Effect of melatonin on incidence of delirium among patients with hip fracture: a multicentre, double-blind randomized controlled trial

Sep 4, 2014CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne

Melatonin's impact on delirium rates in patients with hip fractures: a multicenter, double-blind trial

AI simplified

Circadian Biology on OpenScience ↗PubMed ↗DOI ↗

Abstract

Among 378 patients aged 65 years or older, melatonin treatment showed no significant difference in delirium incidence compared to placebo.

The incidence of delirium was 29.6% in the melatonin group and 25.5% in the placebo group.
The difference in delirium incidence between the two groups was 4.1 percentage points, with a 95% confidence interval of -0.05 to 13.1.
No significant effects of melatonin were observed on mortality or cognitive and functional outcomes at 3-month follow-up.
The study involved a multicentre, double-blind, randomized controlled trial design.
Participants included patients scheduled for acute hip surgery, with a mean age of 84 years.

AI simplified

BACKGROUND: Disturbance of the sleep-wake cycle is a characteristic of delirium. In addition, changes in melatonin rhythm influence the circadian rhythm and are associated with delirium. We compared the effect of melatonin and placebo on the incidence and duration of delirium.

METHODS: We performed this multicentre, double-blind, randomized controlled trial between November 2008 and May 2012 in 1 academic and 2 nonacademic hospitals. Patients aged 65 years or older who were scheduled for acute hip surgery were eligible for inclusion. Patients received melatonin 3 mg or placebo in the evening for 5 consecutive days, starting within 24 hours after admission. The primary outcome was incidence of delirium within 8 days of admission. We also monitored the duration of delirium.

RESULTS: A total of 452 patients were randomly assigned to the 2 study groups. We subsequently excluded 74 patients for whom the primary end point could not be measured or who had delirium before the second day of the study. After these postrandomization exclusions, data for 378 patients were included in the main analysis. The overall mean age was 84 years, 238 (63.0%) of the patients lived at home before admission, and 210 (55.6%) had cognitive impairment. We observed no effect of melatonin on the incidence of delirium: 55/186 (29.6%) in the melatonin group v. 49/192 (25.5%) in the placebo group; difference 4.1 (95% confidence interval -0.05 to 13.1) percentage points. There were no between-group differences in mortality or in cognitive or functional outcomes at 3-month follow-up.

INTERPRETATION: In this older population with hip fracture, treatment with melatonin did not reduce the incidence of delirium.

TRIAL REGISTRATION: Netherlands Trial Registry, NTR1576: MAPLE (Melatonin Against PLacebo in Elderly patients) study; www.trialregister.nl/trialreg/admin/rctview.asp?TC=1576.

Full Text

Full text is available at the source.

View full text ↗

Effect of melatonin on incidence of delirium among patients with hip fracture: a multicentre, double-blind randomized controlled trial

Abstract

Full Text

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the circadian biology brief

Abstract

Full Text

Related papers

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the circadian biology brief