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

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

Age range

0–0 years

Sex

All

Healthy volunteers

Yes

Interventions

• Device
  Bionix 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.

• Other
  Swaddling

  Standard of care swaddling

• Other
  Sucrose administration

  Standard of care sucrose administration

• Other
  Masimo Rad-97 Oximeter probe

  Oximeter probe

Location