About this 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.
Eligibility criteria
Qualifiers
Infants born at UMass Memorial Medical Center (UMMMC) via vaginal delivery or cesarean delivery and under the care of the nursery team
Term infants (37 to 42 weeks gestational age)
No acute illness that causes pain
Apgar score above 7 at 5 minutes
Disqualifiers
Swallow dysfunction
Congenital or genetic abnormalities
Infants who were exposed to sedatives within the last 12 hours
Infants with skin on thigh, hand, or foot that is not intact
Trial design
Treatments tested in this trial
- Bionix ShotBlocker
- Swaddling
- Sucrose administration
- Masimo Rad-97 Oximeter probe
Treatment groups
Sponsors and collaborators
Lauren Fortier
Lead sponsor
University of Massachusetts, Worcester
Sponsor institution