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

NCT01800318 | Completed Results DMC

• 1 other identifier: 109236
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain

Keywords

NESAP; sucrose; pain; infants

Outcome Measures

Primary Outcomes (1)

• Changes From Baseline Premature Infant Pain Profile (PIPP) Score to Average PIPP Score During Heel Stick and Squeeze.

  The PIPP score includes assessment of contextual, physiological, and behavioral parameters and has been extensively validated for pain assessment in preterm and term infants. PIPP scores were given at baseline before initiation of the TENS unit,and every 30 seconds for the first two minutes of the heel stick and heel squeeze (4 times). The four PIPP scores given during heel stick and squeeze were averaged. Behavioral portion of PIPP score: facial expressions are videotaped and analyzed. Physiologic portion of PIPP score: Oxygen saturation levels and heart rates are recorded at baseline and then continuously throughout initiation of the TENS unit and the heel stick procedure. Contextual score - gestational age + sleep/wake state. Subscale scores are added for a total PIPP score. Total or composite PIPP scores are reported. Scores on the PIPP for full term infants range from 0-18, with 0 being no pain, 1-6 minimal pain, 7-12 moderate pain, 13-18 severe pain.

  Baseline and first two minutes of heel stick an squeeze. PIPP scores are given every 30 seconds for the first two minutes of the heel stick and squeeze and then averaged..

Secondary Outcomes (4)

• Change in Salivary Cortisol After Heel Stick

  Baseline and 5±0.5 minutes after heel stick

• Change in Heart Rate Variability During Heel Stick

  Baseline, 20 minutes +/- 5 minutes

• Duration of Crying After TENS Unit Was Initiated But Before Heel Stick.

  10 minutes

• Duration of Crying During Heel Stick

  5 minutes +/- 2 minutes

Study Arms (4)

Sham NESAP with 24% oral sucrose

EXPERIMENTAL

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.

Behavioral: 24% oral Sucrose; Device: Sham NESAP

NESAP with oral water

EXPERIMENTAL

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

Device: NESAP; Behavioral: Oral water

NESAP with 24% oral sucrose

EXPERIMENTAL

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.

Device: NESAP; Behavioral: 24% oral Sucrose

Sham NESAP with oral water

PLACEBO COMPARATOR

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.

Device: Sham NESAP; Behavioral: Oral water

Interventions

NESAP 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.

Also known as: NESAP using Empi Select TENS unit

NESAP with 24% oral sucrose; NESAP with oral water

24% oral Sucrose 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.

Also known as: Sweet-Ease

NESAP with 24% oral sucrose; Sham NESAP with 24% oral sucrose

Sham NESAP 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).

Also known as: Sham NESAP using Empi Select TENS unit

Sham NESAP with 24% oral sucrose; Sham NESAP with oral water

Oral water 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 oral water; Sham NESAP with oral water

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• Stanford University: collaborator

Study Sites (2)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72223, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Sucrose; Water

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Limitations and Caveats

We had difficulty collecting adequate saliva for salivary cortisol analysis. Many infants had insufficient saliva to run a reliable analysis, and numbers of infants with adequate saliva samples both before and after the heel stick were limited.

Results Point of Contact

• Title: Richard W. Hall, professor of pediatrics, co-director of neonatal intensive care unit
• Organization: University of Arkansas for Medical Sciences

HallRichardw@uams.edu

501-680-7894

Study Officials

• Richard W Hall, M.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: February 27, 2013
• Study Start: March 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 16, 2017
• Results First Posted: December 11, 2015

Record last verified: 2017-01

Locations

US (2)