NCT06624176

ShotBlocker During Intramuscular Injection Randomized Control Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Lauren Fortier · Academic / Other
• Sex: All
• Age: 37 Weeks – 42 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Neonatal Pain

Interventions

Type	Name	Description
DEVICE	Bionix 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.
OTHER	Swaddling	Standard of care swaddling
OTHER	Sucrose administration	Standard of care sucrose administration
OTHER	Masimo Rad-97 Oximeter probe	Oximeter probe

Timeline

• Start date: 2024-01-10
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2024-10-02
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study