Surya Hospital, Mumbai, Maharashtra, India.
The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA.
J Perinatol. 2020 Jun;40(6):881-887. doi: 10.1038/s41372-020-0608-2. Epub 2020 Feb 13.
To study the efficacy of intranasal fentanyl as an adjunct for pain management during screening for retinopathy of prematurity (ROP) in preterm infants.
In this single center, double blinded, randomized controlled trial, preterm neonates between 30 and 34 weeks postmenstrual age received either intranasal fentanyl (2 mcg/kg) or intranasal normal saline through a mucosal atomization device 5 min prior to the first ROP-screening examination. Both the groups received standard pain relief strategies (oral sucrose, 0.5% proparacaine eye drops and physical containment). The primary outcome was premature infant pain profile-revised (PIPP-R) score during the screening.
A total of 111 infants were enrolled. PIPP-R score during the retinal examination was significantly lower in the fentanyl group (8.3 versus 11.5, mean difference: 3.2 (2.46-4.06), P < 0.001). There was no significant difference in the incidence of adverse effects.
Intranasal fentanyl significantly reduced the pain associated with retinal examination without increasing the risk of respiratory depression. Large RCTs are required to verify the efficacy and safety of intranasal fentanyl for acute procedural pain in neonates.
CTRI/2017/12/011016.
研究鼻内芬太尼在早产儿视网膜病变（ROP）筛查期间作为疼痛管理辅助药物的疗效。
在这项单中心、双盲、随机对照试验中，30 至 34 周龄的早产儿在首次 ROP 筛查检查前 5 分钟通过黏膜雾化器接受鼻内芬太尼（2 mcg/kg）或鼻内生理盐水。两组均接受标准止痛策略（口服蔗糖、0.5%丙泊酚滴眼液和物理固定）。主要结局是筛查期间早产儿疼痛评估修订版（PIPP-R）评分。
共有 111 名婴儿入组。芬太尼组视网膜检查期间的 PIPP-R 评分显著降低（8.3 分比 11.5 分，平均差异：3.2（2.46-4.06），P<0.001）。不良反应发生率无显著差异。
鼻内芬太尼可显著减轻视网膜检查相关疼痛，而不增加呼吸抑制的风险。需要进行大型 RCT 以验证鼻内芬太尼在新生儿急性操作疼痛中的疗效和安全性。
CTRI/2017/12/011016。
