Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000205831
Ethics application status
Approved
Date submitted
27/01/2012
Date registered
20/02/2012
Date last updated
20/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised double blind placebo controlled trial to determine whether topical pre-treatment of injection sites can reduce the pain associated with needles
Scientific title
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
Secondary ID [1] 262826 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain reduction associated with needle insertion for venous puncture or dermatological procedures 270550 0
Condition category
Condition code
Anaesthesiology 270710 270710 0 0
Pain management
Skin 270711 270711 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 269179 0
Treatment: Devices
Comparator / control treatment
The intervention involves the placement of a 2cm diameter pad onto the skin at the site where the regularly scheduled Xylocaine will be injected for a period of 10min.
The treatment group will receive a 2cm diameter pad containing the active ingredient.
The control group will receive a 2cm diameter pad containing the a placebo solution.
Control group
Placebo

Outcomes
Primary outcome [1] 269424 0
Participant assessment of the level of pain associated with that injection evaluated by a VAS scale.
Timepoint [1] 269424 0
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 [1] 287604 0
Participant questions on satisfaction with experience i.e. would they request pad treatment again?
Timepoint [1] 287604 0
After needle injection of Xylocaine and scheduled procedure is complete

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The method used to implement the random allocation sequence will be numbered envelopes prepared off site prior to randomisation and the sequence will be concealed until this time.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation method using a computer generated random number table to generate treatment or control number sequence*. A research nurse with no association to the study will be responsible for assigning the participants to their groups.

*Beller EM, Gebski V, and Keech AC. Randomisation in clinical trials. Medical Journal of Australia 2002, 177; 565-567.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269650 0
Commercial sector/Industry
Name [1] 269650 0
QuikMed Holdings PTY LTD
Country [1] 269650 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
QuikMed Holdings PTY LTD
Address
Box 1385
Brisbane QLD 4001
Country
Australia
Secondary sponsor category [1] 283505 0
Individual
Name [1] 283505 0
A/Prof Diann Eley
Address [1] 283505 0
The University of Queensland
School of Medicine
288 Herston Road
Brisbane 4006
Queensland
Country [1] 283505 0
Australia
Other collaborator category [1] 260478 0
University
Name [1] 260478 0
The University of Queensland
Address [1] 260478 0
School of Medicine
288 Herston road,
Brisbane QLD 4006
Country [1] 260478 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286573 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 286573 0
Research Ethics
Research and Innovation Division
Cumbrae Stewart Bldg
St Lucia, Brisbane 4072
Queensland
Ethics committee country [1] 286573 0
Australia
Date submitted for ethics approval [1] 286573 0
01/11/2011
Approval date [1] 286573 0
29/11/2011
Ethics approval number [1] 286573 0
2011001161

Summary
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.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 33011 0
Address 33011 0
Country 33011 0
Phone 33011 0
Fax 33011 0
Email 33011 0
Contact person for public queries
Name 16258 0
Associate Professor Diann Eley
Address 16258 0
School of Medicine
The University of Queensland
288 Herston Road
Herston QLD 4006
Country 16258 0
Australia
Phone 16258 0
+61 7 3346 5103
Fax 16258 0
+61 7 3365 5433
Email 16258 0
d.eley@uq.edu.au
Contact person for scientific queries
Name 7186 0
Associate Professor Diann Eley
Address 7186 0
School of Medicine
The University of Queensland
288 Herston Road
Herston QLD 4006
Country 7186 0
Australia
Phone 7186 0
+61 7 3346 5103
Fax 7186 0
+61 7 3365 5433
Email 7186 0
d.eley@uq.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.