NCT01800318

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 1 Day – 3 Days
• Healthy volunteers: Accepted

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. 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.

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 (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: 1. Group A: Sham (fake electrical stimulation) plus sugar water with pacifier before heelstick. 2. Group B: Electrical stimulation plus water with pacifier before heelstick. 3. Group C: Electrical stimulation plus sugar water with pacifier before heelstick. 4. 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.

Conditions

• Pain

Interventions

Type	Name	Description
DEVICE	NESAP	Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points: ZuSanLi (ST36), SanYinJiao (SP6), Shen Mai (Bl60), and Shui Quan (KI3)46. StimCare electrodes with a gel base will be applied to the skin ; the skin will not be punctured by these procedures. A low continuous current will be provided with minimal 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 2 minutes after the heel stick. The display will be hidden from view to prevent the rater from being able to observe whether the unit is on.
BEHAVIORAL	24% oral Sucrose	One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.
DEVICE	Sham NESAP	Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).
BEHAVIORAL	Oral water	For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-02-27
• Last updated: 2017-01-16
• Results posted: 2015-12-11

Locations

2 sites across 1 country: United States