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RELIEVING PEDIATRIC IMMUNIZATION PAIN USING A REUSABLE PERSONAL DEVICE

Award Number: R44HD056647
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/15/2009
PERIOD OF PERFORMANCE END DATE: 08/31/2011

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RELIEVING PEDIATRIC IMMUNIZATION PAIN USING A REUSABLE PERSONAL DEVICE - 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 untapped. 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 acceptance 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, placebo-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 assessed 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2010 ( Subtotal = $468,634 )
2010	2010	MMJ LABS LLC	322 SUTHERLAND PLACE	ATLANTA	GA	30307	FULTON	USA	Child Health and Human Development Extramural Research	001	3	8/30/2010	NON-COMPETING CONTINUATION	$468,634
2010	2009	MMJ LABS LLC	322 SUTHERLAND PLACE	ATLANTA	GA	30307	FULTON	USA	Child Health and Human Development Extramural Research	000	2	2/8/2010	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $468,634

Issue Date FY: 2009 ( Subtotal = $593,254 )
2009	2009	MMJ LABS LLC	322 SUTHERLAND PLACE	ATLANTA	GA	30307	FULTON	USA	Child Health and Human Development Extramural Research	001	1	9/4/2009	NEW	$0
2009	2009	MMJ LABS LLC	322 SUTHERLAND PLACE	ATLANTA	GA	30307	FULTON	USA	Child Health and Human Development Extramural Research	000	1	2/11/2009	NEW	$123,920
2009	2009	MMJ LABS LLC	322 SUTHERLAND PLACE	ATLANTA	GA	30307	FULTON	USA	Child Health and Human Development Extramural Research	002	2	9/4/2009	EXTENSION WITH OR WITHOUT FUNDS	$469,334
														Subtotal = $593,254

Grand Total All Awards = $1,061,888

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RELIEVING PEDIATRIC IMMUNIZATION PAIN USING A REUSABLE PERSONAL DEVICE

Award Number: R44HD056647

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/15/2009

PERIOD OF PERFORMANCE END DATE: 08/31/2011

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