Does Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) Reduce Heelstick Pain in Infants?

NACompletedINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Pain
Interventions
DEVICE

NESAP

Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points: ZuSanLi (ST36), SanYinJiao (SP6), Shen Mai (Bl60), and Shui Quan (KI3)46. StimCare electrodes with a gel base will be applied to the skin ; the skin will not be punctured by these procedures. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick. The display will be hidden from view to prevent the rater from being able to observe whether the unit is on.

BEHAVIORAL

24% oral Sucrose

One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.

DEVICE

Sham NESAP

Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).

BEHAVIORAL

Oral water

For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose.

Trial Locations (2)

72223

University of Arkansas for Medical Sciences, Little Rock

94305

Stanford University, Stanford

All Listed Sponsors
collaborator

Stanford University

OTHER

lead

University of Arkansas

OTHER

NCT01800318 - Does Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) Reduce Heelstick Pain in Infants? | Biotech Hunter | Biotech Hunter