Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000194662
Ethics application status
Approved
Date submitted
8/07/2007
Date registered
24/02/2014
Date last updated
24/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oral sucrose for pain relief in children undergoing bladder catheterization.
Scientific title
In children undergoing bladder catheterization, does oral sucrose compared to placebo, reduce pain and distress caused by the procedure?
Secondary ID [1] 284128 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain experienced during bladder catheterization. 2176 0
Condition category
Condition code
Renal and Urogenital 2271 2271 0 0
Other renal and urogenital disorders
Anaesthesiology 291568 291568 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention - 4 mLs of 75% sucrose administered orally once only prior to bladder catheterisation. Participants are reviewed immediately following the procedure.
Intervention code [1] 1879 0
Treatment: Other
Comparator / control treatment
Placebo - 4mL of water administered orally
Control group
Placebo

Outcomes
Primary outcome [1] 3134 0
Crying time
Timepoint [1] 3134 0
Duration of first cry, total sum of crying time and total duration of crying immediately following bladder catheterization.
Primary outcome [2] 3135 0
Heart rate measured by pulse oximetry.
Timepoint [2] 3135 0
Difference in heart rate before (5 min prior to catheter) and after bladder catheterisation (1 min immediately after catheter).
Primary outcome [3] 3136 0
FLACC and OUCHER pain scales
Timepoint [3] 3136 0
Immediately before, during and immediately after bladder catheterisation.
Secondary outcome [1] 5269 0
Nil.
Timepoint [1] 5269 0
Nil

Eligibility
Key inclusion criteria
Infants or children requiring bladder catheterisation for diagnosis of suspected urinary tract infection.
Have not achieved bladder control.
Minimum age
3 Months
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to tolerate oral fluids. Unsuccessful first attempt at bladder catheterisation. Toilet trained. Oral sucrose is contraindicated (eg diabetic ketoacidosis). Altered neurological state (eg moribund, neurological conditions).

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)
Once a patient is identified as potentially eligible for the study, a co-investigator is contacted who confirms eligibility. Allocation occurs by numbered envelopes containing pre-filled syringes of either sucrose (active treatment) or water (placebo). Both sucrose and water are clear, colourless solutions and are unable to be differentiated by their appearance. The co-investigator is blinded to the order of the treatment/placebo allocation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization by computerized random number generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2006
Actual
9/06/2006
Date of last participant enrolment
Anticipated
Actual
18/06/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2116 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 7808 0
2750 - Penrith

Funding & Sponsors
Funding source category [1] 2435 0
Hospital
Name [1] 2435 0
Nepean Hospital Paediatric Department
Country [1] 2435 0
Australia
Primary sponsor type
Individual
Name
Ralph Nanan
Address
Level 5, South Block
Nepean Hospital
Derby St
Penrith NSW, 2750
Country
Australia
Secondary sponsor category [1] 2207 0
None
Name [1] 2207 0
Nil.
Address [1] 2207 0
Nil
Country [1] 2207 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4287 0
Nepean Hospital Human Research Ethics Committee
Ethics committee address [1] 4287 0
Ethics Office
Nepean Hospital
Derby St
Penrith NSW, 2750
Ethics committee country [1] 4287 0
Australia
Date submitted for ethics approval [1] 4287 0
Approval date [1] 4287 0
Ethics approval number [1] 4287 0

Summary
Brief summary
This study is to determine if oral sucrose is useful at reducing the pain and distress caused by bladder catheterisation in children. This is a common and important procedure, often required to diagnose urine infections in children, and currently there is no effective, practical methods proven to reduce the pain caused by this procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27693 0
Prof Ralph Nanan
Address 27693 0
Level 5, South Block
Nepean Hospital
Derby St
Penrith NSW, 2750
Country 27693 0
Australia
Phone 27693 0
61247343363
Fax 27693 0
Email 27693 0
[email protected]
Contact person for public queries
Name 11068 0
Dr Anthony Liu
Address 11068 0
Paediatric Department
Level 5
South Block
Nepean Hospital
Derby St
Penrith NSW 2750
Country 11068 0
Australia
Phone 11068 0
61247343363
Fax 11068 0
Email 11068 0
[email protected]
Contact person for scientific queries
Name 1996 0
Dr Anthony Liu
Address 1996 0
Paediatric Department
Level 5
South Block
Nepean Hospital
Derby St
Penrith NSW 2750
Country 1996 0
Australia
Phone 1996 0
61247343363
Fax 1996 0
Email 1996 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
SourceTitleYear of PublicationDOI
EmbaseOral sucrose for analgesia in children aged between 3 months and 3 years undergoing transurethral bladder catheterisation: A randomised, double-blinded, clinical trial.2020https://dx.doi.org/10.1111/jpc.14559
N.B. These documents automatically identified may not have been verified by the study sponsor.