Oral Melatonin for Pain Relief During Venepuncture in Neonates- a Pilot Randomized Control Trial.

IF 2.7 3区医学 Q3 PHARMACOLOGY & PHARMACY

European Journal of Clinical Pharmacology Pub Date : 2025-09-03 DOI:10.1007/s00228-025-03914-7

Sushree Smita Behura, Santosh Kumar Panda, Subhrajyoti Tripathy, Ipsa Kujur, Swaranjika Sahoo, Deepti Damayanty Pradhan

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Abstract

Purpose: This study aims to compare the analgesic efficacy of oral melatonin with placebo in neonates during venepuncture.

Methods: 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.

Results: 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.

Conclusion: 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.

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口服褪黑素缓解新生儿静脉穿刺疼痛-一项随机对照试验。

目的：比较口服褪黑素与安慰剂在新生儿静脉穿刺中的镇痛效果。方法：这项开放水平，试点随机对照试验在三级护理新生儿病房进行。60例符合条件的无病新生儿（胎龄≥34周）计划静脉穿刺，随机分为褪黑素组（MG, n = 30）和安慰剂组（PG, n = 30）。MG组给予口服褪黑素（1mg /kg）， PG组给予生理盐水2ml。在手术期间和手术后1分钟和2分钟，通过修订的早产儿疼痛概况（PIPP-R）测量疼痛强度。两组评分比较采用Mann-Whitney U检验，效应量采用秩-双列相关系数计算。结果：两组患者人口学特征具有可比性。MG和PG在手术过程中PIPP-R评分中位数（Q1-Q3）分别为10（9-10）和13 (12-14),r = 0.8， p结论：与安慰剂相比，口服褪黑素在静脉穿刺期间显示自主调节和降低新生儿PIPP-R评分，无不良反应，支持其作为镇痛药的使用。印度临床试验登记处：（CTRI）编号- CTRI/2023/07/055046，日期为2023年7月11日。

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来源期刊

European Journal of Clinical Pharmacology 医学-药学

CiteScore

5.40

自引率

3.40%

发文量

170

审稿时长

3-8 weeks

期刊介绍： The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed. Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor. Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves -a compound that is interesting and new in some basic or fundamental way, or -methods that are original in some basic sense, or -a highly unexpected outcome, or -conclusions that are scientifically novel in some basic or fundamental sense.