Neonatal PainNCT06624176
ShotBlocker During Intramuscular Injection Randomized Control Trial
A study testing Bionix ShotBlocker, Swaddling and Sucrose administration in people with Neonatal Pain, run by Lauren Fortier at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 37 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal Pain
- What is being tested?
- Bionix ShotBlocker, Swaddling and Sucrose administration
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UMass Memorial Medical Center- Memorial Campus
Worcester, Massachusetts, 01605
Madeline E French, BS MBE, 5088870106, madeline.french2@umassmed.edu
Samia Binta Rahman, MBBS MPH, 6034179792, samiabinta.rahman6@umassmed.edu
About this study
Official title: 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.
- Conditions
- Neonatal Pain
- Being tested
- Bionix ShotBlocker, Swaddling, Sucrose administration, Masimo Rad-97 Oximeter probe
- Keywords
- ShotBlocker, Neonatal Pain, Needlestick
- Medical subject headings
- Needlestick Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bionix ShotBlockerDevice
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.
SwaddlingOther
Standard of care swaddling
Sucrose administrationOther
Standard of care sucrose administration
Masimo Rad-97 Oximeter probeOther
Oximeter probe
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Swaddling; Other: Sucrose administration; Other: Masimo Rad-97 Oximeter probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: up to 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start10 Jan 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neonatal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lauren Fortier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lauren Fortier, University of Massachusetts, Worcester
- Investigators
- Lauren Fortier, CPNP, MSN, Principal investigator, Pediatric Nurse Practitioner for the Department of Pediatrics & PICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624176
- Sponsor's protocol ID
- STUDY00001110
- Status last verified
- Oct 2026
- First submitted
- 2 May 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 35538448Caglar 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.
PubMed 28437308Drago 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.
PubMed 19497458Susilawati, 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.
PubMed 31653304
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of ShotBlocker on Pain in Full Term Infants Undergoing Intramuscular Injection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06624176
- Acronym / sponsor ID
- STUDY00001110
- Conditions
- Neonatal Pain
- Keywords
- ShotBlocker, Neonatal Pain, Needlestick
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lauren FortierUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ShotBlocker Administration | Experimental | Device: Bionix ShotBlocker, Other: Swaddling, Other: Sucrose administration, Other: Masimo Rad-97 Oximeter probeThe 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. |
| Standard of Care Comfort Tools | Active comparator | Other: Swaddling, Other: Sucrose administration, Other: Masimo Rad-97 Oximeter probeThe 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. |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bionix ShotBlockerThis 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. | Device | ShotBlocker Administration |
| SwaddlingStandard of care swaddling | Other | ShotBlocker Administration, Standard of Care Comfort Tools |
| Sucrose administrationStandard of care sucrose administration | Other | ShotBlocker Administration, Standard of Care Comfort Tools |
| Masimo Rad-97 Oximeter probeOximeter probe | Other | ShotBlocker Administration, Standard of Care Comfort Tools |
Primary outcome
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
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.
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
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.
1 secondary outcome
Difference in pain score before, during, and after Hepatitis B vaccine injection between the control and intervention groups.
Time frame: up to 3 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 35538448Talebi 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.
- Background: PubMed 28437308Caglar 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.
- Background: PubMed 19497458Drago 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.
- BackgroundSusilawati, 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: PubMed 31653304McNair 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Fortier, CPNP, MSN principal investigator
Pediatric Nurse Practitioner for the Department of Pediatrics & PICU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bionix ShotBlocker, Swaddling and Sucrose administration in people with Neonatal Pain, run by Lauren Fortier at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeline French, BS MBE (5088870106, madeline.french2@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06624176, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.