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

Completed · Not applicable · Has a placebo group

Conditions studied: Pain

In brief

The purpose of the study is to determine whether noninvasive electrical stimulation at acupuncture points (NESAP) and/or 24% sucrose is effective in reducing pain in infants during invasive procedures. The investigators hypothesize that: * Gentle noninvasive electrical stimulation at selected acupuncture points and/or oral use of 24% sucrose with pacifier will reduce the newborn infant's responses to heelstick pain, as measured by the Premature Infant Pain Profile (PIPP), heart rate variability, duration of crying, and salivary cortisol levels. * The effects of combined therapies will be additive. * The analgesic effects of NESAP and/or sucrose will continue for the duration of the heelstick, reflected by the first two minutes of heelstick and the first two minutes of recovery.

Key facts

Study ID

NCT01800318

Run by

University of Arkansas

People needed

162

Starts

2013-03-01

Expected to finish

2015-02-01

Last updated by the study team

2017-01-16

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Newborn infants born at 37-42 weeks gestational age
• Less than 3 days of age
• Requiring a heelstick for clinically indicated blood sampling
• Written, informed consent from their parents.

You may not qualify if…

• Newborns who have received any analgesic treatment
• 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.
• Current maternal cigarette smoking.
• 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.
• Abnormal neurological exam
• Congenital heart defects
• Enrollment or participation in other studies
• Dermatologic condition in the area of electrode placement or elsewhere
• Local or systemic infection documented or suspected
• Reasonable known allergy to the gel/adhesive
• Bleeding abnormality
• Connection to other medical equipment or devices that might interfere with the workings or functioning of the transcutaneous electrical nerve stimulation (TENS) unit
• Any condition the investigator determines will put the subject at risk if participating in the study.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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