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

Phase 1

Recruiting

• Conditions: Pain reduction associated with needle insertion for venous puncture or dermatological procedures; Anaesthesiology - Pain management; Skin - Other skin conditions

• Registration Number: ACTRN12612000205831
• Lead Sponsor: QuikMed Holdings PTY LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Age18+
SexMale 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participant assessment of the level of pain associated with that injection evaluated by a VAS scale.[Interventions will be performed for 10min in both groups; endpoint will be the injection of their scheduled Xylocaine and participant assessment of the level of pain associated with that injection.]

Secondary Outcome Measures

Name	Time	Method
Participant questions on satisfaction with experience i.e. would they request pad treatment again?[After needle injection of Xylocaine and scheduled procedure is complete]