Behura Sushree Smita, Panda Santosh Kumar, Tripathy Subhrajyoti, Kujur Ipsa, Sahoo Swaranjika, Pradhan Deepti Damayanty
Department of Paediatrics, Kalinga Institute of Medical Sciences, KIIT DU, Bhubaneswar, Odisha, India.
Department of Neonatology, Kalinga Institute of Medical Sciences, KIIT DU, Bhubaneswar, Odisha, 751024, India.
Eur J Clin Pharmacol. 2025 Sep 3. doi: 10.1007/s00228-025-03914-7.
This study aims to compare the analgesic efficacy of oral melatonin with placebo in neonates during venepuncture.
This open-level, pilot randomized controlled trial was conducted in a tertiary care neonatal unit. Sixty eligible, non-sick neonates (gestational age ≥ 34 weeks) scheduled for venepuncture were randomized into the melatonin group (MG, n = 30) and the placebo group (PG, n = 30). MG received oral melatonin (1 mg/kg), and PG received 2 ml of normal saline. Pain intensity was measured by the Premature Infant Pain Profile-Revised (PIPP-R) during the procedure and at 1 min and 2 min post-procedure. Scores were compared between both groups using the Mann-Whitney U test, and the effect size was calculated with the rank-biserial correlation coefficient.
The demographic characteristics were comparable between the two groups. The median (Q1-Q3) PIPP-R score in MG and PG during the procedure was 10 (9-10) and 13 (12-14), respectively, r = 0.8, p < 0.001; at 1 min [3 (2-3) and 5.5 (4-7)], r = 0.69, p < 0.001; and at 2 min [0 (0-0) and 1 (0-2)], r = 0.3, p = 0.003. Melatonin improved autonomic stability during (lower heart rates and higher oxygen saturation) and after venepuncture (higher oxygen saturation). Although procedural facial expressions were similar, fewer neonates in the melatonin group showed pain-related facial cues post-procedure compared to placebo. No significant adverse effect was noted in either group.
Oral melatonin showed autonomic modulation and reduced PIPP-R scores in neonates during venepuncture compared to placebo, with no adverse effects, supporting its use as an analgesic. CLINICAL TRIAL REGISTRY OF INDIA: (CTRI) number- CTRI/2023/07/055046 on dated 11.07.2023.
本研究旨在比较口服褪黑素与安慰剂对新生儿静脉穿刺时的镇痛效果。
本开放性、先导性随机对照试验在一家三级护理新生儿病房进行。60例计划进行静脉穿刺的符合条件的非患病新生儿（胎龄≥34周）被随机分为褪黑素组（MG，n = 30）和安慰剂组（PG，n = 30）。MG组口服褪黑素（1 mg/kg），PG组接受2 ml生理盐水。在操作过程中以及操作后1分钟和2分钟，通过修订的早产儿疼痛量表（PIPP-R）测量疼痛强度。两组间的得分比较采用曼-惠特尼U检验，并使用等级双列相关系数计算效应量。
两组的人口统计学特征具有可比性。操作过程中MG组和PG组的PIPP-R得分中位数（Q1-Q3）分别为10（9-10）和13（12-14），r = 0.8，p < 0.001；1分钟时[3（2-3）和5.5（4-7）]，r = 0.69，p < 0.001；2分钟时[0（0-0）和1（0-2）]，r = 0.3，p = 0.003。褪黑素在静脉穿刺期间（较低心率和较高血氧饱和度）和穿刺后（较高血氧饱和度）改善了自主稳定性。尽管操作过程中的面部表情相似，但与安慰剂组相比，褪黑素组术后表现出疼痛相关面部线索的新生儿较少。两组均未观察到明显不良反应。
与安慰剂相比，口服褪黑素在新生儿静脉穿刺期间显示出自主调节作用并降低了PIPP-R得分，且无不良反应，支持其作为一种镇痛药使用。印度临床试验注册中心：（CTRI）编号-CTRI/2023/07/055046，日期为2023年7月11日。
