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

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

Kimberly M L Gan  1   2 , Ju-Lee Oei  2   3 , Im Quah-Smith  2   4 , Azanna A Kamar  5 , Alexis A D Lordudass  5 , Kian D Liem  6 , Kwee Bee Lindrea  3 , Mary Daly  3 , Nilima Gaunker  3 , Avneet K Mangat  7   8 , Maryna Yaskina  9 , Georg M Schmölzer  7   8
Affiliations

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

Kimberly M L Gan et al. Front Pediatr. .

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.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
(A) Modified Battlefield acupuncture protocol. The magnets were placed sequentially in the following order: (1) Cingulate Gyrus, (2) Thalamus, (3) Shenmen, (4) Cranial Nerve-5 (Ophthalmic branch).9,10 (B) (1) The placebo sticker (2) magnet sticker (3) concealment by white correction fluid.
Figure 2
Figure 2
Consort flow diagram.
See this image and copyright information in PMC

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References

    1. Bauchner H, May A, Coates E. Use of analgesic agents for invasive medical procedures in pediatric and neonatal intensive care units. J Pediatr. (1992) 121:647–9. 10.1016/S0022-3476(05)81164-3 - DOI - PubMed
    1. Courtois E, Cimerman P, Dubuche V, Goiset MF, Orfèvre C, Lagarde A, et al. . The burden of venipuncture pain in neonatal intensive care units: EPIPPAIN 2, a prospective observational study. Int J Nurs Stud. (2016) 57:48–59. 10.1016/j.ijnurstu.2016.01.014 - DOI - PubMed
    1. Anand KJ, Hickey PR. Pain and its effects in the human neonate and fetus. N Engl J Med. (1987) 317:1321–9. 10.1056/NEJM198711193172105 - DOI - PubMed
    1. Ranger M, Chau CMY, Garg A, Woodward TS, Beg MF, Bjornson B, et al. . Neonatal pain-related stress predicts cortical thickness at age 7 years in children born very preterm. PLOS ONE. (2013) 8:e76702. 10.1371/journal.pone.0076702 - DOI - PMC - PubMed
    1. Hall RW, Kronsberg SS, Barton BA, Kaiser JR, Anand KJ; NEOPAIN Trial Investigators Group. Morphine, hypotension, and adverse outcomes among preterm neonates: who's to blame? Secondary results from the NEOPAIN trial. Pediatrics. (2005). 115:1351–9. 10.1542/peds.2004-1398 - DOI - PubMed

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