Delirium. Delirium, unspecified
Conditions
Interventions
Intervention 1: Intervention: Melatonin (Nature Made), tablet 3 mg, once daily (21:00 AM), orally for 5 consecutive days. Intervention 2: Control group: Placebo (consists of tricalcium phosphate, magn
Prevention
Placebo
Intervention: Melatonin (Nature Made), tablet 3 mg, once daily (21:00 AM), orally for 5 consecutive days
Control group: Placebo (consists of tricalcium phosphate, magnesium stearate and starch glue which is made in pharmacy faculty of Isfahan University of Medical Sciences), once daily (at 21:00 AM), ora
Sponsors
Vice chancellor for research, Isfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Adult patients (> 18 years old) with less than 24 hours duration from ICU admission 2. Normal gastrointestinal function (can tolerate tablet dosage form) Exclusion Criteria: 1. GCS= 8 2. Duration of ICU stay less than 5 days 3. Hypersensitivity to melatonin or any ingredient of melatonin tablet or placebo 4. Past medical history of epilepsy or any seizure attack. 5. Severe heart failure (New York Heart Association classification III/IV) 6. Head trauma 7. RASS (The Richmond Agitation-Sedation Scale) = -4 or -5 8. Past medical history of delirium or mood disorder before ICU admission
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of delirium. Timepoint: Daily (from initial of study for 8 days). Method of measurement: CAM-ICU. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of delirium. Timepoint: Daily (from initial of study for 8 days). Method of measurement: Daily evaluation of delirium by CAM-ICU. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShadi Farsaei
Isfahan University of Medical Sciences
Outcome results
None listed