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Trial record 62 of 978 for:    scale | Norway

The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration

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ClinicalTrials.gov Identifier: NCT02107690
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Needlestick Injuries Procedure: Low temperature lidocaine injection Procedure: Room temperature lidocaine injection Procedure: Body temperature lidocaine injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Influence of Lidocaine Temperature on Pain During Subcutaneous Administration
Study Start Date : February 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: low temperature
Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures
Procedure: Low temperature lidocaine injection
4 °C

Experimental: room temperature
Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures
Procedure: Room temperature lidocaine injection
20 °C

Experimental: body temperature
Each participant will receive three lidocaine injections subcutaneously on the abdomen at different temperatures
Procedure: Body temperature lidocaine injection
37 °C




Primary Outcome Measures :
  1. pain [ Time Frame: 60 seconds ]
    (1) visual analog scale 0-100mm, (2) questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107690


Locations
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Norway
Department of Neuroscience, NTNU
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Study Director: Vilhjalmur Finsen, prof md Norwegian University of Science and Technology

Publications of Results:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02107690     History of Changes
Other Study ID Numbers: 2013/2297
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Norwegian University of Science and Technology:
Injections
Temperature
Pain
Healthy volunteers
Lidocaine

Additional relevant MeSH terms:
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Needlestick Injuries
Wounds, Stab
Wounds, Penetrating
Wounds and Injuries
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action