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ShotBlocker During Intramuscular Injection Randomized Control Trial

RecruitingNAAges 37 Weeks - 42 WeeksAllLauren Fortier
NCT06624176 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Bionix ShotBlocker
  • Swaddling
  • Sucrose administration
  • Masimo Rad-97 Oximeter probe
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Where

1 site
UMass Memorial Medical Center- Memorial Campus
Worcester, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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