Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2026
Comparison of Two Doses of Prophylactic Melatonin on Incidence of Delirium in Intensive Care Unit Patients: A Randomized Controlled Trial.
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Kumar P Ajith, Chawla Kashish, Kohli Santvana, Singh Rajpal
Аннотация
BACKGROUND AND AIMS: Delirium is a frequent and serious complication in critically ill patients, contributing to prolonged mechanical ventilation, extended intensive care unit (ICU) stays, and increased mortality. Disruption of circadian rhythms plays a key role in its pathogenesis. Melatonin, a neurohormone with chronobiotic and antioxidant properties, may help prevent ICU delirium, though the optimal dose remains uncertain.
PATIENTS AND METHODS: This prospective, randomized, interventional study enrolled 120 adult ICU patients, randomized to receive either 3 mg (group A) or 6 mg (group B) oral melatonin nightly for at least 5 days. Baseline parameters were comparable between groups. Delirium incidence was assessed twice daily using the confusion assessment method for the ICU (CAM-ICU). Secondary outcomes included the timing of delirium onset, adverse effects, ICU stay, and mortality.
RESULTS: Delirium occurred in 55.0% of patients in group A and 36.7% in group B (χ² = 4.062, p = 0.044), indicating a significant reduction with 6 mg of melatonin. The mean (SD) day of delirium onset and ICU length of stay were comparable between groups. Daytime somnolence was mild and similar across groups.
CONCLUSIONS: Prophylactic administration of 6 mg of oral melatonin significantly reduced ICU delirium incidence compared with 3 mg, without added adverse effects. Higher-dose melatonin appears safe and more effective for delirium prevention in critically ill adults.
HOW TO CITE THIS ARTICLE: Kumar PA, Chawla K, Kohli S, Singh R. Comparison of Two Doses of Prophylactic Melatonin on Incidence of Delirium in Intensive Care Unit Patients: A Randomized Controlled Trial. Indian J Crit Care Med 2026;30(4):319-323.
PATIENTS AND METHODS: This prospective, randomized, interventional study enrolled 120 adult ICU patients, randomized to receive either 3 mg (group A) or 6 mg (group B) oral melatonin nightly for at least 5 days. Baseline parameters were comparable between groups. Delirium incidence was assessed twice daily using the confusion assessment method for the ICU (CAM-ICU). Secondary outcomes included the timing of delirium onset, adverse effects, ICU stay, and mortality.
RESULTS: Delirium occurred in 55.0% of patients in group A and 36.7% in group B (χ² = 4.062, p = 0.044), indicating a significant reduction with 6 mg of melatonin. The mean (SD) day of delirium onset and ICU length of stay were comparable between groups. Daytime somnolence was mild and similar across groups.
CONCLUSIONS: Prophylactic administration of 6 mg of oral melatonin significantly reduced ICU delirium incidence compared with 3 mg, without added adverse effects. Higher-dose melatonin appears safe and more effective for delirium prevention in critically ill adults.
HOW TO CITE THIS ARTICLE: Kumar PA, Chawla K, Kohli S, Singh R. Comparison of Two Doses of Prophylactic Melatonin on Incidence of Delirium in Intensive Care Unit Patients: A Randomized Controlled Trial. Indian J Crit Care Med 2026;30(4):319-323.