Neonatal Pain
Conditions
Keywords
ShotBlocker, Neonatal Pain, Needlestick
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.
Interventions
DEVICEBionix ShotBlocker
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.
OTHERSwaddling
Standard of care swaddling
OTHERSucrose administration
Standard of care sucrose administration
OTHERMasimo Rad-97 Oximeter probe
Oximeter probe
Sponsors
Lauren Fortier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
37 Weeks to 42 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactMadeline French, BS MBE
Backup ContactSamia Binta Rahman, MBBS MPH
Outcome results
None listed