Clinical trial NCT03268148: Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants
Official title: Analgesic Effect of Low Level Laser for Procedural Pain in Newborn Infants: an Open-label, Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Keywords: neonates
pain
low level laser
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 123
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: low level laser group and breast milk group
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain assessment
timeFrame: immediately after heel-lancing
Secondary outcomes:
measure: stress biomarker
timeFrame: baseline, immediately after heel-lancing, 20 minutes after heel-lancing
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Bei-yu Wu, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.