RecruitingNot ApplicableNCT06624176

ShotBlocker During Intramuscular Injection Randomized Control Trial

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


Sponsor

Lauren Fortier

Enrollment

200 participants

Start Date

Jan 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 37 WeeksMax Age: 42 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Bionix ShotBlocker, Masimo Rad-97 Oximeter probe, and others for people with neonatal pain. The study is currently recruiting participants at 1 location. People eligible for this study include aged 37 Weeks to 42 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBionix 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.

OTHERSwaddling

Standard of care swaddling

OTHERSucrose administration

Standard of care sucrose administration

OTHERMasimo Rad-97 Oximeter probe

Oximeter probe


Locations(1)

UMass Memorial Medical Center- Memorial Campus

Worcester, Massachusetts, United States

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NCT06624176