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

Chang Gung Medical Foundation

Status: Completed

Conditions: Procedural Pain

Treatments: Device: LaserPen

Study type: Interventional

Funder types: Other

Identifiers

NCT03268148

201700474A3C501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 2 to 4 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 2 patient groups

low level laser group

Experimental group

Description:

LaserPen is applied to the local point for 20 seconds where heel-lancing will be performed in the low level laser group.

Treatment:

Device: LaserPen

breast milk group

No Intervention group

Description:

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 before heel-lancing.