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

Procedural Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268148
• Other study ID #: 201700474A3C501
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Days

Eligibility

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

Related Conditions & MeSH terms

• Pain, Procedural
• Procedural Pain

Intervention

Device:
• LaserPen
low level laser is used before heel-lancing for newborn screening

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Ou-Yang MC, Chen IL, Chen CC, Chung MY, Chen FS, Huang HC. Expressed breast milk for procedural pain in preterm neonates: a randomized, double-blind, placebo-controlled trial. Acta Paediatr. 2013 Jan;102(1):15-21. doi: 10.1111/apa.12045. Epub 2012 Nov 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain assessment	latency of first cry, crying time, squeezing time, neonatal facial coding system(NFCS), Neonatal Pain, Agitation and Sedation Scale (NPASS)	immediately after heel-lancing
Secondary	stress biomarker	The salivary swab method is used to detect the infant's salivary cortisol and amylase level at 3 time point.	baseline, immediately after heel-lancing, 20 minutes after heel-lancing