Safety of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) in Infants

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Pain
Interventions
DEVICE

EMPI Select Transcutaneous Electrical Nerve Stimulation

Experimental: EMPI Select TENS unit For analgesia, StimCare electrodes will be placed on the baby's legs at specific acupuncture points and electrical stimulation will be administered via a standard EMPI Select TENS unit. For the main study, a low continuous current will be provided with 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 5±1 min after the heel stick. Two sub studies will precede the main safety study, with 6 infants in each, using electrical stimulation intensities that are a fraction of the planned intensity. Infants in sub study 1 will receive electrical stimulation at 1 mA and 2 Hz. Infants in sub study 2 will receive electrical stimulation at 2 mA and 10 Hz.

Trial Locations (1)

72205

University of Arkansas for Medical Sciences, Little Rock

All Listed Sponsors
collaborator

Stanford University

OTHER

lead

University of Arkansas

OTHER

NCT01495286 - Safety of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) in Infants | Biotech Hunter | Biotech Hunter