Status:
COMPLETED
Does Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) Reduce Heelstick Pain in Infants?
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
Stanford University
Conditions:
Pain
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief Summary
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...
Detailed Description
A collaborative prospective, double-blind, randomized trial will be performed at the University of Arkansas for Medical Sciences Hospital (Little Rock, AR), and Lucille Packard Children's Hospital (Pa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT01800318
Start Date
March 1 2013
End Date
February 1 2015
Last Update
January 16 2017
Active Locations (2)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72223
2
Stanford University
Stanford, California, United States, 94305