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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
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Needlestick Injuries focused on measuring Injections, Temperature, Pain, Healthy volunteers, Lidocaine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
April 4, 2014
Last Updated
June 20, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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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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