ShotBlocker During Intramuscular Injection Randomized Control Trial

Lauren Fortier

Status: Enrolling

Conditions: Neonatal Pain

Treatments: Other: Masimo Rad-97 Oximeter probe; Other: Sucrose administration; Device: Bionix ShotBlocker; Other: Swaddling

Study type: Interventional

Funder types: Other

Identifiers

NCT06624176

STUDY00001110

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 37 to 42 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

ShotBlocker Administration

Experimental group

Description:

The treatment group will employ the medical device of interest, ShotBlocker, bundled with the standard-of-care comfort measures of swaddling and sucrose during the administration of the Hepatitis B Immunization. A Masimo Rad-97 Oximeter probe will be applied to record a baseline and intervention physiologic response. There will be an Opt-In Video Recording option to assign a pain score (PIPP Scale) during the procedure by a blinded medical professional.

Treatment:

Other: Swaddling

Device: Bionix ShotBlocker

Other: Sucrose administration

Other: Masimo Rad-97 Oximeter probe

Standard of Care Comfort Tools

Active Comparator group

Description:

The control group will employ the standard-of-care comfort measures of swaddling and sucrose during the administration of the Hepatitis B Immunization. A Masimo Rad-97 Oximeter probe will be applied to record a baseline and intervention physiologic response. There will be an Opt-In Video Recording option to assign a pain score (PIPP Scale) during the procedure by a blinded medical professional.

Treatment:

Other: Swaddling

Other: Sucrose administration

Other: Masimo Rad-97 Oximeter probe