Effect of Magnetic Auricular Acupuncture on Pain during Ophthalmic Examination of the Newborn: A Multicenter, Triple-Blinded, Randomized Controlled Study

Abstract

Introduction: Newborn ophthalmologicexamination is a painful procedure. Untreated pain experiences in infants have both short-term and long-term consequences, and pain control is essential. Unfortunately, non-pharmacological pain strategies are usually ineffective for complex and protracted procedures, whereas many pharmacologic agents have adverse effects. Magnetic auricular acupuncture (MAA) is a new method of pain relief that is potentially safe and effective. The objective of this study was to conduct a large definitive triple blinded randomized controlled trial of MAA for reducing pain in neonates undergoing ophthalmologic examination. The trial was registered at ClinicalTrials.gov (ChiCTR1900027474). The registration was completed on November 14, 2019. Methods: This was a multi-centerrandomized controlled trial conducted at 16 tertiary hospitals in the People’s Republic of China. Infants were eligible for participation if they were born at 26 to 42 weeks gestational age (GA) and admitted to participating NICUs during the study enrollment period, and scheduled to receive an eye examination for the first time at <44 weeks’ corrected GA. Written informed consent was obtained from parents. Infants who were critically ill, dying or receiving sedatives were excluded. Infants randomized to the intervention (MAA) group receivedmagnetic stickers applied prior to the ophthalmologic procedure. Control group infants received placebo stickers with the magnets removed. We compared the primary outcome of Premature Infant Pain Profile (PIPP) score during the procedure between the two groups. Results: A total of 408 patients were randomized, but 14 patients in each of the placebo and intervention groups did not receive ophthalmologic examination; leaving 190 patients in control group and 190 in intervention group. Infant characteristics were similar in the two groups,mean PIPP scores during eye exam were significantly lower in the intervention group compared to the control group (median (IQR): 10.00 (5.00,13.00) v 12.00 (7.00,14.00), p = 0.038). Conclusions：MAA may offer an alternate to current non-pharmacologic and pharmacologic interventions to alleviate neonatal pain. Future studies should assess the long term outcomes.