The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration

NCT ID: NCT02107690

Last Updated: 2016-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Needlestick Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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low temperature

Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures

Group Type EXPERIMENTAL

Low temperature lidocaine injection

Intervention Type PROCEDURE

4 °C

room temperature

Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures

Group Type EXPERIMENTAL

Room temperature lidocaine injection

Intervention Type PROCEDURE

20 °C

body temperature

Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures

Group Type EXPERIMENTAL

Body temperature lidocaine injection

Intervention Type PROCEDURE

37 °C

Interventions

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Low temperature lidocaine injection

4 °C

Intervention Type PROCEDURE

Room temperature lidocaine injection

20 °C

Intervention Type PROCEDURE

Body temperature lidocaine injection

37 °C

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vilhjalmur Finsen, prof md

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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Department of Neuroscience, NTNU

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 27314148 (View on PubMed)

Other Identifiers

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2013/2297

Identifier Type: -

Identifier Source: org_study_id

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