Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000409572
Ethics application status
Not yet submitted
Date submitted
17/09/2006
Date registered
19/09/2006
Date last updated
4/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical Amethocaine versus Topical Eutectic Mixture of Local Anaesthetic (EMLA)
Scientific title
In Children's Emergency does topical Amethocaine 4% increase cannulation success compared to Topical Eutectic Mixture of Local Anaesthetic (EMLA) 5%?
Secondary ID [1] 305 0
Auckland District Health Board: A+3584
Universal Trial Number (UTN)
Trial acronym
TAVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intravenous cannulation in children 1376 0
Condition category
Condition code
Anaesthesiology 1469 1469 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is Amethocaine, in a single dose of 1-2g in two places. The two sites are typically on the dorsum of both hands, but may include other sites depending on the triage nurses judgement. Study runs from November 2006 until March 2007.
Intervention code [1] 1361 0
Treatment: Drugs
Comparator / control treatment
Control group is EMLA (our current topical anaesthetic), in a single dose of 1-2g in two places.
Control group
Active

Outcomes
Primary outcome [1] 2032 0
First attempt cannulation success while in the treatment room. Cannula that are successfully inserted but fall out after the child has left the room are counted as successful cannulation.
Timepoint [1] 2032 0
Secondary outcome [1] 3517 0
Pain
Timepoint [1] 3517 0
Immediately before,during cannulation and after cannulation.
Secondary outcome [2] 3518 0
Cost
Timepoint [2] 3518 0

Eligibility
Key inclusion criteria
All children having topical anaesthetic applied for intravenous cannulation in our department are eligible.
Minimum age
Not stated
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those needing emergency IV access or contraindications to topical anaesthetic (currently <3 months of age or on met-Haemaglobinaemia inducing medicines).

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)
Opaque sealed envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated then randomly sorted envelops
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Child, parents, assessor and data analyst blinded. The nurse applying the cream will be aware of allocation. It may not be possible to fully blind the dermal effects of the creams as the creams have different effects (one blanches the other causes erythema).
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
660
Accrual to date
Final
Recruitment outside Australia
Country [1] 392 0
New Zealand
State/province [1] 392 0

Funding & Sponsors
Funding source category [1] 1607 0
University
Name [1] 1607 0
Auckland University
Country [1] 1607 0
New Zealand
Funding source category [2] 1608 0
Charities/Societies/Foundations
Name [2] 1608 0
Auckland Medical Research Foundation
Country [2] 1608 0
New Zealand
Primary sponsor type
Government body
Name
Auckland District Health Board
Address
Country
New Zealand
Secondary sponsor category [1] 1411 0
University
Name [1] 1411 0
University of Auckland
Address [1] 1411 0
Country [1] 1411 0
Australia

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
Children's distress and pain from intravenous cannulation is reduced with the use of topical anaesthetic cream. At Starship children’s emergency department (CED) we use EMLA (Eutectic Mixture of Local Anaesthetic) and are very satisfied with its effect. A recent Cochrane systematic review suggests that Amethocaine is a better topical anaesthetic (1). Amethocaine works faster and has better pain relieving abilities than EMLA independent of application time. There is even a suggestion that Amethocaine may improve success rates for IV access although the evidence was inconclusive. EMLA is a vasoconstrictor, which appears to constrict veins whereas Amethocaine is a vasodilator and causes local erythema. Amethocaine has traditionally been more expensive than EMLA. The Cochrane review found two clinical questions unanswered; does Amethocaine improve cannulation success rate and what are the cost implications? This research project will attempt to answer these questions by comparing the use of EMLA and Amethocaine for topical anaesthesia in children undergoing intravenous cannulation at Starship CED.

1. Lander JA, Weltman BJ and So SS. EMLA and Amethocaine for reduction of children’s pain associated with needle insertion (Review). Cochrane Database of Systematic Reviews. (3). 2006.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27588 0
Address 27588 0
Country 27588 0
Phone 27588 0
Fax 27588 0
Email 27588 0
Contact person for public queries
Name 10550 0
David Herd
Address 10550 0
54 Woodside Ave
Northcote
Auckland
Country 10550 0
New Zealand
Phone 10550 0
+64 21412732
Fax 10550 0
Email 10550 0
[email protected]
Contact person for scientific queries
Name 1478 0
David Herd
Address 1478 0
54 Woodside Ave
Northcote
Auckland
Country 1478 0
New Zealand
Phone 1478 0
+64 21412732
Fax 1478 0
Email 1478 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.