Department of Neonatology, Institute of Post Graduate Medical, Education & Research and SSKM Hospital, Kolkata 700020, India.
Department of Pharmacology, Institute of Post Graduate Medical, Education & Research and SSKM Hospital, Kolkata 700020, India.
J Trop Pediatr. 2022 Feb 3;68(2). doi: 10.1093/tropej/fmac019.
Currently, there is no consensus regarding analgesic premedication before the surfactant administration by less invasive surfactant application (LISA) procedure. In this randomized controlled trial, we compared the level of comfort of preterm infants receiving fentanyl as analgesic and sedative versus no fentanyl during LISA procedure.
We randomized 34 preterm infants of 28+0-33+6 weeks of gestation with respiratory distress syndrome (RDS) within 6 h of birth to receive either fentanyl (1 μg/kg intravenous) or no premedication during surfactant administration by LISA procedure. Primary objective was to assess the proportion of preterm infants to be comfortable during the procedure [revised premature infant pain profile (R-PIPP) score ≤12] and secondarily complications occurring during the procedure, hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular hemorrhage (IVH) (≥ grade 3), bronchopulmonary dysplasia (BPD) and composite outcome of BPD/mortality.
Proportion of preterm infants with a R-PIPP score ≤12 during LISA was significantly higher in the fentanyl group [15/17 (88.23%) vs. 8/17 (47.05%); p value 0.025]. There were no differences in secondary outcome parameters.
Low-dose fentanyl during LISA procedure resulted in more comfort in preterm infants and without increased complication of both the LISA procedure and fentanyl administration. Further studies are needed to determine the safest and most effective pharmacologic measures to prevent pain and discomfort during LISA.
目前,对于经鼻持续气道正压通气(NCPAP)联合肺表面活性物质应用(LISA)治疗呼吸窘迫综合征(RDS)时,是否需要预先镇痛仍无定论。在本随机对照试验中,我们比较了 LISA 治疗前给予舒芬太尼镇痛镇静与不给予舒芬太尼对早产儿舒适度的影响。
我们将 34 例胎龄 28+0-33+6 周、出生后 6 小时内有 RDS 的早产儿随机分为 LISA 治疗时给予舒芬太尼(1μg/kg 静脉注射)或不给予舒芬太尼的两组。主要观察指标为评估两组早产儿在治疗过程中的舒适度(修订后的早产儿疼痛评分量表(R-PIPP)评分≤12)。次要观察指标为治疗过程中发生的并发症,包括血流动力学显著的动脉导管未闭(hsPDA)、颅内出血(IVH)(≥3 级)、支气管肺发育不良(BPD)和 BPD/死亡率的复合结局。
舒芬太尼组 LISA 治疗时 R-PIPP 评分≤12 的早产儿比例明显高于对照组[15/17(88.23%)比 8/17(47.05%);p 值=0.025]。两组次要结局参数无差异。
LISA 治疗时给予小剂量舒芬太尼可提高早产儿的舒适度,且不会增加 LISA 治疗和舒芬太尼给药的并发症。需要进一步研究确定预防 LISA 治疗期间疼痛和不适的最安全有效的药物措施。