The effect of Melatonin on the incidence of Delirium in hospitalized patients in the Intensive Care Unit

The effect of Melatonin on the incidence of Delirium in patients hospitalized in the Itensive Care Unit

Randomized clinical trial with control group, parallel groups, double-blind

In this study, 140 patients admitted to the intensive care unit at Shahid Sadoughi Hospital in Yazd and Shahid Beheshti Hospital of Taft from 1/13/2015 to 1/15/2016 were entered into the study on the basis of inclusion and exclusion criteria.Then by random numbers and without the knowledge of the type of intervention divided in 2 groups. In the first group (intervention) 3 mg melatonin and in second group (control) placebo administration will be performed at 9 p.m. for a week or until discharge from ICU. The assessment of delirium will be done on a daily basis by a single educated nurse using Confusion Assessment Method for the ICU (CAM-ICU).

Patients age 30 and over with less than 24 hours duration from ICU admission ,with Glasgow coma scale (GCS) > 8 Patients, without mechanical ventilation with informed consent entered the study and Patients with history of Delirium or mood disorder before ICU admission, Trauma and intracranial hemorrhage, receive medications such as Benzodiazepines, History of epilepsy and seizure attack were excluded.

Intervention: Melatonin (Nature Made), tablet 3 mg, once daily (21:00 AM), orally for 7 consecutive days Control group: Placebo (consists of tricalcium phosphate, magnesium stearate and starch glue which is made in pharmacy faculty of Yazd Shahid Sadoughi University of Medical Sciences ), once daily (at 21:00 AM), orally, for 7 consecutive days.

Delirium

The random number generator was used in our study to assign each patient randomly in intervention or control group.

The random number generator was used in our study to assign each patient randomly in intervention or control group (Randomized clinical trial). The random numbers were given by a study coordinator, who also encodes the drugs with matching random numbers. In addition, we formulated placebo with the same appearance to Melatonin tablet. Therefore, neither the patients nor the researchers evaluating the study outcome knew which patient is receiving Melatonin or placebo, until the study is over and the random code was revealed.