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NCT02107690 Clinical Trial

The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration

Needlestick Injuries Clinical Trial

Official title:
The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02107690
Other study ID # 2013/2297
Secondary ID
Status Completed
Phase N/A
First received April 4, 2014
Last updated June 20, 2016
Start date February 2014
Est. completion date June 2014

Study information
Verified date June 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 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.

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Low temperature lidocaine injection
4 °C
• Room temperature lidocaine injection
20 °C
• Body temperature lidocaine injection
37 °C

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)

Lundbom JS, Tangen LF, Wågø KJ, Skarsvåg TI, Ballo S, Hjelseng T, Foss OA, Finsen V. The influence of Lidocaine temperature on pain during subcutaneous injection. J Plast Surg Hand Surg. 2016 Jun 17:1-4. [Epub ahead of print] — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary pain (1) visual analog scale 0-100mm, (2) questionnaire 60 seconds No
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