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A randomised controlled trial of oral glucose for pain relief in 2 month old infants undergoing immunisation

A randomised controlled trial of oral glucose compared with water to relieve immunisation pain in 2 month old infants

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000069055
Enrollment
120
Registered
2010-01-20
Start date
2007-05-24
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study focuses on the pain experienced by 2 month old infants when receiving their routine immunisations. We are testing whether a small amount of glucose solution administered onto the infant's tongue just prior to receiving the immunisation injection is able to decrease the amount of pain the infant experiences. We will compare the pain responses of infants receiving the glucose solution with those receiving water just prior to their immunisation injection.

Interventions

2 mls of 25% glucose administered orally immediately prior to immunisation injection

Sponsors

University of Technology Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
7 Weeks to 9 Weeks
Healthy volunteers
Yes

Inclusion criteria

Healthy full-term infants Attending child health clinics in Irbid city in Jordan, for routine 2 month immunisation

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026