NCT Number: NCT06624176
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.
Interested in participating?
Request Info37 week–42 week
All sexes
Interventional
Not applicable
Worcester, Massachusetts, 01605, United States
Location status: Recruiting
Lauren Fortier, CPNP MSN
PRINCIPAL_INVESTIGATOR
Lawrence Rhein, MD MPH
PRINCIPAL_INVESTIGATOR
Madeline E French, BS MBE
CONTACT
Mark Vining, MD
SUB_INVESTIGATOR
Samia Binta Rahman, MBBS MPH
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Standard of care swaddling
Standard of care sucrose administration
Oximeter probe
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Madeline French, BS MBE
CONTACT
Samia Binta Rahman, MBBS MPH
CONTACT
Lauren Fortier
Other
The Effect of ShotBlocker on Pain in Full Term Infants Undergoing Intramuscular Injection: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07112430
Agnosia, Analgesia
Halifax, Nova Scotia, Canada
View Trial DetailsNCT07651592
Behavior, Behavioral Symptoms
Kilis, Turkey (Türkiye)
View Trial DetailsNCT07125690
Neonatal Pain, Neurologic Manifestations
Kayseri, Turkey (Türkiye)
View Trial DetailsNCT06635174
Agnosia, Neonatal Pain
Muscat, Muḩāfaz̧at Masqaţ, Oman
View Trial Details