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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02107742
Other study ID # 2013/2297C
Secondary ID
Status Completed
Phase N/A
First received April 4, 2014
Last updated December 28, 2016
Start date February 2014
Est. completion date June 2014

Study information

Verified date December 2016
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Normal speed lidocaine injection
30 seconds
Slow lidocaine injection
speed 45 seconds
Fast lidocaine injection
speed 15 seconds

Locations

Country Name City State
Norway Department of Neuroscience, NTNU Trondheim

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Tangen LF, Lundbom JS, Skarsvåg TI, Wågø 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Visual Analog scale 0-100 mm
Questionnaire
60 seconds No
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