ShotBlocker During Intramuscular Injection Randomized Control Trial

Description

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

Study Overview

Study Details

Study overview

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.

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

ShotBlocker During Intramuscular Injection Randomized Control Trial

Condition
Neonatal Pain
Intervention / Treatment

-

Contacts and Locations

Worcester

UMass Memorial Medical Center- Memorial Campus, Worcester, Massachusetts, United States, 01605

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Infants born at UMass Memorial Medical Center (UMMMC) via vaginal delivery or cesarean delivery and under the care of the nursery team
  • * Term infants (37 to 42 weeks gestational age)
  • * No acute illness that causes pain
  • * Apgar score above 7 at 5 minutes
  • * Have successfully attempted at least one oral feeding
  • * No circumcision in the last 6 hours
  • * Parental consent for Hepatitis B vaccine
  • * Swallow dysfunction
  • * Congenital or genetic abnormalities
  • * Infants who were exposed to sedatives within the last 12 hours
  • * Infants with skin on thigh, hand, or foot that is not intact
  • * Diagnosis of Neonatal Abstinence Syndrome (NAS)
  • * Infants who are simultaneously receiving Hepatitis B Immunoglobulin or Nirsevimab (RSV vaccine)
  • * Department of Children and Families (DCF) custody

Ages Eligible for Study

37 Weeks to 42 Weeks

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Lauren Fortier,

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

Study Record Dates

2025-04-15