Does Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) Reduce Heelstick Pain in Infants?
Condition: Pain
Study type: Interventional

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.
    

Intervention name(s): NESAP; 24% oral Sucrose; Sham NESAP; Oral water
Intervention type(s): Device; Behavioral; Device; Behavioral
Intervention description(s): 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.; 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.; 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).; 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.
Other intervention name(s): NESAP using Empi Select TENS unit; Sweet-Ease; Sham NESAP using Empi Select TENS unit
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NESAP; sucrose; pain; infants