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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
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
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

Study type
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

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
Timepoint [1] 3517 0
Immediately before,during cannulation and after cannulation.
Secondary outcome [2] 3518 0
Timepoint [2] 3518 0

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
Both males and females
Can healthy volunteers participate?
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
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
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 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 392 0
New Zealand
State/province [1] 392 0

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

Ethics approval
Ethics application status
Not yet submitted

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

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
Country 10550 0
New Zealand
Phone 10550 0
+64 21412732
Fax 10550 0
Email 10550 0
Contact person for scientific queries
Name 1478 0
David Herd
Address 1478 0
54 Woodside Ave
Country 1478 0
New Zealand
Phone 1478 0
+64 21412732
Fax 1478 0
Email 1478 0

No information has been provided regarding IPD availability
Summary results
No Results