CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
EMPI Select Transcutaneous Electrical Nerve Stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01495286
NCT01495286N/ACompleted
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Is the Use of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) During a Routine Heelstick Safe in Infants?

University of Arkansas·interventional·Posted Dec 20, 2011·Updated Nov 19, 2012

In Brief

A clinical study evaluating EMPI Select Transcutaneous Electrical Nerve Stimulation for Pain. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
CollaboratorsStanford University

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 20, 2011
Enrollment StartDec 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.5 years ago

Interventions

EMPI Select Transcutaneous Electrical Nerve Stimulationdevice

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.