None listed
Conditions
Brief 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.
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
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.
Sponsors
QuikMed Holdings PTY LTD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Age 18+ Sex Male and Female The inclusion criteria include; People whose primary language is other than English (LOTE) People in existing dependent or unequal relationships Aboriginal and/or Torres Strait Islander peoples People who may be involved in illegal activity may be coincidentally recruited into this project. People who do not speak English or are Aboriginal and/or Torres Strait Islanders will not be specifically excluded. We will not be asking personal questions about relationships and illegal activity.
Exclusion criteria
The exclusion criteria include: Children and/or young people (ie. <18 years) People with an intellectual or mental impairment Women who are pregnant and the human foetus People highly dependent on medical care Subjects who have taken analgesic medication within the last 12 hours Known allergy to lidocaine We need to be sure the patients fully understand the implications of their participation when they enter the trial. In order to avoid any potential association with pregnancy problems we will exclude any women known to be pregnant. People highly dependent on medical care are unlikely to attend the study site.
Outcome results
None listed