RT Journal Article
SR Electronic
T1 Effect of melatonin on incidence of delirium among patients with hip fracture: a multicentre, double-blind randomized controlled trial
JF Canadian Medical Association Journal
JO CMAJ
FD Canadian Medical Association
SP cmaj.140495
DO 10.1503/cmaj.140495
A1 Annemarieke de Jonghe
A1 Barbara C. van Munster
A1 J. Carel Goslings
A1 Peter Kloen
A1 Carolien van Rees
A1 Reinder Wolvius
A1 Romuald van Velde
A1 Marcel Levi
A1 Rob J. de Haan
A1 Sophia E. de Rooij
A1 Sophia E. de Rooij
A1 on behalf of the Amsterdam Delirium Study Group
YR 2014
UL http://www.cmaj.ca/content/early/2014/09/02/cmaj.140495.abstract
AB 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