Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000612314
Ethics application status
Approved
Date submitted
18/08/2008
Date registered
5/12/2008
Date last updated
5/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is pain and anxiety from finger-pricks reduced by topical amethocaine
Scientific title
Is pain and anxiety from finger-pricks reduced by topical amethocaine in subjects requiring blood tests
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
health conditions requiring blood tests 3575 0
Condition category
Condition code
Blood 3734 3734 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a crossover study. All subjects had one fingerprick without gel to obtain baseline score for pain and how scared they were. They were then randomly allocated to receive either amethocaine 4% gel or placebo prior to the next finger prick. From 1 day to 1 month later they experienced the alternative treatment prior to the third finger prick.
Intervention code [1] 3289 0
Behaviour
Comparator / control treatment
placebo zinc oxide powder mixed with 2% methycellulose base
Control group
Placebo

Outcomes
Primary outcome [1] 4634 0
0-7 Bieri faces scale was used as a self report pain measurement
Timepoint [1] 4634 0
during finger prick
Secondary outcome [1] 7830 0
Anxiety was assessed using a 5 point Likert scale from extremely anxious to not anxious.
Timepoint [1] 7830 0
during finger prick

Eligibility
Key inclusion criteria
Eligible subjects with leukaemia and solid organ tumours minimum age 5 years
maximum age 18years
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to speak english

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment with central randomisation by computer. All participants had first finger prick with no gel then random allocation of either active or placebo gel on next 2 finger pricks
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation of study gel tubes randomised in blocks. participants randomised to one type on 1st finger prick, the other tpye on next finger prick
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/04/2001
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] 3751 0
Self funded/Unfunded
Name [1] 3751 0
Country [1] 3751 0
Primary sponsor type
Hospital
Name
Royal Childrens Hospital
Address
Flemington Rd
parkville
Vic
3052
Country
Australia
Secondary sponsor category [1] 3364 0
None
Name [1] 3364 0
Address [1] 3364 0
Country [1] 3364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5808 0
Royal Childrens Hospital
Ethics committee address [1] 5808 0
Ethics committee country [1] 5808 0
Australia
Date submitted for ethics approval [1] 5808 0
Approval date [1] 5808 0
31/10/2001
Ethics approval number [1] 5808 0
EHRC 20113A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28858 0
Address 28858 0
Country 28858 0
Phone 28858 0
Fax 28858 0
Email 28858 0
Contact person for public queries
Name 12015 0
catherine crock
Address 12015 0
Royal Childrens Hospital
Flemington Rd
Parkville Vic 3052
Country 12015 0
Australia
Phone 12015 0
61-3-93455522
Fax 12015 0
Email 12015 0
[email protected]
Contact person for scientific queries
Name 2943 0
catherine crock
Address 2943 0
Royal Childrens Hospital
Flemington Rd
Parkville Vic 3052
Country 2943 0
Australia
Phone 2943 0
61-3-93455522
Fax 2943 0
Email 2943 0
[email protected]

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.