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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8 months
Maximum Age: 9 months
Healthy Volunteers: t
View:

• 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

Locations
United States
Massachusetts
UMass Memorial Medical Center- Memorial Campus
RECRUITING
Worcester
Contact Information
Primary
Madeline French, BS MBE
madeline.french2@umassmed.edu
5088870106
Backup
Samia Binta Rahman, MBBS MPH
samiabinta.rahman6@umassmed.edu
6034179792
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2025-09-15
Participants
Target number of participants: 200
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Lauren Fortier

This content was sourced from clinicaltrials.gov

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