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ShotBlocker During Intramuscular Injection Randomized Control Trial
Sponsor: Lauren Fortier
Summary
The objective of this trial is to evaluate the effect of Bionix ShotBlocker on pain of injection of the first Hepatitis B vaccine in healthy newborns. ShotBlocker is a pain reducing tool used in babies, children, and adults for injections. Swaddling during the injection and administration of oral sucrose prior to the injection are established standards of care for painful procedures in neonates. The investigators hypothesize that the use of ShotBlocker in addition to swaddling and oral sucrose administration will lessen the pain response.
Official title: The Effect of ShotBlocker on Pain in Full Term Infants Undergoing Intramuscular Injection: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
37 Weeks - 42 Weeks
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-01-10
Completion Date
2026-08-01
Last Updated
2026-01-08
Healthy Volunteers
Yes
Conditions
Interventions
Bionix ShotBlocker
This is a hospital-approved device used as standard-of-care in older children and adults to reduce pain during painful procedures. It is not considered established standard-of-care in the infant cohort.
Swaddling
Standard of care swaddling
Sucrose administration
Standard of care sucrose administration
Masimo Rad-97 Oximeter probe
Oximeter probe
Locations (1)
UMass Memorial Medical Center- Memorial Campus
Worcester, Massachusetts, United States