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, 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

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.

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.

Copyright © 2020 Gan, Oei, Quah-Smith, Kamar, Lordudass, Liem, Lindrea, Daly, Gaunker, Mangat, Yaskina and Schmölzer.

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.

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
    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
    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
    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
    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
    1. Lee KA, Ganta N, Horton JR, Chai E. Evidence for neurotoxicity due to morphine or hydromorphone use in renal impairment: a systematic review. J Palliat Med. (2016) 19:1179–87. 10.1089/jpm.2016.0101
    1. Bembich S, Cont G, Causin E, Paviotti G, Marzari P, Demarini S. Infant analgesia with a combination of breast milk, glucose, or maternal holding. Pediatrics. (2018) 142:e20173416 10.1542/peds.2017-3416
    1. Chen KL, Lindrea KB, Quah-Smith I, Schmölzer GM, Daly M, Schindler T, et al. . Magnetic noninvasive acupuncture for infant comfort (MAGNIFIC) - a single-blinded randomised controlled pilot trial. Acta Paediatr. (2017) 106:1780–6. 10.1111/apa.14002
    1. Niemtzow RC. Battlefield acupuncture. Med Acupuncture. (2007) 19:225–8. 10.1089/acu.2007.0603
    1. Strittmatter B. Ear Acupuncture : A Precise Pocket Atlas, Based on the Works of Nogier/Bahr. 2nd edn. Stuttgart: Thieme Publishing Group; (2011) 440. p. 10.1055/b-0034-75134
    1. Gibbins S, Stevens BJ, Yamada J, Dionne K, Campbell-Yeo M, Lee G, et al. . Validation of the Premature Infant Pain Profile-Revised (PIPP-R). Early Hum Dev. (2014) 90:189–93. 10.1016/j.earlhumdev.2014.01.005
    1. Disher T, Cameron C, Mitra S, Cathcart K, Campbell-Yeo M. Pain-relieving interventions for retinopathy of prematurity: a meta-analysis. Pediatrics. (2018). 142:e20180401. 10.1542/peds.2018-0401
    1. Hartley C, Moultrie F, Hoskin A, Green G, Monk V, Bell JL, et al. . Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial. Lancet. (2018) 392:2595–605. 10.1016/S0140-6736(18)31813-0
    1. Chen KL, Quah-Smith I, Schmölzer GM, Niemtzow R, Oei JL. Acupuncture in the neonatal intensive care unit-using ancient medicine to help today's babies: a review. J Perinatol. (2017) 37:749–56. 10.1038/jp.2016.227
    1. Abbasoglu A, Cabioglu MT, Tugcu AU, Yapakci E, Tekindal MA, Tarcan A. Laser acupuncture before heel lancing for pain management in healthy term newborns: a randomised controlled trial. Acupunct Med. (2015) 33:445–50. 10.1136/acupmed-2015-010765
    1. Jackson HJ, Lopez C, Miller S, Engelhardt B. A scoping review of acupuncture as a potential intervention for neonatal abstinence syndrome. Med Acupunct. (2019) 31:69–84. 10.1089/acu.2018.1323
    1. Carbajal R, Lenclen R, Jugie M, Paupe A, Barton BA, Anand KJ. Morphine does not provide adequate analgesia for acute procedural pain among preterm neonates. Pediatrics. (2005) 115:1494–500. 10.1542/peds.2004-1425
    1. Grabska J, Walden P, Lerer T, Kelly C, Hussain N, Donovan T, et al. . Can oral sucrose reduce the pain and distress associated with screening for retinopathy of prematurity? J Perinatol. (2005) 25:33–5. 10.1038/sj.jp.7211199
    1. Colbert AP, Cleaver J, Brown KA, Harling N, Hwang Y, Schiffke HC, et al. . Magnets applied to acupuncture points as therapy - a literature review. Acupunct Med. (2008) 26:160–70. 10.1136/aim.26.3.160
    1. Niemtzow RC, Litscher G, Burns SM, Helms JM. Battlefield acupuncture: update. Med Acupuncture. (2009) 21:43–6. 10.1089/acu.2009.0666
    1. Frangos E, Ellrich J, Komisaruk BR. Non-invasive access to the vagus nerve central projections via electrical stimulation of the external ear: fMRI Evidence in humans. Brain Stimul. (2015) 8:624–36. 10.1016/j.brs.2014.11.018
    1. Mercante B, Ginatempo F, Manca A, Melis F, Enrico P, Deriu F. Anatomo-physiologic basis for auricular stimulation. Med Acupunct. (2018) 30:141–50. 10.1089/acu.2017.1254
    1. He W, Wang X, Shi H, et al. . Auricular acupuncture and vagal regulation. Evid Based Complement Alternat Med. (2012) 2012:786839. 10.1155/2012/786839
    1. Haker E, Egekvist H, Bjerring P. Effect of sensory stimulation (acupuncture) on sympathetic and parasympathetic activities in healthy subjects. J Auton Nerv Syst. (2000) 79:52–9. 10.1016/S0165-1838(99)00090-9
    1. Murray AR, Atkinson L, Mahadi MK, Deuchars SA, Deuchars J. The strange case of the ear and the heart: the auricular vagus nerve and its influence on cardiac control. Auton Neurosci. (2016) 199:48–53. 10.1016/j.autneu.2016.06.004
    1. Holsti L, Grunau RE, Oberlander TF, Osiovich H. Is it painful or not? Discriminant validity of the Behavioral Indicators of Infant Pain (BIIP) scale. Clin J Pain. (2008) 24:83–8. 10.1097/AJP.0b013e318158c5e5
    1. Sator-Katzenschlager SM, Szeles JC, Scharbert G, Michalek-Sauberer A, Kober A, Heinze G, et al. . Electrical stimulation of auricular acupuncture points is more effective than conventional manual auricular acupuncture in chronic cervical pain: a pilot study. Anesth Analg. (2003) 97:1469–73. 10.1213/01.ANE.0000082246.67897.0B
    1. McLean MJ, Holcomb RR, Wamil AW, Pickett JD, Cavopol AV. Blockade of sensory neuron action potentials by a static magnetic field in the 10 mT range. Bioelectromagnetics. (1995) 16:20–32. 10.1002/bem.2250160108
    1. Abbasoglu A, Cabioglu MT, Tugcu AU, Ince DA, Tekindal MA, Ecevit A, et al. . Acupressure at BL60 and K3 points before heel lancing in preterm infants. Explore. (2015) 11:363–6. 10.1016/j.explore.2015.07.005

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner