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The Effect of ShotBlocker on Pain in Full Term Infants Undergoing Intramuscular Injection: A Randomized Controlled Trial
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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
Yes
UMass Memorial Medical Center- Memorial Campus
Worcester, Massachusetts, United States
Start Date
January 10, 2024
Primary Completion Date
May 1, 2026
Completion Date
August 1, 2026
Last Updated
January 8, 2026
200
ESTIMATED participants
Bionix ShotBlocker
DEVICE
Swaddling
OTHER
Sucrose administration
OTHER
Masimo Rad-97 Oximeter probe
OTHER
Lead Sponsor
Lauren Fortier
Data Source & Attribution
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