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NCT Number: NCT06624176

ShotBlocker During Intramuscular Injection Randomized Control Trial

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.

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Key information

Conditions

Neonatal Pain Needlestick Injuries Wounds and Injuries Wounds, Penetrating Wounds, Stab

Age range

37 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Memorial Medical Center- Memorial Campus

Worcester, Massachusetts, 01605, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

Exclusion criteria

  • 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

Treatment and study plan

Bionix ShotBlocker

Device

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.

Swaddling

Other

Standard of care swaddling

Sucrose administration

Other

Standard of care sucrose administration

Masimo Rad-97 Oximeter probe

Other

Oximeter probe

Primary outcomes

  1. Difference in the heart rate before, during, and after Hepatitis B vaccine injection between the control and intervention groups.

    Time frame: up to 4 minutes

    The primary outcome measure is the difference in the physiologic response before, during, and after the injection between the control and intervention groups as reflected as heart rate. Difference in heart rate will be evaluated through the measurements of heart rate recorded by a Masimo Rad-97 Oximeter.

  2. Difference in the blood oxygen saturation before, during, and after Hepatitis B vaccine injection between the control and intervention groups.

    Time frame: up to 4 minutes

    The primary outcome measure is the difference in the physiologic response before, during, and after the injection between the control and intervention groups as reflected by blood oxygen saturation. Difference in blood oxygen saturation will be evaluated through transcutaneous measurements recorded by a Masimo Rad-97 Oximeter.

Secondary outcomes

  1. Difference in pain score before, during, and after Hepatitis B vaccine injection between the control and intervention groups.

    Time frame: up to 3 minutes

    The secondary outcome measure is the difference in the pain score using the Premature Infant Pain Profile (PIPP) before, during, and after injection between the control and intervention groups. PIPP scores range from 0 to 15 and a lower score indicates a better outcome. For example, a PIPP score of 0 indicates no pain. There will be an Opt-In Video Recording option to assign a PIPP score before, during, and after vaccine administration. Infant response will be filmed during injection and evaluated by a blinded medical professional that did not participate in study procedures to assign a PIPP score.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Lauren Fortier

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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