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RecruitingNot ApplicableNCT06624176

ShotBlocker During Intramuscular Injection Randomized Control Trial

The Effect of ShotBlocker on Pain in Full Term Infants Undergoing Intramuscular Injection: A Randomized Controlled Trial

Sponsor

Lauren Fortier

Enrollment

200 participants

Start Date

Jan 10, 2024

Study Type

INTERVENTIONAL

Conditions

Neonatal Pain

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.

Eligibility

Min Age: 37 WeeksMax Age: 42 Weeks

Inclusion Criteria7

  • 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 Criteria7

  • 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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Interventions

DEVICEBionix 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.

OTHERSwaddling

Standard of care swaddling

OTHERSucrose administration

Standard of care sucrose administration

OTHERMasimo Rad-97 Oximeter probe

Oximeter probe

Locations(1)

UMass Memorial Medical Center- Memorial Campus

Worcester, Massachusetts, United States

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NCT06624176