This randomized, double-blind, controlled clinical trial is designed to examine the role of melatonin in prophylaxis of delirium in patients admitted to ICU of Alzahra hospital during 2015-2016.
After informed consent, adult patients with less than 24 hours ICU stay, tolerance of tablet dosage form and Glasgow coma scale (GCS) > 8 were included in the study and those with less than 5 days ICU stay duration, hypersensitivity to melatonin or any ingredient of melatonin tablet or placebo, past medical history of epilepsy, seizure attack or history of delirium or mood disorder before ICU admission, severe heart failure, head trauma and those with the Richmond Agitation-Sedation Scale (RASS) -4 or -5 were excluded from the study until sample size of 140 patients. Thereafter, eligible patients will be randomly allocated in intervention or control group. Patients received 3 mg orally melatonin or placebo at 21:00 AM for 5 consecutive days and then they will be followed for more 3 days to evaluate delirium within eight days after start of the study medication. However, if delirium is detected, daily assessment will be continued until presence of delirium or until ICU discharge of patient. Occurrence of delirium will be evaluated daily as primary outcome according to the Confusion Assessment Method-ICU (CAM-ICU). In addition, other related demographic and clinical parameters will be collected.