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

University of Arkansas logo

University of Arkansas

Status

Completed

Conditions

Pain

Treatments

Device: NESAP
Behavioral: 24% oral Sucrose
Device: Sham NESAP
Behavioral: Oral water

Study type

Interventional

Funder types

Other

Identifiers

NCT01800318
109236

Details and patient eligibility

About

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.

Full 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 (Palo Alto, CA). After obtaining IRB approval at both sites and parental consent, newborn infants less than 3 days of age who require heelsticks for clinical blood sampling will be randomized in a 2 × 2 factorial trial design to four groups: standard pain management with pacifier and water, Non-invasive Electrical Stimulation of Acupuncture Points (NESAP) with pacifier and water, 24% oral sucrose solution with pacifier, or NESAP plus oral sucrose solution and pacifier prior to their heelstick. We will study the pain response to the heelstick routinely used to obtain blood for term neonatal infants by enrolling up to 192 infants, 96 from University of Arkansas for Medical Sciences and 96 from Lucille Packard Children's Hospital. This number will allow for screen failures and withdrawals. A minimum of 164 infants collectively from both sites is required to complete the study. Infants will be divided into 4 experimental groups: Group A: Sham (fake electrical stimulation) plus sugar water with pacifier before heelstick. Group B: Electrical stimulation plus water with pacifier before heelstick. Group C: Electrical stimulation plus sugar water with pacifier before heelstick. Group D: Sham (fake electrical stimulation) plus water with pacifier before heelstick. 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 a pain scale, heart rate, heart rate variability and oxygen saturation changes, duration of crying, and changes in salivary cortisol levels.

Enrollment

162 patients

Sex

All

Ages

1 to 3 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

162 participants in 4 patient groups, including a placebo group

Sham NESAP with 24% oral sucrose
Experimental group
Description:
Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit. Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
Treatment:
Device: Sham NESAP
Behavioral: 24% oral Sucrose
NESAP with oral water
Experimental group
Description:
NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on with settings 3.5mA, 10 Hz. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit. Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given
Treatment:
Behavioral: Oral water
Device: NESAP
NESAP with 24% oral sucrose
Experimental group
Description:
NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick at settings 3.5 mA, 10 Hz. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit. Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
Treatment:
Behavioral: 24% oral Sucrose
Device: NESAP
Sham NESAP with oral water
Placebo Comparator group
Description:
Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit. Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.
Treatment:
Behavioral: Oral water
Device: Sham NESAP

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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