ShotBlocker During Intramuscular Injection Randomized Control Trial

Not Applicable

Recruiting

• Conditions: Neonatal Pain
• Interventions: Device: Bionix ShotBlocker; Other: Swaddling; Other: Sucrose administration; Other: Masimo Rad-97 Oximeter probe

• Registration Number: NCT06624176
• Lead Sponsor: Lauren Fortier

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-10
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-09-30
• Study First Posted: 2024-10-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-07-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ShotBlocker Administration	Swaddling	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.
ShotBlocker Administration	Sucrose administration	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.
ShotBlocker Administration	Masimo Rad-97 Oximeter probe	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.
Standard of Care Comfort Tools	Swaddling	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.
Standard of Care Comfort Tools	Sucrose administration	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.
Standard of Care Comfort Tools	Masimo Rad-97 Oximeter probe	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.
ShotBlocker Administration	Bionix ShotBlocker	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.

Primary Outcome Measures

Name	Time	Method
Difference in the heart rate before, during, and after Hepatitis B vaccine injection between the control and intervention groups.	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.
Difference in the blood oxygen saturation before, during, and after Hepatitis B vaccine injection between the control and intervention groups.	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 Outcome Measures

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

Trial Locations

Locations (1)

UMass Memorial Medical Center- Memorial Campus; 🇺🇸 Worcester, Massachusetts, United States