Needlestick InjuriesNCT02107690
The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration
A study testing Low temperature lidocaine injection, Room temperature lidocaine injection and Body temperature lidocaine injection in people with Needlestick Injuries, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This study will investigate the influence of lidocaine temperature on pain during injection of lidocaine. Each participant will receive three injections subcutaneously on the abdomen with different temperatures. After each injection, participants will be asked to evaluate the pain on a Visual analog scale (0-100 mm). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Needlestick Injuries
- What is being tested?
- Low temperature lidocaine injection, Room temperature lidocaine injection and Body temperature lidocaine injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2014to Jun 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years
Who cannot join
- Kidney, heart or liver disease
- Eczema or psoriasis on injection site
- Neuropathy
- Regular use of painkillers
- Hypersensitivity of Lidocaine
- Pregnancy
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the influence of lidocaine temperature on pain during injection of lidocaine. Each participant will receive three injections subcutaneously on the abdomen with different temperatures. After each injection, participants will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is anticipated that the pain decreases with increasing temperature. The aim of the study is to find a simple method for pain reduction that can be used in clinical practice.
- Conditions
- Needlestick Injuries
- Being tested
- Low temperature lidocaine injection, Room temperature lidocaine injection, Body temperature lidocaine injection
- Keywords
- Injections, Temperature, Pain, Healthy volunteers, Lidocaine
- Medical subject headings
- Needlestick Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low temperature lidocaine injectionProcedure or surgery
4 °C
Room temperature lidocaine injectionProcedure or surgery
20 °C
Body temperature lidocaine injectionProcedure or surgery
37 °C
| Study group | Role | What they receive |
|---|---|---|
| low temperature | Experimental | Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures Receives: Procedure: Low temperature lidocaine injection |
| room temperature | Experimental | Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures Receives: Procedure: Room temperature lidocaine injection |
| body temperature | Experimental | Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures Receives: Procedure: Body temperature lidocaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
(1) visual analog scale 0-100mm, (2) questionnaire
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
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 Needlestick InjuriesStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Vilhjalmur Finsen, prof md, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107690
- Sponsor's protocol ID
- 2013/2297
- Status last verified
- Jun 2016
- First submitted
- 4 Apr 2014
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lundbom JS, Tangen LF, Wago KJ, Skarsvag TI, Ballo S, Hjelseng T, Foss OA, Finsen V. The influence of Lidocaine temperature on pain during subcutaneous injection. J Plast Surg Hand Surg. 2017 Apr;51(2):118-121. doi: 10.1080/2000656X.2016.1194281. Epub 2016 Jun 17.
PubMed 27314148
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration
- ClinicalTrials.gov ID
- NCT02107690
- Acronym / sponsor ID
- 2013/2297
- Conditions
- Needlestick Injuries
- Keywords
- Injections, Temperature, Pain, Healthy volunteers, Lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Apr 2014 (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.
This study will investigate the influence of lidocaine temperature on pain during injection of lidocaine. Each participant will receive three injections subcutaneously on the abdomen with different temperatures. After each injection, participants will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is anticipated that the pain decreases with increasing temperature. The aim of the study is to find a simple method for pain reduction that can be used in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low temperature | Experimental | Procedure: Low temperature lidocaine injectionEach participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures |
| room temperature | Experimental | Procedure: Room temperature lidocaine injectionEach participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures |
| body temperature | Experimental | Procedure: Body temperature lidocaine injectionEach participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-65 years
Key exclusion criteria (7 listed)
- Kidney, heart or liver disease
- Eczema or psoriasis on injection site
- Neuropathy
- Regular use of painkillers
- Hypersensitivity of Lidocaine
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 |
|---|---|---|
| Low temperature lidocaine injection4 °C | Procedure or surgery | low temperature |
| Room temperature lidocaine injection20 °C | Procedure or surgery | room temperature |
| Body temperature lidocaine injection37 °C | Procedure or surgery | body temperature |
Primary outcome
pain
Time frame: 60 seconds
(1) visual analog scale 0-100mm, (2) questionnaire
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 Jun 2016.
- Results publication: PubMed 27314148Lundbom JS, Tangen LF, Wago KJ, Skarsvag TI, Ballo S, Hjelseng T, Foss OA, Finsen V. The influence of Lidocaine temperature on pain during subcutaneous injection. J Plast Surg Hand Surg. 2017 Apr;51(2):118-121. doi: 10.1080/2000656X.2016.1194281. Epub 2016 Jun 17.
- Individual participant dataSharing planned: Undecided
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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.
Vilhjalmur Finsen, prof md study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low temperature lidocaine injection, Room temperature lidocaine injection and Body temperature lidocaine injection in people with Needlestick Injuries, run by Norwegian University of Science and Technology at 1 site in Norway.
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 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 21 Jun 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 Norway. 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?
pain (time frame: 60 seconds). 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 NCT02107690, 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 21 Jun 2016.