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
QuikMed Holdings PTY LTD
50 participants
Feb 1, 2012
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
Plain Language Summary
Simplified for easier understanding
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% 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)
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ACTRN12612000205831