Evidence map›Paper›PMID 25183726›Full record

Trial reportCMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne2014

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

Annemarieke de Jonghe, Barbara C van Munster, J Carel Goslings, Peter Kloen, Carolien van Rees, Reinder Wolvius, Romuald van Velde, Marcel Levi, Rob J de Haan, Sophia E de Rooij and 1 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02654314 (Prevention of Delirium in Inpatients Utilizing Melatonin), which is not on this map. Cited by 67 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 10 pooled it
9.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02654314 phase3terminatednot on this mapstarted 2016, after this paper: background citation

Prevention of Delirium in Inpatients Utilizing Melatonin

TypeinterventionalSponsorYale UniversityRan2016 to 2017Enrolled277ConditionsDeliriumArmsMelatonin, Placebo
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 10 syntheses or guidelines pooled it, 168 citations in OpenAlex.

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  10. Interventions for preventing delirium in hospitalised non-ICU patients.The Cochrane database of systematic reviews · 2016
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  16. Effects of Ramelteon on the Prevention of Postoperative Delirium in Older Patients Undergoing Orthopedic Surgery: The RECOVER Randomized Controlled Trial.The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · 2021
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7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Annemarieke de JongheDepartment of Internal Medicine, Geriatrics Section (de Jonghe, van Munster, de Rooij), Department of Surgery, Trauma Unit (Goslings), Department of Orthopedic Surgery (Kloen), Department of Internal Medicine (Levi) and Clinical Research Unit (de Haan), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Geriatrics (van Munster), Gelre Hospitals, Apeldoorn, The Netherlands; Department of Geriatrics (van Rees), Department of Orthopaedic Surgery (Wolvius) and Department of Surgery (van Velde), Tergooi Hospitals, Hilversum, The Netherlands. a.dejonghe@amc.uva.nl.
Barbara C van MunsterDepartment of Internal Medicine, Geriatrics Section (de Jonghe, van Munster, de Rooij), Department of Surgery, Trauma Unit (Goslings), Department of Orthopedic Surgery (Kloen), Department of Internal Medicine (Levi) and Clinical Research Unit (de Haan), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Geriatrics (van Munster), Gelre Hospitals, Apeldoorn, The Netherlands; Department of Geriatrics (van Rees), Department of Orthopaedic Surgery (Wolvius) and Department of Surgery (van Velde), Tergooi Hospitals, Hilversum, The Netherlands.
J Carel GoslingsDepartment of Internal Medicine, Geriatrics Section (de Jonghe, van Munster, de Rooij), Department of Surgery, Trauma Unit (Goslings), Department of Orthopedic Surgery (Kloen), Department of Internal Medicine (Levi) and Clinical Research Unit (de Haan), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Geriatrics (van Munster), Gelre Hospitals, Apeldoorn, The Netherlands; Department of Geriatrics (van Rees), Department of Orthopaedic Surgery (Wolvius) and Department of Surgery (van Velde), Tergooi Hospitals, Hilversum, The Netherlands.
Peter KloenDepartment of Internal Medicine, Geriatrics Section (de Jonghe, van Munster, de Rooij), Department of Surgery, Trauma Unit (Goslings), Department of Orthopedic Surgery (Kloen), Department of Internal Medicine (Levi) and Clinical Research Unit (de Haan), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Geriatrics (van Munster), Gelre Hospitals, Apeldoorn, The Netherlands; Department of Geriatrics (van Rees), Department of Orthopaedic Surgery (Wolvius) and Department of Surgery (van Velde), Tergooi Hospitals, Hilversum, The Netherlands.
Carolien van ReesDepartment of Internal Medicine, Geriatrics Section (de Jonghe, van Munster, de Rooij), Department of Surgery, Trauma Unit (Goslings), Department of Orthopedic Surgery (Kloen), Department of Internal Medicine (Levi) and Clinical Research Unit (de Haan), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Geriatrics (van Munster), Gelre Hospitals, Apeldoorn, The Netherlands; Department of Geriatrics (van Rees), Department of Orthopaedic Surgery (Wolvius) and Department of Surgery (van Velde), Tergooi Hospitals, Hilversum, The Netherlands.
Reinder WolviusDepartment of Internal Medicine, Geriatrics Section (de Jonghe, van Munster, de Rooij), Department of Surgery, Trauma Unit (Goslings), Department of Orthopedic Surgery (Kloen), Department of Internal Medicine (Levi) and Clinical Research Unit (de Haan), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Geriatrics (van Munster), Gelre Hospitals, Apeldoorn, The Netherlands; Department of Geriatrics (van Rees), Department of Orthopaedic Surgery (Wolvius) and Department of Surgery (van Velde), Tergooi Hospitals, Hilversum, The Netherlands.
Romuald van VeldeDepartment of Internal Medicine, Geriatrics Section (de Jonghe, van Munster, de Rooij), Department of Surgery, Trauma Unit (Goslings), Department of Orthopedic Surgery (Kloen), Department of Internal Medicine (Levi) and Clinical Research Unit (de Haan), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Geriatrics (van Munster), Gelre Hospitals, Apeldoorn, The Netherlands; Department of Geriatrics (van Rees), Department of Orthopaedic Surgery (Wolvius) and Department of Surgery (van Velde), Tergooi Hospitals, Hilversum, The Netherlands.
Marcel LeviDepartment of Internal Medicine, Geriatrics Section (de Jonghe, van Munster, de Rooij), Department of Surgery, Trauma Unit (Goslings), Department of Orthopedic Surgery (Kloen), Department of Internal Medicine (Levi) and Clinical Research Unit (de Haan), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Geriatrics (van Munster), Gelre Hospitals, Apeldoorn, The Netherlands; Department of Geriatrics (van Rees), Department of Orthopaedic Surgery (Wolvius) and Department of Surgery (van Velde), Tergooi Hospitals, Hilversum, The Netherlands.
Rob J de HaanDepartment of Internal Medicine, Geriatrics Section (de Jonghe, van Munster, de Rooij), Department of Surgery, Trauma Unit (Goslings), Department of Orthopedic Surgery (Kloen), Department of Internal Medicine (Levi) and Clinical Research Unit (de Haan), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Geriatrics (van Munster), Gelre Hospitals, Apeldoorn, The Netherlands; Department of Geriatrics (van Rees), Department of Orthopaedic Surgery (Wolvius) and Department of Surgery (van Velde), Tergooi Hospitals, Hilversum, The Netherlands.
Sophia E de RooijDepartment of Internal Medicine, Geriatrics Section (de Jonghe, van Munster, de Rooij), Department of Surgery, Trauma Unit (Goslings), Department of Orthopedic Surgery (Kloen), Department of Internal Medicine (Levi) and Clinical Research Unit (de Haan), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Geriatrics (van Munster), Gelre Hospitals, Apeldoorn, The Netherlands; Department of Geriatrics (van Rees), Department of Orthopaedic Surgery (Wolvius) and Department of Surgery (van Velde), Tergooi Hospitals, Hilversum, The Netherlands.
Amsterdam Delirium Study Group
University of Amsterdam · NLAcademic Medical Center · NLGelre Hospitals · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDisturbance 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.

methodsWe 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.

resultsA 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.

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

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

Indexed as

AgedAged, 80 and overArthroplasty, Replacement, HipDeliriumDouble-Blind MethodFemaleFracture Fixation, InternalHip FracturesHumansIncidenceMaleMelatoninMelatonin

Identifiers

PMID25183726
PMCPMC4188685
OpenAlexW1968294120

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.