The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration
Primary Purpose
Needlestick Injuries
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Low temperature lidocaine injection
Room temperature lidocaine injection
Body temperature lidocaine injection
Sponsored by
About this trial
This is an interventional treatment trial for Needlestick Injuries focused on measuring Injections, Temperature, Pain, Healthy volunteers, Lidocaine
Eligibility Criteria
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
Sites / Locations
- Department of Neuroscience, NTNU
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
low temperature
room temperature
body temperature
Arm Description
Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures
Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures
Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures
Outcomes
Primary Outcome Measures
pain
(1) visual analog scale 0-100mm, (2) questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT02107690
First Posted
April 4, 2014
Last Updated
June 20, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02107690
Brief Title
The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration
Official Title
The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Needlestick Injuries
Keywords
Injections, Temperature, Pain, Healthy volunteers, Lidocaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low temperature
Arm Type
Experimental
Arm Description
Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures
Arm Title
room temperature
Arm Type
Experimental
Arm Description
Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures
Arm Title
body temperature
Arm Type
Experimental
Arm Description
Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures
Intervention Type
Procedure
Intervention Name(s)
Low temperature lidocaine injection
Intervention Description
4 °C
Intervention Type
Procedure
Intervention Name(s)
Room temperature lidocaine injection
Intervention Description
20 °C
Intervention Type
Procedure
Intervention Name(s)
Body temperature lidocaine injection
Intervention Description
37 °C
Primary Outcome Measure Information:
Title
pain
Description
(1) visual analog scale 0-100mm, (2) questionnaire
Time Frame
60 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilhjalmur Finsen, prof md
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neuroscience, NTNU
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27314148
Citation
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.
Results Reference
result
Learn more about this trial
The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration
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