Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000260022
Ethics application status
Approved
Date submitted
12/11/2009
Date registered
30/03/2010
Date last updated
30/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The sucrose study - A comparison of 24% versus 66% sugar to control procedural pain in new borns and young children
Scientific title
24% versus 66% sucrose to control procedural pain in neonates and young children- a randomized controlled trial
Secondary ID [1] 1556 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain response of young children during intra venous access device placement (iv access), phlebotomy or heel prick 252183 0
Condition category
Condition code
Anaesthesiology 252380 252380 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 ml of 66% oral sucrose as a single dose is offered to the infant prior to the procedure and if sucrose remains, throughout the procedure. The speed of giving the sucrose depends on the infants eagerness to suckle. Most infants are expected to suckle the whole amount of sucrose within 30-60 seconds.The procedure commences EXACTLY 2 minutes after the giving of sucrose commences.
Intervention code [1] 241541 0
Other interventions
Comparator / control treatment
1 ml of 24% oral sucrose as a single dose is offered to the infant prior to the procedure and if sucrose remains, throughout the procedure. The speed of giving the sucrose depends on the infants eagerness to suckle. Most infants are expected to suckle the whole amount of sucrose within 30-60 seconds.The procedure commences EXACTLY 2 minutes after the giving of sucrose commences.
Control group
Active

Outcomes
Primary outcome [1] 253254 0
Alder Hey Pain score difference of more than 1.3 points
Timepoint [1] 253254 0
Procedure commences 2 minutes after sucrose commenced, pain score is assessed continuos from begin until end of procedure. Maximum pain score at any stage during procedure is recorded. Expected time of procedure is expected to vary between 30 seconds (heel prick) to 5 minutes ( placement of intravenous access device)
Secondary outcome [1] 262237 0
Procedure successfull/unsuccessful is defined by achievement of initial intent:
'iv'- successful: placement of an intravenous access device( device in situ and patent)
'heel prick'-successful: obtained blood sample intended with one heel prick
'phlebotomy"- successful: obtained intended blood test with one phlebotomy attempt
Timepoint [1] 262237 0
after first attempt completed

Eligibility
Key inclusion criteria
parental consent, presenting to participating emergency departments, age 0-3 months , able to suckle / swallow, not critically ill.
Minimum age
0 Months
Maximum age
3 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
no consent , older than defined age, critically ill , unable to suckle, received sucrose in the previous 12 hours

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)
Numbered sealed sucrose samples are provided from pharmacy in identical, consecutive numbered packets containing each 1 ml of either 66 or 24% sucrose.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer randomisation in batches. The computer randomly allocates consecutive numbers to either group 'A' or group 'B'. These series of codes are given to pharmacy who replace 'A' and 'B' with 24% or 66% sucrose and prepare sucrose doses accordingly. The patients and all investigators are blinded to the sucrose concentration , pharmacy is blinded to the outcome.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2331 0
New Zealand
State/province [1] 2331 0

Funding & Sponsors
Funding source category [1] 244010 0
Hospital
Name [1] 244010 0
Mater children's hospital
Country [1] 244010 0
Australia
Primary sponsor type
Hospital
Name
Mater Children's Hospital
Address
Raymond Terrace
South Brisbane
Qld 4101
Country
Australia
Secondary sponsor category [1] 251361 0
Hospital
Name [1] 251361 0
Gold Coast Emergency Department
Address [1] 251361 0
Southport Nerang Street
Southport
Qld 4215
Country [1] 251361 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244114 0
Gold Coast Hospital Ethics committee
Ethics committee address [1] 244114 0
Office of human research ethics
Southport Nerang Street
Southport
Queensland 4215
Ethics committee country [1] 244114 0
Date submitted for ethics approval [1] 244114 0
Approval date [1] 244114 0
29/09/2009
Ethics approval number [1] 244114 0
HREC/09/QGC/34
Ethics committee name [2] 244115 0
Mater Children's Hospital
Ethics committee address [2] 244115 0
Raymond terrace
South Brisbane
Qld 4215
Ethics committee country [2] 244115 0
Date submitted for ethics approval [2] 244115 0
Approval date [2] 244115 0
25/09/2009
Ethics approval number [2] 244115 0
1393C

Summary
Brief summary
Children aged 0-3 month presenting to a participating emergency department and have been found to require medically indicated interventions ( placement of an intravenous access device, phlebotomy, heel prick) are enrolled after parental consent. After consent , patients will receive 1 ml of a study drug ( either 1 ml of 24% sucrose or 1ml of 66% sucrose). This is offered by a nurse to the infant who is encouraged to suckle on a pacifier or glove and is swaddled by a parent or caregiver at the same time. 2 minutes after the sucrose commenced, the procedure commences. During the procedure the attending nurse scores the maximum pain response as measured by Alder Hey pain score
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30502 0
Address 30502 0
Country 30502 0
Phone 30502 0
Fax 30502 0
Email 30502 0
Contact person for public queries
Name 13749 0
Dirken Christine Krahn
Address 13749 0
Gold Coast Emergency Department
Southport- Nerang Street
Southport
Queensland 4101
Country 13749 0
Australia
Phone 13749 0
+64 (0)210549044
Fax 13749 0
Email 13749 0
[email protected]
Contact person for scientific queries
Name 4677 0
David Herd
Address 4677 0
Mater Children's Emergency Department
Raymond terrace
South Brisbane
Qld 4215
Country 4677 0
Australia
Phone 4677 0
+61 7 31638100
Fax 4677 0
Email 4677 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.