RESUMO
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.
RESUMO
AIM: To determine the safety and feasibility of auricular noninvasive magnetic acupuncture (MA) to decrease infant pain during heel pricks. METHODS: Infants requiring heel pricks for blood collection were randomised to either MA (n = 21) or placebo (P) (n = 19) after parental informed consent. MA or placebo stickers were placed on both ears according to the Battlefield Protocol by an unblinded investigator and left on for 3 days. Pain was assessed with the Premature Infant Pain Profile (PIPP) by blinded clinicians. RESULTS: Mean gestation (MA:34.1, P:34.4 weeks) and age of infants (MA:5.3, P:4.5 days) were similar as were mean (SD) pre (MA:1.7(1.4), P:2.1(1.9)) and post (MA:1.6(1.4), P: 2.1(1.7)) heel prick PIPP scores. PIPP scores were significantly lower in MA infants during heel pricks (MA:5.9(3.7), P: 8.3(4.7), p = 0.04). One-way ANCOVA modelling showed that MA was significantly associated with lower PIPP scores after controlling for analgesic use (p = 0.043). No differences in heart rate, oxygen saturation, analgesic use or adverse effects (e.g. local skin reactions) noted. CONCLUSION: This pilot study shows that auricular MA is feasible in neonates and may reduce PIPP scores during heel pricks. Further study is required to determine the impact of MA on other painful or stressful conditions and on neurodevelopment.
