PainNCT02668094
The Effect of Pregabalin on Pain of Propofol Injection
A study testing Lidocaine, Pregabalin and propofol in people with Pain, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
Pain is a common side effect of propofol injection. The purpose of this study was to compare the efficacy of pregabalin and lidocaine in reducing propofol injection pain. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine, Pregabalin and propofol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2016to Mar 2016
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient underwent elective dental surgery.
Who cannot join
- Patient with a history of adverse response to lidocaine or pregabalin,
- Patient with cardiovascular or respiratory disease,
- Patient who takes any sedatives, analgesics, or anticonvulsants within 24 hours before surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Pain is a common side effect of propofol injection. The purpose of this study was to compare the efficacy of pregabalin and lidocaine in reducing propofol injection pain.
Read the detailed description
In a randomized, double blind, prospective trial, 120 patients were allocated to one of three groups (each n=40) receiving intravenous lidocaine 40mg (group L), oral pregabalin 75 mg (group LP), and oral pregabalin 150 mg (group HP) as pretreatment, followed by injection of 25% of 2 mg/kg propofol. Pain was assessed by a four point scale (0=no, 1=mild, 2=moderate, 3=severe pain).
- Conditions
- Pain
- Being tested
- Lidocaine, Pregabalin, propofol
- Keywords
- propofol, lidocaine, pregabalin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
PregabalinDrug
propofolDrug
| Study group | Role | What they receive |
|---|---|---|
| Group L | Active comparator | Lidocaine 40mg was given intravenously before injection of propofol Receives: Drug: Lidocaine; Drug: propofol |
| Group LP | Active comparator | Pregabalin 75 mg was given orally 2 hour before surgery Receives: Drug: Pregabalin; Drug: propofol |
| Group HP | Active comparator | Pregabalin 150 mg was given orally 2 hour before surgery Receives: Drug: Pregabalin; Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol injection pain
Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after injection of propofol, pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).
Measured: 10 seconds after injection of propofol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016
- Study completionMar 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younghoon Jeon, Kyungpook National University Hospital
- Investigators
- Younghoon Jeon, Dr, Principal investigator, Kyungpook National Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668094
- Sponsor's protocol ID
- 2015-03-037-001
- Status last verified
- May 2016
- First submitted
- 22 Jan 2016
- Last updated
- 11 May 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 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pregabalin on Pain of Propofol Injection
- ClinicalTrials.gov ID
- NCT02668094
- Acronym / sponsor ID
- 2015-03-037-001
- Conditions
- Pain
- Keywords
- propofol, lidocaine, pregabalin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Jan 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.
Pain is a common side effect of propofol injection. The purpose of this study was to compare the efficacy of pregabalin and lidocaine in reducing propofol injection pain.
Detailed description
In a randomized, double blind, prospective trial, 120 patients were allocated to one of three groups (each n=40) receiving intravenous lidocaine 40mg (group L), oral pregabalin 75 mg (group LP), and oral pregabalin 150 mg (group HP) as pretreatment, followed by injection of 25% of 2 mg/kg propofol. Pain was assessed by a four point scale (0=no, 1=mild, 2=moderate, 3=severe pain).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group L | Active comparator | Drug: Lidocaine, Drug: propofolLidocaine 40mg was given intravenously before injection of propofol |
| Group LP | Active comparator | Drug: Pregabalin, Drug: propofolPregabalin 75 mg was given orally 2 hour before surgery |
| Group HP | Active comparator | Drug: Pregabalin, Drug: propofolPregabalin 150 mg was given orally 2 hour before surgery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient underwent elective dental surgery.
Key exclusion criteria (3 listed)
- Patient with a history of adverse response to lidocaine or pregabalin,
- Patient with cardiovascular or respiratory disease,
- Patient who takes any sedatives, analgesics, or anticonvulsants within 24 hours before surgery.
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 |
|---|---|---|
| Lidocaine | Drug | Group L |
| Pregabalin | Drug | Group HP, Group LP |
| propofol | Drug | Group HP, Group L, Group LP |
Primary outcome
Propofol injection pain
Time frame: 10 seconds after injection of propofol
Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after injection of propofol, pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).
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 11 May 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.
Younghoon Jeon, Dr principal investigator
Kyungpook National Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine, Pregabalin and propofol in people with Pain, 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 1 inclusion and 3 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 11 May 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. 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?
Propofol injection pain (time frame: 10 seconds after injection of propofol). 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 11 May 2016.