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ShotBlocker During Intramuscular Injection Randomized Control Trial

Lauren Fortier · NCT06624176

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 8 mo–10 mo · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
200
US sites recruiting
1
Study start
January 10, 2024
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Bionix ShotBlocker; Swaddling; Sucrose administration; Masimo Rad-97 Oximeter probe

Conditions: Neonatal Pain

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • UMass Memorial Medical Center- Memorial Campus

    Worcester, MA 01605

    Site contact: Madeline E French, BS MBE · 5088870106 · madeline.french2@umassmed.edu

Study contacts (from the official record)

  • Madeline French, BS MBE · 5088870106 · madeline.french2@umassmed.edu
  • Samia Binta Rahman, MBBS MPH · 6034179792 · samiabinta.rahman6@umassmed.edu
All healthy volunteers studies in Massachusetts →
ShotBlocker During Intramuscular Injection Randomized Control Trial (NCT06624176) | Bored Studies