ShotBlocker During Intramuscular Injection Randomized Control Trial

Conditions

• Neonatal Pain

Eligibility Criteria

Sex

ALL

Age

37 Weeks - 42 Weeks

Healthy Volunteers

Accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Jan 10, 2024

Status verified

Sep 2025

Primary completion

Sep 1, 2026

Completion

Oct 1, 2026

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: ShotBlocker 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.
• Active Comparator: Standard of Care Comfort Tools
  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.

Primary Outcome Measure

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 ]

Central Contacts

• Madeline French, BS MBE
  5088870106
  [email protected]
• Samia Binta Rahman, MBBS MPH
  6034179792
  [email protected]

Locations (1)

Find similar trials in Worcester, MA