- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02107690
The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration
June 20, 2016 updated by: Norwegian University of Science and Technology
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway
- Department of neuroscience, NTNU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-65 years
Exclusion Criteria:
- Kidney, heart or liver disease
- Eczema or psoriasis on injection site
- Neuropathy
- Regular use of painkillers
- Hypersensitivity of Lidocaine
- Pregnancy
- Diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: low temperature
Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures
|
4 °C
|
Experimental: room temperature
Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures
|
20 °C
|
Experimental: body temperature
Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures
|
37 °C
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain
Time Frame: 60 seconds
|
(1) visual analog scale 0-100mm, (2) questionnaire
|
60 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Vilhjalmur Finsen, prof md, Norwegian University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
April 4, 2014
First Submitted That Met QC Criteria
April 4, 2014
First Posted (Estimate)
April 8, 2014
Study Record Updates
Last Update Posted (Estimate)
June 21, 2016
Last Update Submitted That Met QC Criteria
June 20, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Wounds, Stab
- Wounds, Penetrating
- Needlestick Injuries
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 2013/2297
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Needlestick Injuries
-
University of California, San DiegoNational Institute on Drug Abuse (NIDA); Open Society Foundations; UCSD Center... and other collaboratorsCompletedOccupational Needlestick InjuriesMexico
-
Acibadem UniversityCompletedNeedlestick InjuriesTurkey
-
Centro de Atenção ao Assoalho PélvicoRecruitingLaxity; Skin | Skin Hyperpigmentation | Needlestick PunctureBrazil
-
Medical University of South CarolinaCompletedNeedlestick InjuriesUnited States
-
Nemera La VerpilliereCompleted
-
Samsung Medical CenterCompletedNeedle Stick InjuriesKorea, Republic of
-
Hospital Universiti Sains MalaysiaActive, not recruiting
-
Medical University of South CarolinaCompletedNeedlestick Injuries | Glove PerforationsUnited States
-
HTL-Strefa S.A.Completed
-
HTL-Strefa S.A.Completed
Clinical Trials on Low temperature lidocaine injection
-
Universidad Católica San Antonio de MurciaRecruiting
-
Fudan UniversityNot yet recruitingCognitive Function | Cardiovascular System | Respiratory SystemChina
-
Nanjing First Hospital, Nanjing Medical UniversityCompletedUnstable Angina PectorisChina
-
Northwestern UniversityActive, not recruiting
-
Beijing Tiantan HospitalActive, not recruiting
-
University of AarhusCompletedEnd Stage Renal Disease on DialysisDenmark
-
Maastricht University Medical CenterDutch Diabetes Research FoundationCompletedDiabetes Mellitus | Polyneuropathies | Arthropathy, NeurogenicNetherlands
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityCompleted
-
Nanjing First Hospital, Nanjing Medical UniversityCompleted
-
The Third Xiangya Hospital of Central South UniversityRecruitingSmall Probe Ultrasound Endoscopy | The Water TemperatureChina