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

Trial Summary

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 data supports the effectiveness of the treatment ShotBlocker for reducing pain in infants?

Research shows that ShotBlocker is effective in reducing pain during injections in infants. In a study with newborns receiving their first hepatitis B vaccine, those using ShotBlocker had lower pain scores and heart rates compared to those who did not use it. ^{1 2 3 4 5}

How is the ShotBlocker treatment different from other treatments for infant pain?

The ShotBlocker is unique because it is a simple, non-drug device that reduces pain by applying pressure and distraction at the injection site, unlike other treatments that may involve medications or more complex procedures. ^{6 7 8 9 10}

What is the purpose of this 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.

Research Team

Lauren Fortier, CPNP, MSN

Principal Investigator

Pediatric Nurse Practitioner for the Department of Pediatrics & PICU

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of ShotBlocker in reducing pediatric pain associated with intramuscular injections. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of ShotBlocker for Immunization Pain in Full-Term Neonates: A Randomized Controlled Trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the ShotBlocker for children's immunization distress. [2009]

4. Korea (South) 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. Finland pubmed.ncbi.nlm.nih.gov

[Special features of biological drug therapy in children]. [2016]

7. Bulgaria pubmed.ncbi.nlm.nih.gov

Drug-neutralizing Antibodies against TNF-α blockers as Biomarkers of Therapy Effect Evaluation. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Infusion-Related Reactions to Intravenous Infliximab and Subcutaneous Ustekinumab in Pediatric Crohn's Disease. [2022]

9. England 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. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Drug reactions in children with rheumatic diseases receiving parenteral therapies: 9 years' experience of a tertiary pediatric rheumatology center. [2021]