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

Gan KML 1 , Oei JL 2 , Quah-Smith I 2 , Kamar AA 3 , Lordudass AAD 3 , Liem KD 4 Show all authors , Lindrea KB 5 , Daly M 5 , Gaunker N 5 , Mangat AK 6 , Yaskina M 7 , Schmölzer GM 6

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 Neonatology Unit, University of Malaya Medical Centre, Kuala Lumpur, Malaysia
  • 4 Department of Neonatology, Radboudumc Amalia Children's Hospital, Nijmegen, Netherlands
  • 5 Department of Newborn Care, The Royal Hospital for Women, Randwick, NSW, Australia
  • 6 Neonatal Research Unit, Centre for the Studies of Asphyxia and Resuscitation, Royal Alexandra Hospital, Edmonton, AB, Canada
  • 7 Women and Children's Health Research Institute (WCHRI), University of Alberta, Edmonton, AB, Canada
Front Pediatr, 2020;8:615008.
PMID: 33425820 DOI: 10.3389/fped.2020.615008

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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