Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000069055
Ethics application status
Approved
Date submitted
11/01/2010
Date registered
20/01/2010
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of oral glucose for pain relief in 2 month old infants undergoing immunisation
Scientific title
A randomised controlled trial of oral glucose compared with water to relieve immunisation pain in 2 month old infants
Secondary ID [1] 1312 0
Nil
Universal Trial Number (UTN)
U1111-113-2199
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
immunisation pain in infants 256609 0
Condition category
Condition code
Public Health 256670 256670 0 0
Health promotion/education
Anaesthesiology 256775 256775 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 mls of 25% glucose administered orally immediately prior to immunisation injection
Intervention code [1] 255785 0
Treatment: Other
Comparator / control treatment
2mls sterile water administered orally immediately prior to immunisation injection
Control group
Placebo

Outcomes
Primary outcome [1] 257561 0
Pain scored using the Modified Behavioural Pain Scale (MBPS)
Timepoint [1] 257561 0
Procedure is videotaped to assess MBPS at three time periods
Time #1: Pre-Procedure (15 seconds)
Time #2: Intra-Procedure (10-20 secs)
Time #3: Post-Procedure (0-20) seconds after last injection
Filming continued for 2 minutes after procedure for assessment of secondary outcome
Secondary outcome [1] 262807 0
Crying duration
Timepoint [1] 262807 0
Procedure is videotaped to assess MBPS at three time periods
Time #1: Pre-Procedure (15 seconds)
Time #2: Intra-Procedure (10-20 secs)
Time #3: Post-Procedure (0-20) seconds after last injection
Filming continued for 2 minutes after procedure for assessment of crying time

Eligibility
Key inclusion criteria
Healthy full-term infants
Attending child health clinics in Irbid city in Jordan, for routine 2 month immunisation
Minimum age
7 Weeks
Maximum age
9 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Born Preterm (<34 completed weeks);
Experienced any prior surgery or illness (eg. circumcision);
Unwell for any reason eg fever >37.8C; complaining of any signs or symptoms of infectious disease (eg tonsillitis);
Have had a severe reaction to a prior immunisation;
Have had a severe reaction after eating eggs; Have had convulsions in the past or any other neurological disorders; have had or are having treatment for cancer; have had pain killers in the previous 24 hours; Have any illness which affects the immune system, Are taking any medicine that affects the immune system eg, immunosuppresants or high dose sterioids - these are all the National Immunisation Recommended eligibility criteria for infants undergoing immunisation in Jordan.

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)
Parents with infants attending clinic for routine 2 month immunisation are invited to participate-information given-eligibility checked - consent obtained for eligible infants.
Allocation: cpmputer based randomisation sequence developed prior to commencement of study by statistician. This produced a random sequence of intervention allocations linked with study idenficiation numbers running from 1-120. The study pharmacist prepared either 2mls of 25% glucose or sterile water in needle-less syringes according to the allocation sequence. As the solutions are both colourless and odourless and differences in viscosity are not apparent, the allocation sequence was blinded. Solution syringes were labelled with the study number only and were placed in a sequentially numbered envelope in the clinic. Infants received either solution according to the next sequentially numbered envelope with the number recorded in the study data file and the infant medical record. Treatment allocation remained unknown until all phases of data collection were completed, and data was entered into an SPSS file for analysis and analysis was completed. The final step in the analysis process required the statistician to reveal the allocation sequence
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence was prepared by Professor Madeleine King (study statistician) then emailed by her directly to Mohammad Graibeth (study Pharmacist in Alshif Irbid City Jordan).
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
Completed
Date of first participant enrolment
Anticipated
24/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 2392 0
Jordan
State/province [1] 2392 0
22110

Funding & Sponsors
Funding source category [1] 256269 0
Self funded/Unfunded
Name [1] 256269 0
Country [1] 256269 0
Primary sponsor type
University
Name
University of Technology Sydney
Address
Broadway, Ultimo, Sydney NSW 2007
Country
Australia
Secondary sponsor category [1] 251596 0
University
Name [1] 251596 0
Jordan University of Science and Technology (JUST)
Address [1] 251596 0
Irbid 22110
Jordan
Country [1] 251596 0
Jordan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258358 0
University of Technology Sydney
Ethics committee address [1] 258358 0
Ethics committee country [1] 258358 0
Australia
Date submitted for ethics approval [1] 258358 0
Approval date [1] 258358 0
29/03/2007
Ethics approval number [1] 258358 0
UTS HREC REF NO.2007-038A
Ethics committee name [2] 258359 0
Ministry of Health-Jordan Ethics Committee - Research Ethics Committee
Ethics committee address [2] 258359 0
Ethics committee country [2] 258359 0
Jordan
Date submitted for ethics approval [2] 258359 0
Approval date [2] 258359 0
03/07/2007
Ethics approval number [2] 258359 0
none provided

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

Contacts
Principal investigator
Name 30679 0
Address 30679 0
Country 30679 0
Phone 30679 0
Fax 30679 0
Email 30679 0
Contact person for public queries
Name 13926 0
Professor Maralyn Foureur
Address 13926 0
Centre for Midwifery Child and Family Health
University of Technology Sydney
Broadway, Ultimo, Sydney, NSW 2007
Country 13926 0
Australia
Phone 13926 0
+ 61 448448735
Fax 13926 0
Email 13926 0
[email protected]
Contact person for scientific queries
Name 4854 0
Maralyn Foureur
Address 4854 0
Centre for Midwifery Child and Family Health
University of Technology Sydney
Broadway, Ultimo, Sydney, NSW 2007
Country 4854 0
Australia
Phone 4854 0
+ 61 448448735
Fax 4854 0
Email 4854 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.