ShotBlocker During Intramuscular Injection Randomized Control Trial

NCT06624176 | Recruiting FDA Device

• 1 other identifier: STUDY00001110
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Pain

Keywords

ShotBlocker; Neonatal Pain; Needlestick

Outcome Measures

Primary Outcomes (2)

• Difference in the heart rate before, during, and after Hepatitis B vaccine injection between the control and intervention groups.

  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.

  up to 4 minutes

• Difference in the blood oxygen saturation before, during, and after Hepatitis B vaccine injection between the control and intervention groups.

  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.

  up to 4 minutes

Secondary Outcomes (1)

• Difference in pain score before, during, and after Hepatitis B vaccine injection between the control and intervention groups.

  up to 3 minutes

Study Arms (2)

ShotBlocker Administration

EXPERIMENTAL

The treatment group will employ the medical device of interest, ShotBlocker, bundled with the standard-of-care comfort measures of swaddling and sucrose during the administration of the Hepatitis B Immunization. A Masimo Rad-97 Oximeter probe will be applied to record a baseline and intervention physiologic response. There will be an Opt-In Video Recording option to assign a pain score (PIPP Scale) during the procedure by a blinded medical professional.

Device: Bionix ShotBlocker; Other: Swaddling; Other: Sucrose administration; Other: Masimo Rad-97 Oximeter probe

Standard of Care Comfort Tools

ACTIVE COMPARATOR

The control group will employ the standard-of-care comfort measures of swaddling and sucrose during the administration of the Hepatitis B Immunization. A Masimo Rad-97 Oximeter probe will be applied to record a baseline and intervention physiologic response. There will be an Opt-In Video Recording option to assign a pain score (PIPP Scale) during the procedure by a blinded medical professional.

Other: Swaddling; Other: Sucrose administration; Other: Masimo Rad-97 Oximeter probe

Interventions

Swaddling OTHER

Standard of care swaddling

ShotBlocker Administration; Standard of Care Comfort Tools

Bionix ShotBlocker DEVICE

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.

ShotBlocker Administration

Sucrose administration OTHER

Standard of care sucrose administration

ShotBlocker Administration; Standard of Care Comfort Tools

Masimo Rad-97 Oximeter probe OTHER

Oximeter probe

ShotBlocker Administration; Standard of Care Comfort Tools

Eligibility Criteria

• Age: 37 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lauren Fortier: lead

Study Sites (1)

UMass Memorial Medical Center- Memorial Campus

Worcester, Massachusetts, 01605, United States

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Needlestick Injuries

Condition Hierarchy (Ancestors)

Wounds, Stab; Wounds, Penetrating; Wounds and Injuries

Study Officials

• Lauren Fortier, CPNP, MSN

  Pediatric Nurse Practitioner for the Department of Pediatrics & PICU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeline French, BS MBE

CONTACT

5088870106; madeline.french2@umassmed.edu

Samia Binta Rahman, MBBS MPH

CONTACT

6034179792; samiabinta.rahman6@umassmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: October 2, 2024
• Study Start: January 10, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)