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ShotBlocker During Intramuscular Injection Randomized Control Trial

NCT06624176 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Lauren Fortier

    lead OTHER

Principal Investigators

  • Lauren Fortier, CPNP, MSN · Pediatric Nurse Practitioner for the Department of Pediatrics & PICU

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
37 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-10
Primary Completion
2026-05-01
Completion
2026-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06624176 on ClinicalTrials.gov