Back to resultsThe Influence of Injection Speed on Pain During Administration of Local Anaesthetic.
Primary Purpose
Needlestick Injuries
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Normal speed lidocaine injection
Slow lidocaine injection
Fast lidocaine injection
Sponsored by
About this trial
This is an interventional treatment trial for Needlestick Injuries focused on measuring Injections, Time factors, 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 Type
Experimental
Arm Label
Injection speed
Arm Description
each participant receives 3 injections with the same amount of lidocaine subcutaneously on the abdomen, given over 15, 30 and 45 seconds
Outcomes
Primary Outcome Measures
Pain
Visual Analog scale 0-100 mm
Questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT02107742
First Posted
April 4, 2014
Last Updated
December 28, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02107742
Brief Title
The Influence of Injection Speed on Pain During Administration of Local Anaesthetic.
Official Title
The Influence of Injection Speed on Pain During Administration of Local Anaesthetic.
Study Type
Interventional
2. Study Status
Record Verification Date
December 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 injection speed on pain during injection of lidocaine. It is anticipated that a longer injection time will lead to less pain for the patient during the injection. This hypothesis will be tested on healthy volunteers, who will each receive three injections with the same amount of lidocaine subcutaneously on the abdomen. The injections will be given over 15, 30 and 45 seconds. After each injection, the subject will be asked to evaluate the pain on a Visual analog scale (0-100 mm). 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, Time factors, Pain, Healthy volunteers, Lidocaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Injection speed
Arm Type
Experimental
Arm Description
each participant receives 3 injections with the same amount of lidocaine subcutaneously on the abdomen, given over 15, 30 and 45 seconds
Intervention Type
Procedure
Intervention Name(s)
Normal speed lidocaine injection
Intervention Description
30 seconds
Intervention Type
Procedure
Intervention Name(s)
Slow lidocaine injection
Intervention Description
speed 45 seconds
Intervention Type
Procedure
Intervention Name(s)
Fast lidocaine injection
Intervention Description
speed 15 seconds
Primary Outcome Measure Information:
Title
Pain
Description
Visual Analog scale 0-100 mm
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
Citations:
PubMed Identifier
26414074
Citation
Tangen LF, Lundbom JS, Skarsvag TI, Wago KJ, Ballo S, Hjelseng T, Finsen V. The influence of injection speed on pain during injection of local anaesthetic. J Plast Surg Hand Surg. 2016;50(1):7-9. doi: 10.3109/2000656X.2015.1058269. Epub 2015 Sep 28.
Results Reference
result
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The Influence of Injection Speed on Pain During Administration of Local Anaesthetic.
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