Moderate dose melatonin for the abatement and treatment of delirium in elderly general medical inpatients: study protocol of a placebo controlled, randomised, double blind trial.
BMC Geriatr
; 16: 54, 2016 Feb 29.
Article
em En
| MEDLINE
| ID: mdl-26928392
ABSTRACT
BACKGROUND:
Delirium is a frequent, costly and morbid problem. No agent has been shown to modify the natural history of the condition, and current treatments have significant side effects. Prophylactic melatonin in low doses has been shown to prevent delirium developing. This trial then aims to determine the feasibility of a trial to assess if melatonin at a moderate dose effectively treats the symptoms of delirium and modifies the natural history, including abating symptoms after treatment cessation. METHODS/DESIGN:
Elderly (≥70 years of age) patients admitted to the Royal Melbourne Hospital with delirium, and not requiring surgery, will be identified from the current practice of the investigators and through referral by other general medical unit staff. To facilitate this, other staff will be briefed on the project by investigators. Patients will be recruited with suitable informed and documented consent (person responsible) by the study investigators. They will receive orally either 5 mg melatonin (18 patients) or placebo (18 patients) nightly for 5 nights (or until discharged). During treatment, participants will be assessed by study staff using a validated scale of delirium severity (the Memorial Delirium Assessment Scale), and a validated measure of delirium state (Confusion Assessment Method) to determine if melatonin decreases the severity or the duration of delirium. Assessment will continue for a further two days after treatment has ceased, to determine if the treatment causes persisting abatement of symptoms, and to assess for adverse events.DISCUSSION:
The on-going study described herein will contribute to our knowledge of available treatment options for elderly inpatients with delirium, where current pharmacological interventions show weak or no effect on hastening the resolution of delirium. As melatonin is safe, cheap, and potentially effective, it would be easily implementable in routine practice and could lead to significant outcome benefits for delirious inpatients. TRIAL REGISTRATION The trial is registered with the Australia New Zealand Clinical Trials Registry (trial ID ACTRN12614000101684 ) (registered 28/01/2014).
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Delírio
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Pacientes Internados
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Melatonina
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
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Guideline
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Observational_studies
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Prognostic_studies
Limite:
Aged
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Aged80
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Female
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Humans
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Male
Idioma:
En
Revista:
BMC Geriatr
Assunto da revista:
GERIATRIA
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
Austrália