N/A N=30 Treatment

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

Pain

Bottom Line

View on ClinicalTrials.gov: NCT01495286 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2012

Primary outcome: Primary: Heart Rate During Treatment With TENS Unit — 137; 131; 133; 133 beats per minute

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EMPI Select Transcutaneous Electrical Nerve Stimulation (Device)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Arkansas
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Heart Rate During Treatment With TENS Unit	137; 131; 133; 133	—
PRIMARY Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick	98; 97; 96	—
SECONDARY Blood Pressure During TENS Treatment and Heel Stick	85; 84; 84; 83	—
SECONDARY Pain During TENS Treatment and Routine Heel Stick	2.17; 2.8; 1.57; 3.17; 8.88; 8.13	—
SECONDARY Skin Assessment	0; 0; 0; 0	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Newborn infants born at 37-42 weeks gestational age and less than 3 days of age requiring a heelstick for clinically indicated blood sampling.
A normal neurological assessment

Exclusion Criteria

Newborns who have received any analgesic treatment
Infants exposed to chronic opiates in utero (excluding opiates given only at the time of delivery) or with a positive drug screen based on review of medical records
Infants exposed to birth asphyxia (5-minute Apgar scores of <5 or cord pH <7.0).
Infants on mechanical ventilation.
Newborns with suspected or confirmed neuromuscular diseases, congenital anomalies, or sepsis.
Infants with birth trauma to the lower extremities (bruising or other) or those exposed multiple heelsticks in the previous 24 hours (e.g. requiring frequent glucose or bilirubin measurements).
Infants born from mothers with drug addiction, diabetes, pre-eclampsia, or systemic inflammatory conditions.
Infants with abnormal neurological exams
Infants with congenital heart defects
Any condition the investigator determines will put the subject at risk if participating in the study.
Enrollment / participation in other studies
Dermatological condition(s) in the area of electrode placement or elsewhere
Local or systemic infection documented or suspected
Allergy to the gel or adhesive
Bleeding abnormalities
Connection to other medical equipment or devices that may interfere with the workings or functioning of the TENS unit

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01495286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.