Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000121561
Ethics application status
Approved
Date submitted
4/04/2006
Date registered
4/04/2006
Date last updated
4/04/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
EMLA versus N2O for analgesia during intravenous cannulation of children in the emergency department
Scientific title
A randomised clinical trial to compare the efficacy of Eutectic Mixture of Local Anaesthetics (EMLA) and nitrous oxide (N2O) in decreasing the pain of intravenous cannulation in children
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 1086 0
Condition category
Condition code
Anaesthesiology 1166 1166 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study participants were randomised to receive EMLA (administered to the skin as standard EMLA patches for a duration of 45 minutes).
Intervention code [1] 967 0
None
Comparator / control treatment
The study participants were randomised to receive nitrous oxide (administered as a 70%N2O/30%oxygen mixture via a face mask or mouthpiece for 3 minutes)
Control group
Active

Outcomes
Primary outcome [1] 1571 0
Child pain score
Timepoint [1] 1571 0
Measured immediatley after the cannulation
Secondary outcome [1] 2846 0
1. parental satisfaction score.
Timepoint [1] 2846 0
Measured immediately after cannulation of the child.
Secondary outcome [2] 2847 0
2. adverse event rates.
Timepoint [2] 2847 0
Measured immediately after cannulation of the child.

Eligibility
Key inclusion criteria
Required IV cannulation or venepuncture.
Minimum age
3 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
They were excluded if allergy to EMLA or nitrous oxide, suspected pneumothorax, bowel obstruction or other trapped gas, or if the parent/guardian are non-English speaking. Patients also need to be able to wait at least thirty minutes prior to cannulation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A note containing each individual patients allocation was sealed in an envelope inside each study pack
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1275 0
Hospital
Name [1] 1275 0
Northern Hospital (Victoria)
Country [1] 1275 0
Primary sponsor type
Hospital
Name
Northern Hospital, VIC
Address
Country
Australia
Secondary sponsor category [1] 1129 0
Hospital
Name [1] 1129 0
Austin Hospital, VIC
Address [1] 1129 0
Country [1] 1129 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2607 0
Northern Hospital
Ethics committee address [1] 2607 0
Ethics committee country [1] 2607 0
Australia
Date submitted for ethics approval [1] 2607 0
Approval date [1] 2607 0
24/05/2005
Ethics approval number [1] 2607 0
09/05

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

Contacts
Principal investigator
Name 35581 0
Address 35581 0
Country 35581 0
Phone 35581 0
Fax 35581 0
Email 35581 0
Contact person for public queries
Name 10156 0
Associate Professor David Taylor
Address 10156 0
Emergency Department
Austin Hospital
Studley Road
Heidelberg VIC 3084
Country 10156 0
Australia
Phone 10156 0
+61 3 94964883
Fax 10156 0
+61 3 94963380
Email 10156 0
David.Taylor@austin.org.au
Contact person for scientific queries
Name 1084 0
Dr Timothy Mann
Address 1084 0
Emergency Department
The Northern Hospital
195 Cooper Street
Epping VIC 3076
Country 1084 0
Australia
Phone 1084 0
+61 3 84058000
Fax 1084 0
+61 3 84058524
Email 1084 0
timmann@iprimus.com.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.