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Pharmacokinetics of Intravenous Melatonin in Preschool-Aged Pediatric Surgical Patients

Anne Louise de Barros Garioud1,2, Arash de Barros Afshari1,2, Lau Romlund Halgreen3

  • 1Department of Anesthesiology, Juliane Marie Center, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.

Paediatric Anaesthesia
|June 22, 2026
PubMed

Insights

Intravenous melatonin in pediatric surgical patients showed pharmacokinetic parameters similar to adults. This study supports its use in children for perioperative care, with no significant adverse events observed.

Area of Science:

  • Pediatric Anesthesiology
  • Pharmacokinetics
  • Sleep Medicine

Background:

  • Melatonin offers potential perioperative benefits in children, including managing anxiety, pain, and delirium.
  • Limited pharmacokinetic data exists for young children, hindering optimal dosing.
  • This study investigated intravenous melatonin pharmacokinetics in pediatric surgical patients.

Purpose of the Study:

  • To determine the pharmacokinetic parameters of an intravenous melatonin bolus in pediatric surgical patients aged 1-6 years.
  • To compare these parameters with those established in adult populations.
  • To assess the safety and preliminary clinical outcomes associated with intraoperative melatonin administration.

Main Methods:

  • Twenty pediatric patients (1-6 years) received an intravenous melatonin dose of 0.15 mg·kg⁻¹ before the end of surgery.
  • Blood samples were collected at multiple time points (baseline, 0, 15, 30, 60, 90 min) post-injection.
  • Plasma melatonin concentrations were analyzed using High-Performance Liquid Chromatography with Fluorescence Detection (HPLC-FLD), and pharmacokinetic parameters were calculated via non-compartmental analysis.

Main Results:

  • Pharmacokinetic analysis included 98 samples, revealing a Cmax of 416,298 pg·mL⁻¹ and an elimination half-life (t½) of 35.2 minutes.
  • Key parameters included clearance (CL) of 0.0183 L·min⁻¹·kg⁻¹ and volume of distribution (Vd) of 0.92 L·kg⁻¹.
  • No emergence delirium was observed; mean FLACC pain scores were low (1.3), with average awakening and discharge readiness times of 1 and 2 hours, respectively. Adverse events were consistent with routine postoperative symptoms.

Conclusions:

  • Intravenous melatonin at 0.15 mg·kg⁻¹ in 1-6-year-olds demonstrated pharmacokinetic characteristics comparable to adults.
  • Postoperative events were within expected ranges, suggesting a favorable safety profile.
  • These findings support the use of this melatonin dosage for future trials investigating its perioperative efficacy in children.
Abstract

Keywords:
anxietyemergence deliriummelatoninpharmacokineticspostoperative pain

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