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

Qualifiers

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

Treatments tested in this trial

  • Bionix ShotBlocker
  • Swaddling
  • Sucrose administration
  • Masimo Rad-97 Oximeter probe

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Lauren Fortier

Lead sponsor

University of Massachusetts, Worcester

Sponsor institution