Pain Clinical Trial
Official title:
Is the Use of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) During a Routine Heelstick Safe in Infants?
This research study represents a pilot, open arm study that will evaluate the safety of
using Non−invasive Electrical Stimulation of Acupuncture Points (NESAP) in 42 newborn
infants less than 3 days of age who require heel sticks for clinical blood sampling. The
investigators plan to enroll 51 infants into the study in order to obtain 42 completed
infants. Two sub studies will precede the main safety study, with 6 infants in each sub
study and 30 infants in the main study. These two sub studies will use electrical
stimulation intensities that are a fraction of the planned intensity of electrical
stimulation that will be used during the main part of the study.
The clinical trial will be performed at the University of Arkansas for Medical Sciences
Hospital (Little Rock, AR). The study will evaluate the pain response to heel stick
routinely used to obtain This blood from 30 term neonatal infants, ages 37 to 42 weeks
Electrical stimulation will be applied at appropriate acupuncture points using a very low
current for 10 minutes, routine for procedural pain. The response to pain will be assessed
using pain scales and physiologic changes.
The investigators hypothesize that the NESAP procedure is safe in newborn infants undergoing
a routine heelstick.
The investigators propose an open label trial to assess the safety of using electrical
stimulation at acupuncture sites in 42 infants receiving a routine heel stick. Two sub
studies will precede the main safety study, with 6 infants in each sub study and 30 infants
in the main study. These sub studies will use electrical stimulation intensities that are a
fraction of the planned intensity of the electrical stimulation that will be used for the
main part of the study.
As part of routine neonatal screening, blood will be collected from a heel stick(s) by
qualified nursing staff in the hospital nursery or in the patient's room. Less than one ml
of blood will be drawn over 1−2 minutes. Study infants will be watched more carefully with
heart rate, respiratory rate, and oxygen saturation performed as part of this study. Infants
not participating in the study will be watched as per usual unit protocol.
Electrical stimulation at acupuncture sites will be administered via an EMPI Select
Transcutaneous Electrical Nerve Stimulation (TENS) unit. To produce analgesia, small
electrodes will be placed on the baby's legs at specific acupuncture points: ZuSanLi (ST36)
just below the knee, triggers release of endorphins; SanYinJiao (SP6) just above the inner
ankle, important point for energy balance; Kun Lun (BL60) depression behind lateral
malleolus, protects local tissue trauma to heel; and Tai Xi (Ki3) behind the inner ankle, an
important energy meridian. 25, 39, 48-50, StimCare self-adhesive electrodes with a gel base
will be applied to the skin; the skin will not be punctured by these procedures. For the
main part of the study, a low continuous current will be provided with minimal voltage of
3.5 milliamps (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
heelstick. This paradigm is based on the basic animal research developed by Dr. Han and
other research groups. Two sub studies will precede the main safety study, with 6 infants in
each sub study, 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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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