RECRUITING Not applicable ClinicalTrials.gov

ShotBlocker During Intramuscular Injection Randomized Control Trial

Sponsor: Lauren Fortier • ClinicalTrials.gov ID: NCT06624176

Registry updated: 2026-10-20

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Description

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.

Interventions

Bionix ShotBlocker (Device)
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 (Other)
Standard of care swaddling
Sucrose administration (Other)
Standard of care sucrose administration
Masimo Rad-97 Oximeter probe (Other)
Oximeter probe

Eligibility criteria

Inclusion Criteria: * 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 * Have successfully attempted at least one oral feeding * No circumcision in the last 6 hours * Parental consent for Hepatitis B vaccine Exclusion Criteria: * 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 * Diagnosis of Neonatal Abstinence Syndrome (NAS) * Infants who are simultaneously receiving Hepatitis B Immunoglobulin or Nirsevimab (RSV vaccine) * Department of Children and Families (DCF) custody

Conditions

Neonatal Pain

Locations

UMass Memorial Medical Center- Memorial Campus — Worcester, Massachusetts, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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