Laser acupuncture versus oral glucose administration for pain prevention in term neonates: an observer-blinded non-inferiority randomized controlled clinical trial

Abstract

Background: Neonates undergoing intensive care are routinely submitted to minor painful procedures such as heel lances. Pharmacological treatment is limited in neonatal care and not recommended for minor painful interventions. Hence, non-pharmacological acute pain management is an important subject. Acupuncture could be a new strategy for neonatal pain prevention. Accordingly, the aim of the present study was to investigate whether laser acupuncture is non-inferior to oral sweet solutions in pain prevention. Methods: In total, 96 healthy term neonates were randomly assigned to receive either laser acupuncture with 10 mW at LI4 bilaterally (AG, acupuncture group) or 30% oral glucose solution (GG, glucose group) before heel lance for metabolic screening. The primary outcome was the difference in premature infant pain profile (PIPP) score between groups in a non-inferiority concept. Secondary outcomes were changes in heart rate and crying time. Results: Median (interquartile range) PIPP scores were comparable in the AG and GG (12 (10–14) vs 12 (9–14), p = 0.981). Nevertheless, the 95% confidence interval (CI) of location shift exceeded the predefined margin for non-inferiority of 1 (95% CI: –1.000006 to 1.000059). Heart rate was found to be significantly lower after intervention (p = 0.048) and after heel lance (p = 0.015) in the AG versus GG. There was no difference in crying time between groups (p = 0.890). Conclusion: Laser acupuncture was not shown to be non-inferior to an oral glucose solution, possibly due to the higher than expected variability in PIPP scores within the studied groups. Future neonatal laser acupuncture studies for pain prevention with higher sample sizes are therefore warranted.

Effectiveness of technology-based interventions compared with other non-pharmacological interventions for relieving procedural pain in hospitalized neonates: a systematic review

“…Regarding the status of the neonates, 3 studies included healthy, full-term neonates 49,51,53 ; 1 study described sick, full-term neonates 55 ; 1 study involved sick, full-term neonates, and neonates in the mild preterm category (born 35 to 40+6 weeks of gestational age) 54 ; and 5 studies described preterm infants (born before 37 weeks of gestational age) 47,48,50,52,56 . Of the studies included in this review, 6 were performed in a neonatal intensive care unit, 47,48,50,52,55,56 1 was performed in intermediate/transition care nursery, 54 and 3 studies did not give a more detailed description of the nature of the hospital ward 49,51,53 . The studies included sick neonates 47,48,50–52,54–56 but excluded participants with critical illnesses.…”

“…Specifically, Williams et al 52 measured pain outcomes using heart rate variability (HRV) and changes in HR, while Ranger et al 50 assessed pain based on the cerebral tissue saturation index (TSI), as measured by near infrared spectroscopy. An additional 5 studies reported pain outcomes according to changes in physiological indicators in addition to the results of validated pain assessment scales; more specifically, these studies assessed pain based on changes in HR 48,51,55,56 and oxygen saturation. 47,51,55,56 Behavioral indicators were used to measure pain outcomes in 2 studies, 51,53 which both used crying time as the outcome variable.…”

“…An additional 5 studies reported pain outcomes according to changes in physiological indicators in addition to the results of validated pain assessment scales; more specifically, these studies assessed pain based on changes in HR 48,51,55,56 and oxygen saturation. 47,51,55,56 Behavioral indicators were used to measure pain outcomes in 2 studies, 51,53 which both used crying time as the outcome variable. In the study by Abbasoglu et al, 53 both crying time and a pain meter were used to measure pain, whereas Stadler et al 51 combined total crying time with physiological indicators to measure pain among neonates.…”

“…Surprisingly, some of the studies did not reveal whether true randomization was used when assigning participants to the treatment group (Q1), 47,54,55 as well as whether allocation to treatment groups was concealed (Q2). 47,51,55,56 This includes the study by Chirico et al, 47 which received the lowest methodological quality score.…”

“…53,56 The studies were published between 2010 and 2021. A majority of these studies (ie, 9 out of 10) were single-center studies that were conducted in 1 ward of 1 hospital, 47,48,[50][51][52][53][54][55][56] while 1 study involved 2 sites in the USA. 49 The characteristics of these studies are shown in Appendix IV.…”