RecruitingPhase 1ACTRN12612000205831

A randomised double blind placebo controlled trial to determine whether topical pre-treatment of injection sites can reduce the pain associated with needles

A randomised double blind placebo controlled trial to determine whether topical pre-treatment of injection sites can reduce the pain associated with needles in adult patients


Sponsor

QuikMed Holdings PTY LTD

Enrollment

50 participants

Start Date

Feb 1, 2012

Study Type

Interventional

Conditions

Summary

The insertion of a needle through the skin, as commonly used to deliver a vaccine or sample blood, into a superficial vein is associated with a degree of pain and discomfort. In addition, many individuals, especially children and their carers, experience strong anxiety associated with, or in expectation of, that pain. This project aims to test the efficacy a simple, fast acting topically applied patented device containing a commonly used local anaesthetic agent, in reducing the pain and discomfort associated with needle insertion. Our hypothesis is that the application of the pad with an active agent for topical anesthesia for 10 minutes is more effective in reducing or eliminating pain and discomfort from needle stick injections compared to application of a placebo pad.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a topical numbing pad applied to the skin for 10 minutes before a needle injection can reduce or eliminate the pain of the injection compared to a pad with no active ingredient (placebo). Needle pain and needle anxiety are very common, especially in children. This device contains lidocaine, a commonly used local anaesthetic. Participants will receive either the active numbing pad or a placebo pad before a standard needle stick. You may be eligible if: - You are between 18 and 65 years old - You are male or female - You do not have a known allergy to lidocaine You may NOT be eligible if: - You are under 18 years old - You have an intellectual or mental impairment - You are pregnant - You are highly dependent on medical care - You have taken pain medication (analgesics) within the last 12 hours - You have a known allergy to lidocaine Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants in the trial (control and treatment groups) will be regularly scheduled patients receiving treatment by their usual physician. This treatment involves the injection of lidocaine (1% Xyloc

Participants in the trial (control and treatment groups) will be regularly scheduled patients receiving treatment by their usual physician. This treatment involves the injection of lidocaine (1% Xylocaine) into the skin to anaesthetise the area being treated. This lidocaine injection causes some pain and discomfort. The intervention involves the placement of a pad that contains the active ingredient to pre-anaesthetise the skin at the site of injection to reduce or eliminate the discomfort felt from the needle stick and Xylocaine injection. The degree of discomfort experienced by both the control (placebo pad) and treatment (pad containing active ingredient) participants will be measured using a self-report Visual Analogue Scale (VAS) and some questions on satisfaction with the procedure.


Locations(1)

Australia

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ACTRN12612000205831