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Related Experiment Video

Updated: Sep 9, 2025

Electrophysiological Measurement of Noxious-evoked Brain Activity in Neonates Using a Flat-tip Probe Coupled to Electroencephalography
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Oral Melatonin for Pain Relief During Venepuncture in Neonates- a Pilot Randomized Control Trial.

Sushree Smita Behura1, Santosh Kumar Panda2, Subhrajyoti Tripathy1

  • 1Department of Paediatrics, Kalinga Institute of Medical Sciences, KIIT DU, Bhubaneswar, Odisha, India.

European Journal of Clinical Pharmacology
|September 3, 2025
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Summary

Oral melatonin effectively reduced pain scores in neonates during venepuncture compared to placebo. This study supports melatonin as a safe and effective analgesic for newborns undergoing painful procedures.

Keywords:
AnalgesicMelatoninNeonatesVenepuncture

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Area of Science:

  • Neonatal care
  • Pharmacology
  • Pain management

Background:

  • Venepuncture is a common and painful procedure in neonates.
  • Effective pain management in neonates is crucial for their well-being and long-term outcomes.
  • Limited pharmacological options are available for neonatal pain relief during procedures.

Purpose of the Study:

  • To compare the analgesic efficacy of oral melatonin versus placebo in neonates undergoing venepuncture.
  • To evaluate the impact of melatonin on pain intensity and autonomic stability during and after the procedure.

Main Methods:

  • A pilot randomized controlled trial involving 60 eligible non-sick neonates (gestational age ≥ 34 weeks).
  • Participants were randomized to receive either oral melatonin (1 mg/kg) or placebo (normal saline).
  • Pain was assessed using the Premature Infant Pain Profile-Revised (PIPP-R) scale, with statistical analysis using the Mann-Whitney U test.

Main Results:

  • Melatonin group showed significantly lower PIPP-R scores during and after venepuncture compared to the placebo group (p < 0.001).
  • Melatonin administration improved autonomic stability, evidenced by lower heart rates and higher oxygen saturation.
  • While procedural facial expressions were similar, fewer neonates in the melatonin group exhibited pain-related facial cues post-procedure.

Conclusions:

  • Oral melatonin demonstrated significant analgesic efficacy in neonates during venepuncture.
  • Melatonin provided autonomic modulation and reduced pain scores without notable adverse effects.
  • The findings support the use of oral melatonin as a safe and effective analgesic in neonatal venepuncture.