Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants

Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants: an Open-label, Randomized-controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03268148

Enrollment

123

Registered

2017-08-31

Start date

2017-08-01

Completion date

2019-12-31

Last updated

2020-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural Pain

Keywords

neonates, pain, low level laser

Brief summary

Neonates undergo several painful procedures and these pain experiences can alter clinical outcome and behavior. The investigators aim to investigate the analgesic effect of low level laser for procedural pain during heel lancing of term neonates.

Detailed description

This open-label, randomized controlled trial involves 130 term newborn infants (gestational ages between 37 weeks to 42 weeks) who need heel lancing for newborn screening. Subjects are randomly assigned to low level laser group or breast milk group. Subjects in breast milk group are given 5ml expressed breast milk by mouth using a syringe tube inserted to the participant's oral cavity over a 2-minute period. LaserPen is applied to the local point for 20 seconds where heel-lancing will be performed in the low level laser group. Then heel lancing is performed and two observers who are blinded to the intervention record the physiological (heart rate and oxygen saturation) and behavioral parameters (duration of crying and modified neonatal facial coding scores) following the procedure. Heart rate variation of participants is record by CheckMyHeart ECG monitor. The salivary swab method is used to detect the infant's salivary cortisol and amylase level as biomarker for stress evaluation. During the study course, digital cameras continuously record participants' behavior. Independent t-test, chi-squared test and one way ANOVA are used for statistical analysis.

Interventions

DEVICELaserPen

low level laser is used before heel-lancing for newborn screening

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Masking description

Two independent assessors blinded to intervention read the video, and then record vital signs and pain score. The videos are cut from heel-lancing to the end so that the assessors do not know whether the neonate receive low level laser or breast milk.

Intervention model description

low level laser group and breast milk group

Eligibility

Sex/Gender

ALL

Age

2 Days to 4 Days

Healthy volunteers

Yes

Inclusion criteria

* healthy fullterm neonates (37-42 gestational age) * Apgar score \>= 7 * will receive newborn screening

Exclusion criteria

* \>42 or \< 37 gestational age * perinatal asphyxia * major malformations or any other disease that need intensive care * drug withdrawal received previous treatment

Design outcomes

Primary

Measure	Time frame	Description
pain assessment	immediately after heel-lancing	latency of first cry, crying time, squeezing time, neonatal facial coding system(NFCS), Neonatal Pain, Agitation and Sedation Scale (NPASS)

Secondary

Measure	Time frame	Description
stress biomarker	baseline, immediately after heel-lancing, 20 minutes after heel-lancing	The salivary swab method is used to detect the infant's salivary cortisol and amylase level at 3 time point.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026