Clinical trial NCT06624176: ShotBlocker During Intramuscular Injection Randomized Control Trial
Official title: The Effect of ShotBlocker on Pain in Full Term Infants Undergoing Intramuscular Injection: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Pain
Keywords: ShotBlocker
Neonatal Pain
Needlestick
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 200
Sex: ALL
Minimum age (years): 37
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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 attempted at least one oral feeding
* No circumcision in the last 6 hours
* Parental consent for Hepatitis B vaccine

Exclusion Criteria:

* 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
* Diagnosis of Neonatal Abstinence Syndrome (NAS)
* Infants who are simultaneously receiving Hepatitis B Immunoglobulin or Nirsevimab (RSV vaccine)
* Department of Children and Families (DCF) custody

Primary outcomes:
measure: Difference in the heart rate before, during, and after Hepatitis B vaccine injection between the control and intervention groups.
timeFrame: up to 4 minutes
measure: Difference in the blood oxygen saturation before, during, and after Hepatitis B vaccine injection between the control and intervention groups.
timeFrame: up to 4 minutes
Secondary outcomes:
measure: Difference in pain score before, during, and after Hepatitis B vaccine injection between the control and intervention groups.
timeFrame: up to 3 minutes
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center- Memorial Campus
state: Massachusetts
Study officials:
affiliation: Pediatric Nurse Practitioner for the Department of Pediatrics & PICU
name: Lauren Fortier, CPNP, MSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Talebi M, Amiri SRJ, Roshan PA, Zabihi A, Zahedpasha Y, Chehrazi M. The effect of concurrent use of swaddle and sucrose on the intensity of pain during venous blood sampling in neonate: a clinical trial study. BMC Pediatr. 2022 May 10;22(1):263. doi: 10.1186/s12887-022-03323-0.
citation: Caglar S, Buyukyilmaz F, Cosansu G, Caglayan S. Effectiveness of ShotBlocker for Immunization Pain in Full-Term Neonates: A Randomized Controlled Trial. J Perinat Neonatal Nurs. 2017 Apr/Jun;31(2):166-171. doi: 10.1097/JPN.0000000000000256.
citation: Drago LA, Singh SB, Douglass-Bright A, Yiadom MY, Baumann BM. Efficacy of ShotBlocker in reducing pediatric pain associated with intramuscular injections. Am J Emerg Med. 2009 Jun;27(5):536-43. doi: 10.1016/j.ajem.2008.04.011.
citation: Susilawati, Susilawati, Soetjiningsih Soetjiningsih, Bagus Ngurah Putu Arhana and Ida Bagus Subanada. "Effectiveness of PainAway® on hepatitis B intramuscular injection in term neonates: a randomized controlled trial." Paediatrica Indonesiana 50 (2010): 214. doi:10.14238/PI50.4.2010.214-9
citation: McNair C, Campbell-Yeo M, Johnston C, Taddio A. Nonpharmacologic Management of Pain During Common Needle Puncture Procedures in Infants: Current Research Evidence and Practical Considerations: An Update. Clin Perinatol. 2019 Dec;46(4):709-730. doi: 10.1016/j.clp.2019.08.006. Epub 2019 Aug 26.