ShotBlocker During Intramuscular Injection Randomized Control Trial

The Effect of ShotBlocker on Pain in Full Term Infants Undergoing Intramuscular Injection: A Randomized Controlled 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. The investigators hypothesize that the use of ShotBlocker in addition to swaddling and oral sucrose administration will lessen the pain response.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Pain
• Intervention / Treatment: Device: Bionix ShotBlocker; Other: Swaddling; Other: Sucrose administration; Other: Masimo Rad-97 Oximeter probe

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madeline French, BS MBE; Phone Number: 5088870106; Email: madeline.french2@umassmed.edu
• Study Contact Backup: Name: Samia Binta Rahman, MBBS MPH; Phone Number: 6034179792; Email: samiabinta.rahman6@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Recruiting
      • UMass Memorial Medical Center- Memorial Campus
      • Contact: Samia Binta Rahman, MBBS MPH; Phone Number: 6034179792; Email: samiabinta.rahman6@umassmed.edu
      • Contact: Madeline E French, BS MBE; Phone Number: 5088870106; Email: madeline.french2@umassmed.edu
      • Principal Investigator: Lauren Fortier, CPNP MSN
      • Principal Investigator: Lawrence Rhein, MD MPH
      • Sub-Investigator: Mark Vining, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ShotBlocker Administration; 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; 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
Active Comparator: Standard of Care Comfort Tools; 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; Standard of care swaddling; Other: Sucrose administration; Standard of care sucrose administration; Other: Masimo Rad-97 Oximeter probe; Oximeter probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in pain score before, during, and after Hepatitis B vaccine injection between the control and intervention groups.	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.	up to 3 minutes

Collaborators and Investigators

• Sponsor: Lauren Fortier
• Investigators: Principal Investigator: Lauren Fortier, CPNP, MSN, Pediatric Nurse Practitioner for the Department of Pediatrics & PICU

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: ShotBlocker; Needlestick; Neonatal Pain
• Additional Relevant MeSH Terms: Wounds and Injuries; Wounds, Penetrating; Wounds, Stab; Needlestick Injuries
• Other Study ID Numbers: STUDY00001110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes