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Relieving Pediatric Immunization Pain Using A Reusable Personal Device

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
93871
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
HD056647
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
MMJ LABS, LLC
MMJ LABS, LLC 322 SUTHERLAND PL NE ATLANTA, GA 30307 2327
View profile »
Woman-Owned: Yes
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2009
Title: Relieving Pediatric Immunization Pain Using A Reusable Personal Device
Agency: HHS
Contract: 1R44HD056647-01A2
Award Amount: $123,920.00
 

Abstract:

DESCRIPTION (provided by applicant): Needle sticks are the most frequent and most distressing medical procedure children experience. Resultant needle phobia decreases parents' compliance with immunizations and affects patients' subsequent interactions with health care systems, resulting in delayed diagnoses, refusal to donate blood, and even death. Current products rely on health care professionals to voluntarily use messy, ineffective, and time-consuming interventions for a pain many consider insignificant . An immediately effective reusable pain relief device available directly to consumers could reduce morbidity and suffering worldwide. The market for rapid venipuncture pain relief is large; the market for immediate immunization relief is larger and untapp ed. A small non-invasive device placed centimeters proximal to the needle site significantly reduced venipuncture pain in adults without impacting IV start success. Phase I of this project evaluates pain and anxiety relief, ease of use, and product accepta nce using the device versus standard care in 60 children ages 4 - 6 receiving school-entry immunizations. Concurrently, the prototype will be enhanced to promote pediatric pain relief with distracting cute designs. Phase II of the project is a three arm, p lacebo-controlled trial to demonstrate pain reduction in four age groups receiving scheduled vaccinations: 4-6 months (n=120), 12-15 months (n=60), 4-6 years (n=60), and 11-12 years (n=75). Using a variety of age-appropriate measures, pain relief will be a ssessed by videotape coding by blinded researchers, and by parent, nurse, and child self-report when appropriate. Patients will be randomized to one of three groups: placebo, standard care, and using the device. Further professional design will incorporate microelectronic enhancement, internal cooling components, the option to grab and bunch skin for self-injection, durability testing, and power efficiency improvement. Copious literature alludes to the impact of pediatric needle pain and the lack of a good solution. The proposed device overcomes failings in existing products and is easy for consumers to bring to the doctor and apply themselves. These projects will improve and demonstrate the efficacy of a much-needed intervention for pain inflicted on every child. PUBLIC HEALTH RELEVANCE: This project seeks to optimize and test in children a novel inexpensive reusable device to reduce or eliminate immunization pain. Pediatric needle pain leads to reluctance to access health care, delayed diagnoses, noncomplia nce with vaccines and treatment, and refusal to donate blood. Reducing needle pain is an overlooked opportunity to reduce suffering worldwide.

Principal Investigator:

Amy L. Baxter
4043711190
AMY_BAXTER@PEMA-LLC.COM

Business Contact:

Amy Baxter
amy_baxter@PEMA-LLC.com
Small Business Information at Submission:

MMJ LABS, LLC
MMJ LABS, LLC 322 SUTHERLAND PL NE ATLANTA, GA 30307

EIN/Tax ID: 120584579
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No