N/A
Completed N=162
Does Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) Reduce Heelstick Pain in Infants?
Source: ClinicalTrials.gov NCT01800318 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Changes From Baseline Premature Infant Pain Profile (PIPP) Score to Average PIPP Score During Heel Stick and Squeeze. — 4.0; 5.0; 3.6; 4.9 units on a scale (PIPP score) — p=0.07
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes From Baseline Premature Infant Pain Profile (PIPP) Score to Average PIPP Score During Heel Stick and Squeeze. |
4.0; 5.0; 3.6; 4.9 | 0.07 |
| SECONDARY Change in Salivary Cortisol After Heel Stick |
36.6; 41.7; 58.5; 56.3 | 0.9 |
| SECONDARY Change in Heart Rate Variability During Heel Stick |
1.4; 1.5; 1.3; 1.3 | 0.9 |
| SECONDARY Duration of Crying After TENS Unit Was Initiated But Before Heel Stick. |
0; 0; 0; 0 | — |
| SECONDARY Duration of Crying During Heel Stick |
0.43; 32; 7.28; 23.7 | 0.008 sig |
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.
Data sourced from ClinicalTrials.gov (NCT01800318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.