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

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

doi:10.3389/fped.2020.615008

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

Front Pediatr. 2020 Dec 23:8:615008. doi: 10.3389/fped.2020.615008. eCollection 2020.

Authors

Kimberly M L Gan^{1

2}, Ju-Lee Oei^{2

3}, Im Quah-Smith^{2

4}, Azanna A Kamar⁵, Alexis A D Lordudass⁵, Kian D Liem⁶, Kwee Bee Lindrea³, Mary Daly³, Nilima Gaunker³, Avneet K Mangat^{7

8}, Maryna Yaskina⁹, Georg M Schmölzer^{7

8}

Affiliations

¹ Faculty of Medicine, University of New South Wales, Kensington, NSW, Australia.
² School of Women's and Children's Health, University of New South Wales, Kensington, NSW, Australia.
³ Department of Newborn Care, The Royal Hospital for Women, Randwick, NSW, Australia.
⁴ Roseville Wellness Group, Roseville, NSW, Australia.
⁵ Neonatology Unit, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.
⁶ Department of Neonatology, Radboudumc Amalia Children's Hospital, Nijmegen, Netherlands.
⁷ Neonatal Research Unit, Centre for the Studies of Asphyxia and Resuscitation, Royal Alexandra Hospital, Edmonton, AB, Canada.
⁸ Department of Paediatrics, University of Alberta, Edmonton, AB, Canada.
⁹ Women and Children's Health Research Institute (WCHRI), University of Alberta, Edmonton, AB, Canada.

Abstract

Background: 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. Methods: Multicentre randomized controlled trial conducted in three hospitals (Australia, Canada, and Malaysia). Eligibility: >32 weeks, ROP exam, not sedated, and parental consent. A total of 100 infants were randomized (1:1) to MAA (n = 50) or placebo (n = 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. ClinicalTrials.gov:NCT03650621. Findings: 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 (p < 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)%, p = 0.05) in MAA infants. No adverse effects. Interpretation: MAA may reduce physiological pain responses during and after ROP exam in preterm infants. Assessment of long-term effects are warranted. Clinical trial registration: www.ClinicalTrials.gov, identifier: NCT03650621.

Keywords: acupunctural analgesia; acupuncture; newborn; pain; retinopathy of prematurity.

Associated data

ClinicalTrials.gov/NCT03650621