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Recruiting NCT06624176

ShotBlocker During Intramuscular Injection Randomized Control Trial

No phase Interventional Neonatal Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bionix ShotBlocker, Swaddling, Sucrose administration, Masimo Rad-97 Oximeter probe.
Who it may be relevant to
Registry conditions: Neonatal Pain. Basic parameters: 37 Weeks — 42 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Primary outcome measures

  • Difference in the heart rate before, during, and after Hepatitis B vaccine injection between the control and intervention groups. [Time frame: up to 4 minutes]
  • Difference in the blood oxygen saturation before, during, and after Hepatitis B vaccine injection between the control and intervention groups. [Time frame: up to 4 minutes]
Secondary outcome measures (1)
  • Difference in pain score before, during, and after Hepatitis B vaccine injection between the control and intervention groups. [Time frame: up to 3 minutes]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • UMass Memorial Medical Center- Memorial Campus — Worcester

Publications

  • 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. PMID 35538448
  • 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. PMID 28437308
  • 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. PMID 19497458
  • 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
  • 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. PMID 31653304

Identifiers

NCT: NCT06624176 · STUDY00001110

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗