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

Not Applicable

Completed

• Conditions: Procedural Pain
• Interventions: Device: LaserPen

• Registration Number: NCT03268148
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-31
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan