug: ethyl chloride sprayapply the ethyl chloride spray before propofol injection |
| lidocaine | Active comparator | Drug: lidocaineapply the lidocaine 0.5 mg/kg under the touniquette state before propofol injection |
| placebo | Placebo comparator | Drug: placeboapply the saline before propofol injection |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the female patients undergoing hysteroscopy
Key exclusion criteria (1 listed)
- the patients who are pregnant, have Raynaud's syndrome, or receive the pain killer
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 |
|---|---|---|
| ethyl chloride sprayAlso: sprayapply the spray for 5 seconds on the dorsal hand before propofol iv injection | Drug | spray |
| lidocaineapply lidocaine under the tourniquet state before propofol iv injection | Drug | lidocaine |
| placeboAlso: normal salineapply normal saline before propofol iv injection | Drug | placebo |
Primary outcome
propofol injection pain
Time frame: right after the propofol injection
Propofol injection pain will be measured using the VAS (Visual analogue scale; 0cm=no pain, 10cm=the worst pain)
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 7 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Youngeun Moon, MD principal investigator
Assitant Professor
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 ethyl chloride spray and lidocaine in people with Pain, run by The Catholic University of Korea 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 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 7 Dec 2016. 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. Some participants in this study may receive a placebo. 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?
propofol injection pain (time frame: right after the propofol injection). 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 7 Dec 2016.