Clinical trial NCT01800318: Does Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) Reduce Heelstick Pain in Infants?
Official title: Does Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) Reduce Heelstick Pain in Infants?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: NESAP
sucrose
pain
infants
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2013-02-27
Enrollment: 162
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes From Baseline Premature Infant Pain Profile (PIPP) Score to Average PIPP Score During Heel Stick and Squeeze.
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..
Secondary outcomes:
measure: Change in Salivary Cortisol After Heel Stick
timeFrame: Baseline and 5±0.5 minutes after heel stick
measure: Change in Heart Rate Variability During Heel Stick
timeFrame: Baseline, 20 minutes +/- 5 minutes
measure: Duration of Crying After TENS Unit Was Initiated But Before Heel Stick.
timeFrame: 10 minutes
measure: Duration of Crying During Heel Stick
timeFrame: 5 minutes +/- 2 minutes
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: University of Arkansas
name: Richard W Hall, M.D.
role: PRINCIPAL_INVESTIGATOR
References: