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

NCT ID: NCT01800318

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-02-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sham NESAP with 24% oral sucrose

1. 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.

2. 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.

Group Type: EXPERIMENTAL

24% oral Sucrose

Intervention Type: BEHAVIORAL

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.

Sham NESAP

Intervention Type: DEVICE

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).

NESAP with oral water

1. 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.

2. 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

Group Type: EXPERIMENTAL

NESAP

Intervention Type: DEVICE

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.

Oral water

Intervention Type: BEHAVIORAL

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.

NESAP with 24% oral sucrose

1. 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.

2. 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.

Group Type: EXPERIMENTAL

NESAP

Intervention Type: DEVICE

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.

24% oral Sucrose

Intervention Type: BEHAVIORAL

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.

Sham NESAP with oral water

1. 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.

2. 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.

Group Type: PLACEBO_COMPARATOR

Sham NESAP

Intervention Type: DEVICE

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).

Oral water

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

NESAP using Empi Select TENS unit; Sweet-Ease; Sham NESAP using Empi Select TENS unit

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard W Hall, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

109236

Identifier Type: -

Identifier Source: org_study_id