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Trial registered on ANZCTR


Registration number
ACTRN12609000796280
Ethics application status
Approved
Date submitted
2/02/2009
Date registered
15/09/2009
Date last updated
15/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain Ease spray vs. Angel cream for drip insertion in children
Scientific title
A comparison of a vapocoolant spray (Pain Ease) with Amethocaine Gel (AnGel) to reduce the pain associated with intravenous(IV) cannulation in children.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reduction of pain associated with IV cannulation in children 4260 0
Condition category
Condition code
Anaesthesiology 4484 4484 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this trial we would be applying a vapocoolant spray (PainEase) on the dorsum of the hands or cubital fossa of the children who would then undergo intravenous cannulation
The maximum number of times that this will be applied is four times and the least number of application would be once.The number of application of the product will be guided be successful intravenous cannulation and as stated the maximum number of application will be limited to four.
The mode of administration is that the prduct will be sprayed onto the skin of the dorsum of hand or the antecubital fossa(Topical).
The dosage will be that the spray will be applied for maximum of 10 seconds at the selected site during one attempt of intravenous cannulation.
The total duration of application at one site is 10 seconds and if cannulation is unsuccessful the next chosen site will be sprayed for maximum of 10 seconds.Overall the maximum total duration at four sites (if needed) will be 40 seconds.
Intervention code [1] 3984 0
Treatment: Drugs
Comparator / control treatment
The comparator treatment is Angel cream(4% amethocaine gel).
This product will be applied to four sites(both dorsum of hands and both antecubital fossa) and the site will be covered with transparent Opsite dressing for 45 minutes.
Thus this product will be applied once but to four different sites.
The mode of administration is topical at the four sites previously mentioned.
The dosage would be roughly the size of two dollar Australian coin at one site.
The total duration would be 45 minutes after which the opsite dressing will be removed and the product will be wiped off from the skin prior to cannulation attempt
Control group
Active

Outcomes
Primary outcome [1] 5364 0
Aim is to primarily evaluate the effectiveness of PainEase compared to AnGel in reducing the pain associated with IV cannulation
Timepoint [1] 5364 0
Pain score 1 min after successful IV cannulation(Child,doctor,nurse and parent).The child's face will be video recorded and two independent doctors will be assigning pain score using the same scale.These doctors will be unaware of the product applied to the child.
Secondary outcome [1] 9018 0
Evaluate the effect of use of AnGel or PainEase on cannulation success rate.
This outcome will be assessed based on the number of attempts needed for achieving suucessful intravenous cannulation when using either products which will be recorded on the study data collection sheet.
Timepoint [1] 9018 0
Number of IV cannulation attempts and time required to acheive successful IV cannulation
Secondary outcome [2] 257401 0
Difficulty in identifying vein after application of either product.
This will be assesed by the treating doctor using a 5 point scale (extremely easy to extremely difficult)
Timepoint [2] 257401 0
This assessment will be made just prior to cannulation
Secondary outcome [3] 257402 0
Adverse events secondary to application of either product.
This will be recorded by the treating doctor on the study data collection sheet and reviewed by local adverse event monitoring committee.
Timepoint [3] 257402 0
This will be assesed immidiately after application of product, before the child is discharged and follow up phone call 2 days after discharge.

Eligibility
Key inclusion criteria
Children between 6 and 18 yrs of age, presenting to the pediatric emergency department(PED) and requiring IV cannulation
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients requiring urgent vascular access
Patients with impaired consciousness, a history of psychiatric illness or with developmental delay
Use of opioid analgesics or sedating agents within 4 hours of enrollment
Patients with pain score of greater than 6 (Pain Scale 0-10), i.e. requiring urgent analgesia
In patients with Diabetes Mellitus or patients with Cold hypersensitivity as Pain Ease is specifically contraindicated in these groups.
Sensitivity or previous adverse reactions to halogenated hydrocarbons or amethocaine
Non English speaking families
Those unable to understand the study protocol or the Visual Analog scale

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)
All children aged 6-18 years needing IV cannulation will be approached to take part in the study.Randomisation will be done using a computer generated random number table.Allocation will be done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The child's face will be video recorded during IV cannulation.This video will be reviewed by two independent person who will each provide a pain score.These pain score will be compared to the scores given by the child, parent,nurse and doctor.This will help improve the validity of the pain score.
Safety/efficacy
Prospective
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4439 0
Self funded/Unfunded
Name [1] 4439 0
Dr Benjamin D'Souza
Country [1] 4439 0
Australia
Primary sponsor type
Individual
Name
Dr Benjamin D'Souza
Address
Children youth and women's health service
72 King William Road
Adelaide
SA-5006
Country
Australia
Secondary sponsor category [1] 4000 0
Hospital
Name [1] 4000 0
Women's and Childrens Hospital
Address [1] 4000 0
72 King William Road
Adelaide
SA-5006
Country [1] 4000 0
Australia
Secondary sponsor category [2] 237096 0
None
Name [2] 237096 0
Address [2] 237096 0
Country [2] 237096 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6493 0
Human Research Ethics Committee(HREC)
Ethics committee address [1] 6493 0
Ethics committee country [1] 6493 0
Australia
Date submitted for ethics approval [1] 6493 0
Approval date [1] 6493 0
16/01/2009
Ethics approval number [1] 6493 0
2611

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

Contacts
Principal investigator
Name 29240 0
Address 29240 0
Country 29240 0
Phone 29240 0
Fax 29240 0
Email 29240 0
Contact person for public queries
Name 12487 0
Dr Benjamin D'Souza
Address 12487 0
72 King William Road
Adelaide
SA 5006
Country 12487 0
Australia
Phone 12487 0
+61 8 81617000
Fax 12487 0
Email 12487 0
Benjamin.D'Souza@cywhs.sa.gov.au
Contact person for scientific queries
Name 3415 0
Dr Benjamin D'Souza
Address 3415 0
72 King William Road
Adelaide
SA 5006
Country 3415 0
Australia
Phone 3415 0
+61 8 81617000
Fax 3415 0
Email 3415 0
Benjamin.D'Souza@cywhs.sa.gov.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.