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Trial registered on ANZCTR


Registration number
ACTRN12614000784617
Ethics application status
Approved
Date submitted
1/07/2014
Date registered
23/07/2014
Date last updated
6/11/2018
Date data sharing statement initially provided
6/11/2018
Date results information initially provided
6/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pain Management for Older Infants During Immunisation: A pilot randomised, controlled trial
(The MINDI Trial Pilot Study)
Scientific title
Pain management (sucrose 25% and distraction versus sucrose 75% and distraction versus sterile water and distraction) during routine 12 monthly immunisation.
Secondary ID [1] 284899 0
None
Universal Trial Number (UTN)
Trial acronym
MINDI Trial Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute pain 292359 0
Pain management 292360 0
Condition category
Condition code
Public Health 292682 292682 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sucrose 25% and distraction (Group 2):
2 mls will be administered slowly over 15 to 30 seconds orally via a needle-less syringe immediately prior to the infant’s immunisation injections. The infants will receive the combined Haemophilus influenzae type B/Meningococcal C vaccine (Hib-MenCCV) as an intramuscular injection, and the measles, mumps and rubella (MMR) as a subcutaneous injection (2 separate injections, one in each upper arm) by the Immunisation Nurse. The technique for administration of the injections by the immunisation nurses will be in accordance with the recommendations as outlined in the Australian Immunisation Handbook. The injection, immunisation procedure, injection sites and order of each injection will be consistent for all infants across the study settings. A battery-operated bubble maker with colourful flashing lights will be used by the researcher to distract the infants immediately following the administration of the oral solution, and will continue until completion of the last injection. All infants will be placed in the ‘cuddle’ position for the injections whereby the child sits sideways on the lap of the parent/guardian, with the arm to be injected held close to the child’s body while the other arm is tucked under the armpit and behind the back of the parent/guardian who secures the infant’s exposed arm at the elbow as outlined in the Australian Immunisation Handbook.The volume of the sucrose (2 millilitres) used in this study is consistent with previous studies in this age group, and minimises the amount of sucrose administered.

Sucrose 65% and distraction (Group 2):
2 mls will be administered slowly over 15 to 30 seconds orally via a needle-less syringe immediately prior to the infant’s immunisation injections. The infants will receive the combined Haemophilus influenzae type B/Meningococcal C vaccine (Hib-MenCCV) as an intramuscular injection, and the measles, mumps and rubella (MMR) as a subcutaneous injection (2 separate injections, one in each upper arm) by the Immunisation Nurse. The technique for administration of the injections by the immunisation nurses will be in accordance with the recommendations as outlined in the Australian Immunisation Handbook. The injection, immunisation procedure, injection sites and order of each injection will be consistent for all infants. A battery-operated bubble maker with colourful flashing lights will be used by the researcher to distract the infants immediately following the administration of the oral solution, and will continue until completion of the last injection.
The volume of the sucrose (2 millilitres) used in this study is consistent with previous studies in this age group, and minimises the amount of sucrose administered. All infants will be placed in the ‘cuddle’ position for the injections whereby the child sits sideways on the lap of the parent/guardian, with the arm to be injected held close to the child’s body while the other arm is tucked under the armpit and behind the back of the parent/guardian who secures the infant’s exposed arm at the elbow as outlined in the Australian Immunisation Handbook.

Intervention code [1] 289717 0
Treatment: Other
Comparator / control treatment
Placebo and distraction (Group 3) –A 2 ml dose of sterile water will be administered slowly over 15 to 30 seconds orally via a needle-less syringe immediately prior to the infant’s immunisation injections. The infants will receive the combined Haemophilus influenzae type B/Meningococcal C vaccine (Hib-MenCCV) as an intramuscular injection, and the measles, mumps and rubella (MMR) as a subcutaneous injection (2 separate injections, one in each upper arm) by the Immunisation Nurse. The technique for administration of the injections by the immunisation nurses will be in accordance with the recommendations as outlined in the Australian Immunisation Handbook. The injection, immunisation procedure, injection sites and order of each injection will be consistent for all infants across the study settings. A battery-operated bubble maker with colourful flashing lights will be used by the researcher to distract the infants immediately following the administration of the oral solution, and will continue until completion of the last injection.
All infants will be placed in the ‘cuddle’ position for the injections whereby the child sits sideways on the lap of the parent/guardian, with the arm to be injected held close to the child’s body while the other arm is tucked under the armpit and behind the back of the parent/guardian who secures the infant’s exposed arm at the elbow as outlined in the Australian Immunisation Handbook.
Control group
Placebo

Outcomes
Primary outcome [1] 292526 0
Infant pain:
Pain will be measured using the validated Modified Behavioural Pain Scale (MBPS).
Timepoint [1] 292526 0
Baseline, during the first, and during the second injection, and 2 minutes post second (final) injection
Secondary outcome [1] 309149 0
Total duration of crying time:
Crying will be defined as the presence of audible negative vocalisations in combination with facial grimacing.
Timepoint [1] 309149 0
Crying time will be measured from the insertion of the first needle to cessation of crying or up to 3 minutes after the second (last injection), and whichever occurs first.
Secondary outcome [2] 309151 0
Incidence of crying (yes/no)
Timepoint [2] 309151 0
During immunisation
Secondary outcome [3] 309152 0
Parental/guardian perception of infant pain using the Visual Analogue Scale (VAS).
Timepoint [3] 309152 0
Within 3 minutes after the 2nd (final) injection.

Eligibility
Key inclusion criteria
Healthy infants attending the immunisation clinics for the scheduled 12-month immunisations will be recruited.
Minimum age
12 Months
Maximum age
12 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The following infants will be excluded from participating in the study:
Breastfeeding infants whose parents choose to breastfeed during immunisation;
Infants who have received an analgesic in the previous 24 hours including paracetamol, so as to not affect the response to painful stimuli during the procedure;
Infants who cannot receive their immunisation due to the presence of immunisation risk factors as cited in the Australian Immunisation Handbook (and as determined by the Immunisation Nurses);
Infants who are not able to be administered a sugar solution (as reported by the parents), and
Non-English speaking parents/guardians that do not have access to English translation at the time of the enrolment.

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)
A research nurse familiar with the immunisation clinics will be present at the clinic to approach parents attending the clinic. If an infant is eligible, the research nurse will explain the study, determine the parent’s/guardian’s interest in participation, and obtain informed consent. Following parental consent to participate in the study, the researcher will record brief demographical data (e.g. number of other children, infant’s general health status) that will be provided by the parent/guardian.
The study pharmacist will prepare either 2 millilitres of 25% sucrose, 65% sucrose, or sterile water in capped needle-less syringes according to the allocation sequence. Solution syringes will be labelled with the study number only, and will be placed in an opaque sealed and numbered envelope and opened sequentially for each participating infant. A placebo (sterile water) in addition to distraction (control group) is used to maintain blinding of the interventions to the researchers, nurses and parents, and avoid performance and detection bias. Study solutions will be prepared on a monthly basis in identical syringes. As all the solutions are colourless and odourless and differences in viscosity will not be apparent, and the allocation sequence will be blinded. Infants will receive one of the three solutions according to the next sequentially numbered envelope with the number recorded in the study data file and the infant’s record. Treatment allocation will remain unknown to the investigators until completion of the trial and completion of summary statistics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer generated.
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
Statistical analysis will be on an intention to treat (ITT) basis. The primary and secondary endpoints will be analysed using ANOVA comparisons. The primary and secondary endpoint analysis will use a between-group ANOVA to determine if there is a significant effect for each study endpoint. Demographic information will be presented in tables and descriptive statistics, such as the mean and standard deviation, will be used to summarise participants’ data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289521 0
University
Name [1] 289521 0
University of Western Sydney
Address [1] 289521 0
Locked Bag 1797, Penrith NSW 2751
Country [1] 289521 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
School of Nursing and Midwifery
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 288210 0
None
Name [1] 288210 0
Address [1] 288210 0
Country [1] 288210 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291266 0
University of Western Sydney
Ethics committee address [1] 291266 0
Locked Bag 1797, Penrith NSW 2751
Ethics committee country [1] 291266 0
Australia
Date submitted for ethics approval [1] 291266 0
Approval date [1] 291266 0
11/06/2014
Ethics approval number [1] 291266 0
H10671

Summary
Brief summary
Immunisation is regarded as one of the most significant preventive health measures of all time. Since the implementation of immunisation programs worldwide, there has been a substantial reduction in both morbidity and mortality caused by infectious diseases. Most vaccines, however, require a needle puncture and infants receive up to 14 separate injections within the first 18 months of life. Up to four separate injections may be required on the one
occasion in high risk infants. Sucrose 25% is now a widely used strategy for the management of needle related pain in Australian neonatal intensive care units, special care nurseries and postnatal units in newborn infants. However, the results from a recent Cochrane systematic review concluded that there is a lack of evidence to recommend sucrose for the management of needle-related pain in older infants. The authors recommended that further research is
required to determine the effectiveness of sucrose, and also determine the most effective concentration in older, larger infants beyond the newborn period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49598 0
Dr Jann Foster
Address 49598 0
School of Nursing and Midwifery
University of Western Sydney
Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country 49598 0
Australia
Phone 49598 0
+61 2 4620 3667
Fax 49598 0
Email 49598 0
j.foster@uws.edu.au
Contact person for public queries
Name 49599 0
Dr Jann Foster
Address 49599 0
School of Nursing and Midwifery
University of Western Sydney
Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country 49599 0
Australia
Phone 49599 0
+61 2 4620 3667
Fax 49599 0
Email 49599 0
j.foster@uws.edu.au
Contact person for scientific queries
Name 49600 0
Dr Jann Foster
Address 49600 0
School of Nursing and Midwifery
University of Western Sydney
Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country 49600 0
Australia
Phone 49600 0
+61 2 4620 3667
Fax 49600 0
Email 49600 0
j.foster@uws.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary