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Delirium is a common complication of illness especially among the elderly with serious sequelae including increased mortality, morbidity and length of stay. This neuropsychiatric emergency has key features including acute onset, fluctuating level of consciousness, poor attention and cognitive deficits with a presentation which may include hallucinations and delusions.
A critical precipitating and maintaining feature of delirium is disrupted sleep. Melatonin is a widely available natural health product with evidence in normalizing circadian rhythms and sleep. There is also preliminary evidence that melatonin can be used to prevent the development of delirium in hospitalized patients. We hypothesize that daily administration of melatonin (1.5mg) in the evening, beginning at first admission to hospital and continuing for 14 days, will lead to decreased rates of delirium compared to placebo-treated comparison subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients given once daily placebo (cellulose) orally in the evening, for 14 days. |
|
| Melatonin | Experimental | Patients given once daily melatonin 1.5mg orally in the evening, for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium (Confusion Assessment Method) | Screening will be performed by a research assistant using the Confusion Assessment Method, and those with positive screening diagnosed by a study physician. | Within 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Confusion (Confusion Assessment Method scores) | Confusion Assessment Method scores. | Within 14 days |
| Mortality | Within 14 days | |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Within 6 months | |
| Time to delirium | Within 14 days | |
| Discharge Functional Status (Physiotherapist or Occupational therapist assessed) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter KY Chan, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver Coastal Health | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Use of restraints |
| Within 14 days |
| Code White (Violence) | Within 14 days |
Physiotherapist or Occupational therapist assessed |
| Within 6 months |
| Discharge Disposition (Unchanged from pre-admission Home Home with supports Rehabilitation Assisted living) | Unchanged from pre-admission Home Home with supports Rehabilitation Assisted living | Within 6 months |
| Sleep (Hours slept according to nursing records) | Hours slept according to nursing records | Within 14 days |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |