None listed
Conditions
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.
Interventions
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 o
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.
Sponsors
University of Western Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
12 Months to 12 Months
Healthy volunteers
Yes
Inclusion criteria
Healthy infants attending the immunisation clinics for the scheduled 12-month immunisations will be recruited.
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.
Outcome results
None listed