Actively Recruiting
ShotBlocker During Intramuscular Injection Randomized Control Trial
Led by Lauren Fortier · Updated on 2026-01-08
200
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
ShotBlocker During Intramuscular Injection Randomized Control Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born at UMass Memorial Medical Center via vaginal or cesarean delivery and under nursery care
- Term infants between 37 and 42 weeks gestational age
- No acute illness causing pain
- Apgar score above 7 at 5 minutes
- Successfully attempted at least one oral feeding
- No circumcision in the last 6 hours
- Parental consent for Hepatitis B vaccine
You will not qualify if you...
- Swallow dysfunction
- Congenital or genetic abnormalities
- Exposure to sedatives within the last 12 hours
- Skin on thigh, hand, or foot not intact
- Diagnosis of Neonatal Abstinence Syndrome
- Receiving Hepatitis B Immunoglobulin or Nirsevimab simultaneously
- Under Department of Children and Families custody
AI-Screening
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Trial Site Locations
Total: 1 location
1
UMass Memorial Medical Center- Memorial Campus
Worcester, Massachusetts, United States, 01605
Actively Recruiting
Research Team
M
Madeline French, BS MBE
CONTACT
S
Samia Binta Rahman, MBBS MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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