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

Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:NESAPElectrical 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 SucroseOne 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 NESAPFour 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 waterFor 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Sham NESAP with 24% oral sucroseSham 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.

NESAP with oral waterNESAP: 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

NESAP with 24% oral sucroseNESAP: 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.

Sham NESAP with oral waterSham 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.

Study Status

Completed

Start Date: March 2013

Completed Date: February 2015

Phase: N/A

Type: Interventional

Design:

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

Secondary Outcome: Change in Salivary Cortisol After Heel Stick

Study sponsors, principal investigator, and references

Principal Investigator: Richard W Hall, M.D.

Lead Sponsor: University of Arkansas

Collaborator: Stanford University

More information:https://clinicaltrials.gov/show/NCT01800318

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