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Trial registered on ANZCTR


Registration number
ACTRN12610000355077
Ethics application status
Approved
Date submitted
27/04/2010
Date registered
4/05/2010
Date last updated
10/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Sucrose analgesia during needle related procedures in infants and young children
Scientific title
Does sucrose solution for infants, and lollypops for pre-school children 3-5 years of age, reduce pain during scheduled childhood immunisation in healthy children, and venepuncture in hospitalized children, compared to placebo (infants) and distraction (pre-school children).
Secondary ID [1] 251669 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Needle related pain and distress in young children 257251 0
Condition category
Condition code
Public Health 257391 257391 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immunisation Study: Infants: 2mL of 33% oral sucrose solution, given in 0.25 - 0.5mL alliquots; commencing 2 minutes prior to first injection (0.5mL), and repeating immediately prior to each injection (0.25mL).
Pre-school children: Glucose lollypop (~8 grams glucose/lollypop) commencing sucking 2 minutes during prior to first immunisation, and continuing prior to each subsequent immunisation. Immunisations: 12 months: 3 injections Haemophilus influenzae type B (Hib: Hiberix) Measles, Mumps, Rubella (MMR: Priorix) Meningococcal C (NeisVacC) 18 months: 1 injection Varicella (Varilrix) 3-5 Years: 2 injections Diptheria, Tetanus, Pertussis, Inactivated Polio vaccine (Infanrix-IPV) MMR (Priorix)
Venepuncture Study: Hospitalized todders aged 12 - 36 months requiring venepuncture will receive 2mL of 24% oral sucrose solution, given in 0.25 alliquots; commencing 2 minutes prior to needle insertion; repeating immediately prior to needle insertion, and given 2 minutely until completion of procedure.
Intervention code [1] 256372 0
Treatment: Other
Comparator / control treatment
Immunisation Study:
Infants: Water during immunisation
Pre-school children: Distraction, by coaching children to blow on pin wheels, during immunisation, with lollypop given following immunisation
Venepuncture Study: Water during immunisation or venepuncture
Control group
Placebo

Outcomes
Primary outcome [1] 258315 0
Cry duration as assessed by coders blinded to purpose of study, viewing video analysis of procedures, and timing cry duration using stop watch.
Timepoint [1] 258315 0
Throughout immunisation and venepuncture
Primary outcome [2] 258316 0
Pain score; FLACC (Face, Legs, Arms, Crying, Consolability)
Timepoint [2] 258316 0
Immunisation study: Upon first injection and 15 & 30 seconds following completion of each injection.
Venepuncture: 7 phases prior to commencement, throughout procedure and following completion of procedure:
1. Baseline; prior to administration of the study solutions
2. Immediately following first dose of the study solution
3. Upon commencement of the needle insertion
4. 30 seconds during the procedure
5. 60 seconds during the procedure
6. Upon completion of the procedure
7. 60 seconds following completion of the procedure
Primary outcome [3] 258317 0
Parent Visual Analogue Scale (VAS ) on a 0-10 scale.
Timepoint [3] 258317 0
Upon completion of needle procedures
Secondary outcome [1] 264022 0
Children's Compliance with intervention : (0-3 scale: Fully compliant, Somewhat compliant, Not compliant
Timepoint [1] 264022 0
Upon completion of needle procedures
Secondary outcome [2] 264039 0
Pre-school children only: Self report of pain using Wong-Baker Pain scale
Timepoint [2] 264039 0
Upon completion of immunisation procedure

Eligibility
Key inclusion criteria
Site 1: Infants/toddlers aged 12-18 months and pre-school children aged 3-5 years, undergoing scheduled childhood immunisation in the Royal Children’s Hospital Immunisation Centre.

Site 2: Toddlers aged 12-36 months undergoing venepuncture in the Children's Hospital of Eastern Ontario surgical unit.
Minimum age
1 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Insufficient understanding of English If already eating/drinking sweet solutions or foods
In addition for venepuncture study: If received muscle relaxants or opioid analgesics within preceeding 24 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)
Site 1:
Participants to be randomised in advance to receive sucrose or water (Infants/toddlers) or lollypop or distraction prior to and during the immunisation procedure by computer random number generator prepared by the Royal Children’s Hospital Clinical Epidemiology and Biostatistics Unit (CEBU). For infants/toddlers; study solutions to be prepared on a monthly basis in identical three mL syringes, as per the randomisation code and numbered sequentially. For pre-school children, allocation code to be placed in opaque sealed envelope to be opened sequentially for each participating child.

Site 2: Participants to be randomised in advance to receive sucrose or water prior to and during the venepuncture procedure by computer random number generator prepared by the Children's Hospital of Eastern Ontario, Canada, Clinical Research Unit. Study solutions to be prepared on a monthly basis in identical three mL syringes, as per the randomisation code and numbered sequentially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generator
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
As above for infant group only. Masking/blinding for pe-school children cannot occur, although coders will be blinded to the purpose of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2011
Actual
7/02/2011
Date of last participant enrolment
Anticipated
Actual
10/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3427 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 9193 0
3051 - North Melbourne
Recruitment outside Australia
Country [1] 6645 0
Canada
State/province [1] 6645 0
Ontario

Funding & Sponsors
Funding source category [1] 256881 0
Hospital
Name [1] 256881 0
Nurses Board of Victoria
Country [1] 256881 0
Australia
Funding source category [2] 290715 0
Hospital
Name [2] 290715 0
Children's Hospital of Eastern Ontario Research Institute
Country [2] 290715 0
Canada
Primary sponsor type
Individual
Name
Denise Harrison
Address
Neonatal Unit, Royal Children's Hospital, Flemington Road, Parkville, 3052. Victoria, Australia
Country
Australia
Secondary sponsor category [1] 256153 0
None
Name [1] 256153 0
Address [1] 256153 0
Country [1] 256153 0
Other collaborator category [1] 1221 0
Hospital
Name [1] 1221 0
Royal Children's Hospital Melbourne for immunisation study.
CHEO for venepuncture study
Address [1] 1221 0
Site 1: Flemington Road, Parkville, Victoria, 3052
Site 2: 401 Smyth Rd. Ottawa, ON K1H 8L1
Country [1] 1221 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258887 0
Royal Children's Hospital
Ethics committee address [1] 258887 0
Ethics committee country [1] 258887 0
Australia
Date submitted for ethics approval [1] 258887 0
Approval date [1] 258887 0
04/10/2010
Ethics approval number [1] 258887 0
30101 A
Ethics committee name [2] 260392 0
CHEO Research Ethics Board
Ethics committee address [2] 260392 0
Ethics committee country [2] 260392 0
Canada
Date submitted for ethics approval [2] 260392 0
01/06/2011
Approval date [2] 260392 0
28/10/2011
Ethics approval number [2] 260392 0
11/20E

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

Contacts
Principal investigator
Name 31102 0
Dr Denise Harrison
Address 31102 0
Children's Hospital of Eastern Ontario (CHEO) and Faculty of Health Sciences, University of Ottawa 401 Smyth Rd. Ottawa, ON K1H 8L1
Country 31102 0
Canada
Phone 31102 0
+1 613-562-5800, ext 8693
Fax 31102 0
Email 31102 0
dharrison@cheo.on.ca
Contact person for public queries
Name 14349 0
Denise Harrison
Address 14349 0
Children's Hospital of Eastern Ontario (CHEO) and Faculty of Health Sciences, University of Ottawa 401 Smyth Rd. Ottawa, ON K1H 8L1
Country 14349 0
Canada
Phone 14349 0
+1 613-562-5800, ext 8693
Fax 14349 0
Email 14349 0
deniseh@unimelb.edu.au OR dharrison@cheo.on.ca
Contact person for scientific queries
Name 5277 0
Denise Harrison
Address 5277 0
Children's Hospital of Eastern Ontario (CHEO) and Faculty of Health Sciences, University of Ottawa

401 Smyth Rd. Ottawa, ON K1H 8L1

Tel: +1 613-562-5800, ext 8693
Country 5277 0
Canada
Phone 5277 0
+1 613-562-5800, ext 8693
Fax 5277 0
Email 5277 0
dharrison@cheo.on.ca

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
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Documents added automatically
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