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ShotBlocker During Intramuscular Injection Randomized Control Trial

NCT06624176

This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Neonatal Pain

Eligibility basics and study details

Study type
Interventional
Phase
Not applicable
Ages
37 to 42 weeks
Sex
All
Healthy volunteers
Accepted
Sponsor
Lauren Fortier
Last updated on ClinicalTrials.gov
June 4, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Massachusetts · 1

  • UMass Memorial Medical Center- Memorial Campus · Worcester, MA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.