ShotBlocker for Infant Pain

Overseen By Madeline French, BS MBE

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Lauren Fortier

Must not be taking: Sedatives, Hepatitis B Immunoglobulin, others

Disqualifiers: Swallow dysfunction, Congenital abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Bionix ShotBlocker can reduce pain for newborns receiving their first Hepatitis B vaccine. The ShotBlocker is a tool designed to make shots less painful. In this study, babies will receive either the ShotBlocker with standard comfort measures like swaddling and sugar water, or just the standard measures. The trial seeks healthy newborns at UMass Memorial Medical Center who have already had their first oral feeding and have not recently undergone circumcision. Parents must consent to their baby receiving the Hepatitis B vaccine. As an unphased trial, this study offers an opportunity to contribute to research that could enhance comfort for newborns during vaccinations.

Do I have to stop my current medications for the trial?

The trial does not specify if participants need to stop taking their current medications, but infants who were exposed to sedatives within the last 12 hours are excluded.

What prior data suggests that the ShotBlocker device is safe for infants?

Research has shown that the Bionix ShotBlocker safely and effectively reduces needle pain. It uses small, blunt points to distract from the pain during injections, providing a drug-free option. Made from high-quality, medical-grade materials, it ensures safety and cleanliness. Trusted in healthcare settings, it is designed for easy use by everyone, including babies, children, and adults. No reports of side effects make it a well-tolerated choice for managing injection pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard comfort measures for infant pain, which include swaddling and sucrose, the ShotBlocker adds a physical component designed to interfere with pain signals. This small, flexible device uses blunt contact points to stimulate the skin around the injection site, which can help block pain sensations during vaccinations. Researchers are excited about ShotBlocker because it offers a simple, non-invasive addition to existing methods, potentially making vaccinations less stressful for infants without requiring medication.

What evidence suggests that the ShotBlocker is effective for reducing infant pain during injections?

Research shows that the Bionix ShotBlocker, which participants in this trial may receive, reduces pain during injections. Studies have found it effective in lessening pain when used for the hepatitis B vaccine in newborns. In this trial, researchers will compare the ShotBlocker to standard methods like swaddling and giving sugar water, used in the control group. Pain was measured by observing facial expressions and heart rate, and the ShotBlocker consistently resulted in lower pain scores. Although another device, Buzzy®, was sometimes more effective, the ShotBlocker still significantly reduces pain for injections in infants. ^{6 7 8 9 10}

Who Is on the Research Team?

Lauren Fortier, CPNP, MSN

Principal Investigator

Pediatric Nurse Practitioner for the Department of Pediatrics & PICU

Are You a Good Fit for This Trial?

This trial is for healthy newborns who need their first Hepatitis B vaccine. It's designed to see if a tool called ShotBlocker can help reduce the pain of the injection when used with other comforting methods like swaddling and giving sugar water.

Inclusion Criteria

Infants born at UMass Memorial Medical Center (UMMMC) via vaginal delivery or cesarean delivery and under the care of the nursery team

Apgar score above 7 at 5 minutes

I have tried eating by mouth at least once.

Exclusion Criteria

Department of Children and Families (DCF) custody

My newborn has been diagnosed with NAS.

My infant has broken skin on their thigh, hand, or foot.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Administration of Hepatitis B vaccine with ShotBlocker and standard comfort measures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for physiologic and pain response after the injection

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bionix ShotBlocker

Trial Overview The study tests whether using the ShotBlocker, along with wrapping babies snugly (swaddling) and giving them a sweet solution (sucrose), reduces pain from the Hepatitis B shot more than just swaddling and sucrose alone.

How Is the Trial Designed?

Group I: ShotBlocker Administration Experimental Treatment 4 Interventions

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.

Group II: Standard of Care Comfort Tools Active Control 3 Interventions

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.

Bionix ShotBlocker is already approved in United States, Canada for the following indications:

Approved in United States as ShotBlocker for:

• Pain reduction during intramuscular injections

Approved in Canada as ShotBlocker for:

• Pain reduction during intramuscular injections

Who Is Running the Clinical Trial?

Lauren Fortier

Lead Sponsor

Trials

1

Recruited

200+

Published Research Related to This Trial

A randomized trial involving 89 children aged 4 to 12 found that the ShotBlocker, a physical intervention aimed at reducing injection pain, did not significantly decrease pain or anxiety compared to placebo or typical care.

Despite the expectation that the ShotBlocker would help, all groups experienced similar levels of distress during immunizations, indicating that this intervention may not be effective for managing acute pain in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the ShotBlocker for children's immunization distress. Cobb, JE., Cohen, LL.[2009]

In a study involving 23 children with juvenile idiopathic arthritis, the prefilled pen for subcutaneous methotrexate administration was preferred by 82.6% of patients and caregivers over the prefilled syringe due to its ease of use and reduced pain during injection.

The use of the prefilled pen also resulted in fewer side effects, particularly gastrointestinal issues, indicating it may be a safer and more effective option for delivering methotrexate in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prefilled pen versus prefilled syringe: a pilot study evaluating two different methods of methotrexate subcutaneous injection in patients with JIA. Roszkiewicz, J., Swacha, Z., Smolewska, E.[2021]

TNFα blockers are the most commonly used biological drugs for treating pediatric inflammatory diseases like juvenile arthritis and inflammatory bowel diseases, showing effective management of these conditions.

Severe safety risks from biological drug therapy in children are very rare, and treatment can be personalized through drug level measurements and anti-drug antibody tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Special features of biological drug therapy in children]. Aalto, K., Leinonen, S., Kolho, KL., et al.[2016]

In a study involving 150 children aged 7 to 12, both Buzzy® and ShotBlocker® significantly reduced pain from intramuscular penicillin injections compared to a control group.

Buzzy® was found to be more effective than ShotBlocker® in minimizing pain during the injections, indicating its potential as a preferred pain management tool in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect on Pain of Buzzy® and ShotBlocker® during the Administration of Intramuscular Injections to Children: A Randomized Controlled Trial. Sivri Bilgen, B., Balcı, S.[2020]

A 9-year-old boy with Crohn's disease experienced an allergic reaction to ustekinumab (UST) after subcutaneous injections, despite tolerating the initial intravenous dose without issues, highlighting the need for careful monitoring of reactions to biological agents in pediatric patients.

The case emphasizes the importance of distinguishing between true infusion-related reactions and allergic reactions, as premedication may allow continued use of a biological agent in the former, while anaphylaxis would necessitate switching to a different treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Infusion-Related Reactions to Intravenous Infliximab and Subcutaneous Ustekinumab in Pediatric Crohn's Disease. Kakiuchi, T., Kimura, S., Esaki, M., et al.[2022]

In a study of 413 children with rheumatic diseases treated with parenteral medications, the most common side effects included nausea and vomiting, occurring after an average of three administrations, highlighting the need for careful monitoring.

The study emphasizes the importance of experienced healthcare professionals in administering parenteral treatments, as some patients experienced hypersensitivity reactions that required additional interventions like antihistamines and steroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug reactions in children with rheumatic diseases receiving parenteral therapies: 9 years' experience of a tertiary pediatric rheumatology center. Koç, R., Sönmez, HE., Çakan, M., et al.[2021]

In a randomized, placebo-controlled trial involving 180 adults, the use of ShotBlocker during intramuscular injections significantly reduced pain intensity compared to control and placebo groups.

While ShotBlocker effectively alleviated pain from the injection, it did not reduce anxiety levels, indicating its specific role as a pain-relieving tool rather than an anxiety-reducing one.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of ShotBlocker for Reducing the Pain and Anxiety Associated With Intramuscular Injection: A Randomized, Placebo Controlled Study. Çelik, N., Khorshid, L.[2015]

In a study of 165 children aged 2 months to 17 years, the use of ShotBlocker during intramuscular injections significantly reduced perceived pain scores from nurses and caregivers compared to a no-intervention group.

While caregivers and nurses reported lower pain levels with ShotBlocker, children aged 36 months and older did not show a significant difference in their self-reported pain, indicating that the device may be more effective in reducing perceived pain by adults rather than the children themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ShotBlocker in reducing pediatric pain associated with intramuscular injections. Drago, LA., Singh, SB., Douglass-Bright, A., et al.[2009]

In a randomized controlled trial involving 100 healthy term neonates, the use of ShotBlocker significantly reduced pain scores during and after the hepatitis B vaccine injection compared to a control group.

The ShotBlocker group not only experienced lower pain levels but also had a lower post-injection heart rate, indicating a more favorable physiological response to the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of ShotBlocker for Immunization Pain in Full-Term Neonates: A Randomized Controlled Trial. Caglar, S., Büyükyılmaz, F., Coşansu, G., et al.[2018]

In a study of 121 patients with inflammatory joint diseases, drug-induced neutralizing antibodies against the TNF-α blocker adalimumab were found to increase over time, reaching 24.8% at 24 months, which correlated strongly with poor clinical responses.

While neutralizing antibodies to etanercept were less common, their presence also indicated a negative impact on treatment efficacy, suggesting that monitoring these antibodies could serve as a reliable biomarker for assessing the effectiveness of TNF-α blocker therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-neutralizing Antibodies against TNF-α blockers as Biomarkers of Therapy Effect Evaluation. Kraev, K., Geneva-Popova, M., Popova, V., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735675708003082

Efficacy of ShotBlocker in reducing pediatric pain ... The aim of the study was to determine the efficacy of ShotBlocker (Bionix, Toledo, Ohio) in reducing pediatric pain with intramuscular (IM) injections. Methods.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28437308/

Effectiveness of ShotBlocker for Immunization Pain in Full- ... The use of ShotBlocker during the hepatitis B vaccine in term neonates is effective in reducing the acute pain.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06624176

ShotBlocker During Intramuscular Injection Randomized ... 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.

4. journals.lww.com journals.lww.com/jpnnjournal/Fulltext/2017/04000/Effectiveness_of_ShotBlocker_for_Immunization_Pain.15.aspx?generateEpub=Article%7Cjpnnjournal:2017:04000:00015%7C10.1097/jpn.0000000000000256%7C

Effectiveness of ShotBlocker for Immunization Pain in Full- ... The primary outcome was pain as measured with the Neonatal Infant Pain Scale (NIPS). Secondary outcomes were heart and respiratory rate. Accordingly, the ...

5. synapse.koreamed.org synapse.koreamed.org/upload/synapsedata/pdfdata/0006jkan/jkan-49-486.pdf

The Effect on Pain of Buzzy® and ShotBlocker® during the ... Conclusion: Buzzy® was more effective compared with ShotBlocker® in this study. Key words: Pain; Child; Cold Temperature; Vibration; ...

6. bionix.com bionix.com/products/shotblocker

ShotBlocker ® Injection Relief A drug-free, cost-effective solution that instantly reduces needle pain by using blunt contact points to distract from pain signals. Easy to use and versatile, ...

7. amazon.com amazon.com/Bionix-ShotBlocker-Pain-Free-Immunizations-Injections/dp/B08VS34SQ5

Amazon.com: Bionix - ShotBlocker, Eases Discomfort from ... Bionix - ShotBlocker, Eases Discomfort from Immunizations & Injections, Great Alternative to Numbing Creams, Use at Home or On-The-Go, Safe for Kids

8. sntbiotech.com sntbiotech.com/products/bionix-shotblocker%C2%AE-8050?srsltid=AfmBOooRdmwbQHlWmGX34f2qYzFJqHJd4jtx9k1HECNgptUpi9xAIE8n

SNT Biotech BIONIX SHOTBLOCKER® - 8050 – SNTBIOTECH Safety & Compliance Documents. Material Safety Data Sheets (MSDS) or Safety Data Sheets (SDS) are available upon request ...

9. bettymills.com bettymills.com/shotblocker-pain-management-device-shotblocker-8100-mon447762bx?srsltid=AfmBOoqhQ8LJjZ0_YF3IUWlQAivMqDJcfyGqWa2WfxuMN80F_Jyljemz

Bionix Pain Management Device Shotblocker Safe and Hygienic: Made from high-quality, medical-grade materials to ensure patient safety and comfort. Produced by Bionix, a trusted name in healthcare ...

10. bionix.com bionix.com/products/injection-relief

ShotBlocker ® Injection Relief Reduce anxiety during injections. Child receiving an injection with ShotBlocker to reduce the pain.