Acupuncture for procedural pain in newborn infants.

rationaleProcedural pain management in newborns, particularly those in neonatal intensive care units (NICUs), presents challenges due to limited safe and effective options. Acupuncture, a Traditional Chinese Medicine practice, has emerged as a potential alternative for pain relief in this population.

objectivesTo assess the benefits and harms of acupuncture in newborn infants undergoing painful procedures. SEARCH

methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, and clinical trial registries up to August 2023. We checked the references of included studies and related systematic reviews. ELIGIBILITY CRITERIA: We included parallel and cross-over randomized controlled trials (RCTs) comparing acupuncture with no treatment or sham treatment; any non-pharmacological treatment; any pharmacological treatment; or one type of acupuncture compared to another type of acupuncture. OUTCOMES: Our outcomes were: pain scores; harms; parental, family, and caregiver satisfaction with the intervention; use of additional pharmacological intervention for pain relief; episodes of bradycardia/apnea/desaturation; neonatal mortality; mortality during initial hospitalization; intraventricular hemorrhage; late-onset sepsis; duration of hospital stay; major neurodevelopmental disability. RISK OF BIAS: We used Cochrane's RoB 1 tool for RCTs. SYNTHESIS

methodsWe conducted meta-analyses using fixed-effect models to calculate risk ratios (RR) and risk differences (RD) with 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) or standardized mean difference (SMD, when combining different pain scales) and standard deviation for continuous outcomes. We summarized the certainty of evidence according to the GRADE approach. INCLUDED STUDIES: We included 11 RCTs enrolling 852 infants. Five studies compared acupuncture to no treatment or sham treatment; four studies to non-pharmacological treatment (oral sucrose or glucose); and two studies compared acupuncture to other types of Traditional Chinese Medicine treatments, which we refer to as 'type B acupuncture,' such as foot massage or reflexology. No studies compared acupuncture to any pharmacological treatment. We identified four ongoing studies. SYNTHESIS OF

resultsWe have listed outcomes reported in at least one study. Acupuncture compared to no treatment or sham treatment Acupuncture may reduce pain assessed during the procedure with any validated scale compared to no intervention (SMD -0.56, 95% CI -0.75 to -0.37; 7 studies, 471 infants; low-certainty evidence). It may result in little to no difference in any harms compared to no intervention (RR 0.35, 95% CI 0.01 to 8.31; 2 studies, 138 infants; low-certainty evidence). Acupuncture compared to any non-pharmacological treatment The evidence is very uncertain about the effect of acupuncture on pain assessed with a validated scale during the procedure compared to non-pharmacological intervention (SMD 0.29, 95% CI 0.04 to 0.54; 4 studies, 267 infants; very low-certainty evidence). Acupuncture may result in little to no difference in any harms compared to non-pharmacological treatment (RR not estimable, RD 0.00, 95% CI -0.03 to 0.03; 3 studies, 247 infants; low-certainty evidence). Acupuncture type A (e.g. penetration of the skin with a needle) compared to acupuncture type B (e.g. foot massage or reflexology) The evidence is very uncertain about the effect of acupressure on pain assessed with any validated scale during the procedure compared to foot massage (SMD 0.05, 95% CI -0.26 to 0.36; 2 studies, 163 infants; very low-certainty evidence). AUTHORS'

conclusionsAcupuncture may reduce pain assessed with different scales during the procedure, with little to no difference in any harms, when compared to no intervention. The evidence is very uncertain about the effect of acupuncture on pain assessed with different scales during the procedure when compared to any non-pharmacological treatment; acupuncture may result in little to no difference in any harms. The evidence is very uncertain about the effect of acupressure on pain assessed during the procedure when compared to foot massage or reflexology.

fundingThis Cochrane review had no dedicated funding. REGISTRATION: Protocol (2023): doi.org/10.1002/14651858.CD015894.