ShotBlocker During Intramuscular Injection Randomized Control Trial
Recruiting
N/A
Interventional Study
Neonatal Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 37 Weeks – 42 Weeks
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 200 (estimated)
- Sponsor
- Lauren Fortier · Other
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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. T…
Trial Locations
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Eligibility Criteria
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 att…
Contacts