Kayki Gozdem, Yalcin Nadir, Celik Hasan Tolga, Yigit Sule
Department of Pediatrics, Division of Neonatology, Hacettepe University Faculty of Medicine, Ankara, Turkey
Department of Clinical Pharmacy, Hacettepe University, Faculty of Pharmacy, Ankara, Turkey.
BMJ Paediatr Open. 2025 Mar 18;9(1):e003004. doi: 10.1136/bmjpo-2024-003004.
Dexmedetomidine is an alpha-2 adrenergic agonist with sedative, anxiolytic and analgesic effects. Its use in neonatal intensive care units (NICUs) has been increasing in the last decade. The aim of this study was to assess the safety profile of dexmedetomidine and to identify specific trends in its use over time.
In this retrospective observational study, data were collected on all patients who received continuous infusion of dexmedetomidine in a level IV NICU in Turkey between 2018 and 2023. Demographic characteristics were compared between preterm and term infants using the Mann-Whitney U test. Differences in adverse effects between term and preterm infants, as well as between lower and higher doses, were analysed using the χ test. Regression analysis was conducted to identify factors influencing adverse effects.
A total of 383 patients were included. The participants had a median (IQR) gestational age of 37 (35-38) weeks with a median (IQR) birth weight of 2700 (2140-3270) grams and the median (IQR) postmenstrual age at the time of dexmedetomidine initiation was 38 (36-40) weeks. The most common indication for use was pain control following surgery and/or interventional procedures (81.5%). There was a statistically significant increase in initial doses (p<0.001) and treatment duration (p=0.009). Adverse drug reactions (ADRs) were observed in 5% of cases, mostly bradycardia (50%) and ADRs did not correlate with the dose (0.80), treatment duration (0.96) or gestational age (p=0.93).
Our data and experiences demonstrated a significant increase in the dose and duration of dexmedetomidine use in the NICU over the years. Additionally, the findings have suggested that higher doses and treatment duration do not result in an increase in ADRs during the acute period.
右美托咪定是一种α-2肾上腺素能激动剂,具有镇静、抗焦虑和镇痛作用。在过去十年中,其在新生儿重症监护病房(NICU)的使用一直在增加。本研究的目的是评估右美托咪定的安全性,并确定其随时间推移的具体使用趋势。
在这项回顾性观察研究中,收集了2018年至2023年期间在土耳其一家四级NICU接受右美托咪定持续输注的所有患者的数据。使用Mann-Whitney U检验比较早产儿和足月儿的人口统计学特征。使用χ检验分析足月儿和早产儿以及低剂量和高剂量之间不良反应的差异。进行回归分析以确定影响不良反应的因素。
共纳入383例患者。参与者的中位(IQR)胎龄为37(35-38)周,中位(IQR)出生体重为2700(2140-3270)克,开始使用右美托咪定的中位(IQR)月经后年龄为38(36-40)周。最常见的使用指征是手术和/或介入操作后的疼痛控制(81.5%)。初始剂量(p<0.001)和治疗持续时间(p=0.009)有统计学显著增加。5%的病例观察到药物不良反应(ADR),主要是心动过缓(50%),且ADR与剂量(0.80)、治疗持续时间(0.96)或胎龄(p=0.93)无关。
我们的数据和经验表明,多年来NICU中右美托咪定的使用剂量和持续时间显著增加。此外,研究结果表明,在急性期,更高的剂量和治疗持续时间不会导致ADR增加。