Melatonin Use in Infants Admitted to Intensive Care Units

J Pediatr Pharmacol Ther. 2023;28(7):635-642. doi: 10.5863/1551-6776-28.7.635. Epub 2023 Nov 23.

Abstract

Objectives: Sleep deprivation is a risk factor for delirium development, which is a frequent complication of intensive care unit admission. Melatonin has been used for both delirium prevention and treatment. Melatonin safety, efficacy, and dosing information in neonates and infants is lacking. The purpose of this study was to describe melatonin use in infants regarding indication, dosing, efficacy, and safety.

Methods: This descriptive, retrospective study included infants <12 months of age admitted to an intensive care unit receiving melatonin. Data collection included demographics, melatonin regimen, sedative and analgesic agents, antipsychotics, and delirium-causing medications. The primary objective was to identify the melatonin indication and median dose. The secondary objectives included change in delirium, pain, and sedation scores; change in dosing of analgesic and sedative agents; and adverse event identification. Wilcoxon signed rank tests and linear mixed models were employed with significance defined at p < 0.05.

Results: Fifty-five patients were included, with a median age of 5.5 months (IQR, 3.9-8.2). Most (n = 29; 52.7%) received melatonin for sleep promotion. The median body weight-based dose was 0.31 mg/kg/dose (IQR, 0.20-0.45). There was a statistical reduction in cumulative morphine equivalent dosing 72 hours after melatonin administration versus before, 17.1 versus 21.4 mg/kg (p = 0.049). No adverse events were noted.

Conclusions: Most patients (n = 29; 52.7%) received melatonin for sleep promotion at a median dose was 0.31 mg/kg/dose. Initiation of melatonin was associated with a reduction of opioid exposure; however, there was no reduction in pain/sedation scores.

Keywords: critical care; delirium; melatonin; pediatrics.