AUTHOR=Gan Kimberly M. L. , Oei Ju-Lee , Quah-Smith Im , Kamar Azanna A. , Lordudass Alexis A. D. , Liem Kian D. , Lindrea Kwee Bee , Daly Mary , Gaunker Nilima , Mangat Avneet K. , Yaskina Maryna , Schmölzer Georg M. 

TITLE=Magnetic Non-invasive Auricular Acupuncture During Eye-Exam for Retinopathy of Prematurity in Preterm Infants: A Multicentre Randomized Controlled Trial

JOURNAL=Frontiers in Pediatrics

VOLUME=8

YEAR=2020

URL=https://www.frontiersin.org/journals/pediatrics/articles/10.3389/fped.2020.615008

DOI=10.3389/fped.2020.615008

ISSN=2296-2360

ABSTRACT=<p><bold>Background:</bold> Eye exam for Retinopathy of prematurity (ROP) is a painful procedure and pharmacological analgesia might be ineffective. We hypothesized that magnetic auricular acupuncture (MAA) compared to placebo will decrease pain during ROP exam in preterm infants.</p><p><bold>Methods:</bold> Multicentre randomized controlled trial conducted in three hospitals (Australia, Canada, and Malaysia). Eligibility: &gt;32 weeks, ROP exam, not sedated, and parental consent. A total of 100 infants were randomized (1:1) to MAA (<italic>n</italic> = 50) or placebo (<italic>n</italic> = 50). MAA stickers or placebo were placed on both ears by an unblinded investigator. Pain was assessed using the Premature Infant Pain Profile. Primary analyses were by intention-to-treat. <ext-link ext-link-type="uri" xlink:href="https://ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link>:NCT03650621.</p><p><bold>Findings:</bold> The mean (standard deviation, SD) gestation, birthweight, and postnatal age were (MAA 28(3) vs. placebo 28(2) weeks; MAA 1,057(455) vs. placebo 952(273) g; MAA 7(3) vs. placebo 7(3) weeks. Placebo infants had significantly higher PIPP scores during [mean difference 1.6 points (95%CI 0.1–3.1)] and 1 h mean difference 1.5 points (95%CI 0.7–2.2) after the procedure (<italic>p</italic> &lt; 0.03). Heart rate was lower (173(22) vs. 184(18)/min) and oxygen saturations were higher (93.8(6.2) vs. 91.7(6.1)%, <italic>p</italic> = 0.05) in MAA infants. No adverse effects.</p><p><bold>Interpretation:</bold> MAA may reduce physiological pain responses during and after ROP exam in preterm infants. Assessment of long-term effects are warranted.</p><p><bold>Clinical trial registration</bold>: <ext-link ext-link-type="uri" xlink:href="https://www.ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">www.ClinicalTrials.gov</ext-link>, identifier: NCT03650621.</p>