ShotBlocker During Intramuscular Injection Randomized Control Trial
ConditionNeonatal Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age37-42
SponsorLauren Fortier
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bionix ShotBlocker
DeviceThis 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 interventionStandard of care swaddling
Sucrose administration
Other interventionStandard of care sucrose administration
Masimo Rad-97 Oximeter probe
Other interventionOximeter probe
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: ShotBlocker AdministrationExperimental treatment 4 interventions
Group B: Standard of Care Comfort ToolsActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Difference in the heart rate before, during, and after Hepatitis B vaccine injection between the control and intervention groups.
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.
Time frame
up to 4 minutes2
Difference in the blood oxygen saturation before, during, and after Hepatitis B vaccine injection between the control and intervention groups.
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.
Time frame
up to 4 minutesSecondary outcomes
1
Difference in pain score before, during, and after Hepatitis B vaccine injection between the control and intervention groups.
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.
Time frame
up to 3 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lauren Fortier
Lead sponsor
University of Massachusetts, Worcester
Sponsor institution
Source ClinicalTrials.gov