Ku L C, Simmons C, Smith P B, Greenberg R G, Fisher K, Hornik C D, Cotten C Michael, Goldberg R N, Bidegain M
Department of Pediatrics, Division of Neonatal-Perinatal Medicine, Duke University Medical Center, Durham, NC, USA.
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
J Neonatal Perinatal Med. 2019;12(2):143-148. doi: 10.3233/NPM-17149.
The intranasal route is a minimally invasive method for rapidly delivering midazolam and fentanyl to provide short-term analgesia and sedation in infants. However, intranasal use of midazolam and fentanyl is not labeled for infants and safety data are sparse. The objective of this study is to evaluate the safety of intranasal midazolam and intranasal fentanyl in infants admitted to the Neonatal Intensive Care Unit (NICU).
We retrospectively identified all infants receiving intranasal midazolam or fentanyl in the NICU from 2009 to 2015. We recorded indication for use and vital signs and determined the proportion of infants experiencing the following adverse events: death within 24 hours, hypotension, bradycardia, worsening respiratory status, and chest wall rigidity. Vital signs 4 hours before and after each dose were compared using the Wilcoxon signed-rank test.
We identified 17 infants (gestational ages 23- 41 weeks) receiving 25 intranasal doses. None of the infants died or developed hypotension, bradycardia, or chest wall rigidity. Intranasal delivery was most commonly used for sedation during magnetic resonance imaging studies. Other indications include analgesia or sedation for retinopathy of prematurity surgery, intubation, and peripherally inserted central catheter placement. One infant receiving intranasal midazolam experienced worsening respiratory status. Vital signs before and after dosing were not significantly different.
Intranasal midazolam and fentanyl use in term and preterm infants appeared safe and well-tolerated in this small cohort of infants. Larger, prospective studies evaluating the safety and efficacy of intranasal midazolam and fentanyl use in infants are warranted.
鼻内给药途径是一种微创方法，可快速给予咪达唑仑和芬太尼，为婴儿提供短期镇痛和镇静。然而，咪达唑仑和芬太尼的鼻内使用未被批准用于婴儿，且安全性数据稀少。本研究的目的是评估新生儿重症监护病房（NICU）中婴儿使用鼻内咪达唑仑和鼻内芬太尼的安全性。
我们回顾性确定了2009年至2015年在NICU接受鼻内咪达唑仑或芬太尼治疗的所有婴儿。我们记录了使用指征和生命体征，并确定了发生以下不良事件的婴儿比例：24小时内死亡、低血压、心动过缓、呼吸状况恶化和胸壁僵硬。使用Wilcoxon符号秩检验比较每次给药前后4小时的生命体征。
我们确定了17名婴儿（胎龄23 - 41周）接受了25次鼻内给药。没有婴儿死亡或出现低血压、心动过缓或胸壁僵硬。鼻内给药最常用于磁共振成像检查期间的镇静。其他指征包括用于早产儿视网膜病变手术、插管和外周静脉穿刺中心静脉置管的镇痛或镇静。一名接受鼻内咪达唑仑治疗的婴儿呼吸状况恶化。给药前后的生命体征无显著差异。
在这一小群婴儿中，足月和早产婴儿使用鼻内咪达唑仑和芬太尼似乎是安全且耐受性良好的。有必要进行更大规模的前瞻性研究，以评估婴儿使用鼻内咪达唑仑和芬太尼的安全性和有效性。
