Trial Outcomes & Findings for Does Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) Reduce Heelstick Pain in Infants? (NCT NCT01800318)

Last Updated: 2017-01-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

162 participants

Primary outcome timeframe

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..

Results posted on

2017-01-16

Participant Flow

Dates of recruitment: 4/10/2013 until 12/31/2014. Types of location: Postpartal/newborn units at University of Arkansas for Medical Sciences and Lucille Packard Childrens Hospital associated with Stanford University.

All infants enrolled in the study were assigned to groups.

Participant milestones

Participant milestones
Measure	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. 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. 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).	NESAP With Oral Water (a) 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. (b) 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: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. 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. Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick.	NESAP With 24% Oral Sucrose (a) 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. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. 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. 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.	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. 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). 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.
Overall Study STARTED	39	42	41	40
Overall Study COMPLETED	37	37	40	39
Overall Study NOT COMPLETED	2	5	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham NESAP With 24% Oral Sucrose n=39 Participants 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. 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. 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).	NESAP With Oral Water n=42 Participants (a) 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. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs. at specific acupuncture points. 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. 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.	NESAP With 24% Oral Sucrose n=41 Participants (a) 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. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. 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 four specific acupuncture points. 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. 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.	Sham NESAP With Oral Water n=40 Participants 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. 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). 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.	Total n=162 Participants Total of all reporting groups
Age, Continuous	1 days STANDARD_DEVIATION 0.5 • n=5 Participants	1 days STANDARD_DEVIATION 0.5 • n=7 Participants	1 days STANDARD_DEVIATION 0.5 • n=5 Participants	1 days STANDARD_DEVIATION 0.5 • n=4 Participants	1 days STANDARD_DEVIATION 0.5 • n=21 Participants
Gender Female	15 Participants n=5 Participants	26 Participants n=7 Participants	16 Participants n=5 Participants	17 Participants n=4 Participants	74 Participants n=21 Participants
Gender Male	24 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants	23 Participants n=4 Participants	88 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	22 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	37 Participants n=7 Participants	36 Participants n=5 Participants	33 Participants n=4 Participants	140 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	19 Participants n=4 Participants	50 Participants n=21 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	28 Participants n=7 Participants	29 Participants n=5 Participants	17 Participants n=4 Participants	100 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Participants per treatment group	39 participants n=5 Participants	42 participants n=7 Participants	41 participants n=5 Participants	40 participants n=4 Participants	162 participants n=21 Participants

PRIMARY outcome

Timeframe: 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..

Population: Analysis of PIPP scores assigned during heelstick procedure in newborn infants

Outcome measures

Outcome measures
Measure	Sham NESAP With 24% Oral Sucrose n=37 Participants 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. 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. 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).	NESAP With Oral Water n=37 Participants (a) 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. (b) 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: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. 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. Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick.	NESAP With 24% Oral Sucrose n=40 Participants (a) 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. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. 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. 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.	Sham NESAP With Oral Water n=39 Participants 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. 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). 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.
Changes From Baseline Premature Infant Pain Profile (PIPP) Score to Average PIPP Score During Heel Stick and Squeeze.	4.0 units on a scale (PIPP score) Standard Deviation 1.8	5.0 units on a scale (PIPP score) Standard Deviation 4.0	3.6 units on a scale (PIPP score) Standard Deviation 1.2	4.9 units on a scale (PIPP score) Standard Deviation 4.0

SECONDARY outcome

Timeframe: Baseline and 5±0.5 minutes after heel stick

Salivary cortisol was obtained prior to initiation of heelstick procedure, and at 5±0.5 minutes after procedure by gentle insertion in the mouth of a soft applicator (Salimetrics Infant Swab). The samples were stored at -20 degrees, and were analyzed at UAMS.

Outcome measures

Outcome measures
Measure	Sham NESAP With 24% Oral Sucrose n=21 Participants 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. 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. 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).	NESAP With Oral Water n=18 Participants (a) 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. (b) 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: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. 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. Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick.	NESAP With 24% Oral Sucrose n=20 Participants (a) 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. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. 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. 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.	Sham NESAP With Oral Water n=16 Participants 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. 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). 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.
Change in Salivary Cortisol After Heel Stick	36.6 ng/ml Standard Deviation 28.9	41.7 ng/ml Standard Deviation 26	58.5 ng/ml Standard Deviation 22	56.3 ng/ml Standard Deviation 35.7

SECONDARY outcome

Timeframe: Baseline, 20 minutes +/- 5 minutes

Population: Newborn infants

Changes in Heart Rate Variability (HRV) were evaluated using the DL 900 monitor with 3-channel output with 5 leads. Premature infant leads from Braemar, Incorporated, were used with the DL 900 monitor. Leads were applied to the infant's chest before initiation of the TENS unit and the heel stick. The DL300 Holter Monitor will started recording HRV within 10 minutes of TENS unit initiation and the heel stick procedure and continued recording during the procedure and for 2 minutes afterwards.

Outcome measures

Outcome measures
Measure	Sham NESAP With 24% Oral Sucrose n=37 Participants 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. 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. 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).	NESAP With Oral Water n=38 Participants (a) 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. (b) 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: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. 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. Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick.	NESAP With 24% Oral Sucrose n=40 Participants (a) 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. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. 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. 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.	Sham NESAP With Oral Water n=39 Participants 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. 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). 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.
Change in Heart Rate Variability During Heel Stick	1.4 LF/HF ratio Standard Deviation 1.2	1.5 LF/HF ratio Standard Deviation 2	1.3 LF/HF ratio Standard Deviation 1.2	1.3 LF/HF ratio Standard Deviation 1.4

SECONDARY outcome

Timeframe: 10 minutes

(a) Any crying after initiation of TENS unit was noted. If the PIPP scores increased by 4 points from baseline, the TENS unit would have been turned off and the infant withdrawn from the study (safety outcome).

Outcome measures

Outcome measures
Measure	Sham NESAP With 24% Oral Sucrose n=37 Participants 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. 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. 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).	NESAP With Oral Water n=37 Participants (a) 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. (b) 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: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. 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. Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick.	NESAP With 24% Oral Sucrose n=40 Participants (a) 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. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. 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. 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.	Sham NESAP With Oral Water n=39 Participants 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. 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). 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.
Duration of Crying After TENS Unit Was Initiated But Before Heel Stick.	0 seconds Standard Deviation 0	0 seconds Standard Deviation 0	0 seconds Standard Deviation 0	0 seconds Standard Deviation 0

SECONDARY outcome

Timeframe: 5 minutes +/- 2 minutes

Population: Newborn infants during heel stick procedure, crying timed in seconds

Any crying during the heel stick procedure was timed in seconds.

Outcome measures

Outcome measures
Measure	Sham NESAP With 24% Oral Sucrose n=37 Participants 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. 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. 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).	NESAP With Oral Water n=37 Participants (a) 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. (b) 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: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. 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. Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick.	NESAP With 24% Oral Sucrose n=40 Participants (a) 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. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. 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. 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.	Sham NESAP With Oral Water n=39 Participants 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. 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). 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.
Duration of Crying During Heel Stick	0.43 seconds Standard Deviation 1.7	32 seconds Standard Deviation 59.8	7.28 seconds Standard Deviation 26.9	23.7 seconds Standard Deviation 57.8

Adverse Events

Sham NESAP With 24% Oral Sucrose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NESAP With Oral Water

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NESAP With 24% Oral Sucrose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham NESAP With Oral Water

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard W. Hall, professor of pediatrics, co-director of neonatal intensive care unit

University of Arkansas for Medical Sciences

Phone: 501-680-7894

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place