Melatonina para la inducción del sueño en adultos en la unidad de cuidados intensivos
Información
- DOI:
- https://doi.org/10.1002/14651858.CD012455.pub2Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 10 mayo 2018see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Atención crítica y de emergencia
- Copyright:
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- Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
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Autores
Contributions of authors
Sharon R Lewis (SRL), Michael W Pritchard (MWP), Oliver Schofield‐Robinson (OSR), Phil Alderson (PA), Andrew F Smith (AS).
Conceiving of the review: SRL.
Co‐ordinating the review: SRL.
Undertaking manual searches: SRL, OSR, MWP.
Screening search results: SRL, OSR, MWP.
Organizing retrieval of papers: SRL, OSR.
Screening retrieved papers against inclusion criteria: SRL, OSR, MWP.
Appraising the quality of papers: SRL, OSR, MWP.
Abstracting data from papers: SRL, OSR, MWP.
Writing to authors of papers for additional information: SRL.
Providing additional data about papers: SRL.
Managing data for the review: SRL.
Entering data into Review Manager (Review Manager 2014): SRL.
Interpreting data: SRL, OSR, MWP.
Making statistical inferences: SRL.
Writing the review: SRL, MWP.
Securing funding for the review: AS.
Serving as guarantor for the review (one review author): AS.
Taking responsibility for reading and checking the review before submission: SRL, MWP, AS, PA.
Sources of support
Internal sources
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No sources of support supplied
External sources
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NIHR Cochrane Programme Grant: 13/89/16, UK.
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This project was supported by the National Institute for Health Research, via Cochrane Programme Grant funding. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.
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Declarations of interest
Sharon R Lewis: See Sources of support.
Michael W Pritchard: See Sources of support.
Oliver J Schofield‐Robinson: See Sources of support.
Phil Alderson: See Sources of support.
Andrew F Smith: See Sources of support.
Acknowledgements
We would like to thank the following for help and editorial advice during the preparation of this systematic review: Nicola Petrucci (Content Editor); Marialena Trivella (Statistical Editor); Harald Herkner (Co‐ordinating Editor); Brian Gehlbach, Russel J Roberts, Gerald Weinhouse, Andrew MacDuff (Peer Reviewers); and Edward Grandi (Consumer Referee).
We would like to thank the following for help and editorial advice provided during preparation of the protocol: Nicola Petrucci (Content Editor); Asieh Golozar (Statistical Editor); and Gerald Weinhouse and Brian Gehlbach (Peer Reviewers) (Lewis 2016b).
Version history
| Published | Title | Stage | Authors | Version |
| 2018 May 10 | Melatonin for the promotion of sleep in adults in the intensive care unit | Review | Sharon R Lewis, Michael W Pritchard, Oliver J Schofield‐Robinson, Phil Alderson, Andrew F Smith | |
| 2016 Nov 28 | Melatonin for the promotion of sleep in the intensive care unit | Protocol | Sharon R Lewis, Phil Alderson, Andrew F Smith | |
Differences between protocol and review
We made the following changes to the published protocol (Lewis 2016b).
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Summary of findings: we did not use two review authors to independently create a 'Summary of findings' table. One review author carried out this task, with discussion and agreement with a second author.
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
- *Intensive Care Units;
- Central Nervous System Depressants [*therapeutic use];
- Critical Care;
- Lighting [adverse effects];
- Melatonin [*therapeutic use];
- Noise, Occupational [adverse effects];
- Randomized Controlled Trials as Topic;
- Respiration, Artificial;
- Sleep [*drug effects];
- Sleep Initiation and Maintenance Disorders [*drug therapy, etiology];
Medical Subject Headings Check Words
Adult; Humans;
PICO
Study flow diagram
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study. Blank spaces in figure indicate that outcomes were not reported by study authors, and therefore risk of bias was not completed for these domains.
| Melatonin compared with no agent for the promotion of sleep in adult patients in the ICU | ||||
| Patient or population: adult patients in the ICU Settings: ICUs, in Australia, Italy, UK, and US Intervention: melatonin Comparison: no agent | ||||
| Outcomes | Impacts | No of participants | Quality of the evidence | Comments |
| Quantity and quality of sleep as measured through reports of participants or of family members or by personnel assessments Data collected at end of follow‐up | In 1 study, participants completed the RCSQ and study authors reported no difference in SEI scores between groups. This was consistent with nurse assessment for which study authors also reported no difference in SEI scores between groups 2 studies reported no difference in duration of sleep observed by nurses | 139 (3 studies) | ⊕⊝⊝⊝ | We did not conduct meta‐analysis because studies used different methods to report data |
| Quantity and quality of sleep as measured by PSG, actigraphy, BIS, or EEG Data collected at end of follow‐up | In 1 study, investigators used BIS and actigraphy to record sleep. Study authors reported no difference in SEI scores with both tools. Study authors also reported longer sleep in participants given melatonin which was not statistically significantly different, and also reported evidence of improved sleep in participants given melatonin from analysis of AUC using BIS data 1 study used PSG, with a large loss of participant data at follow‐up, which prevented analysis of sleep data | 37 (2 studies) | ⊕⊝⊝⊝ | We did not conduct meta‐analysis because studies differed in types of measurement tools |
| Anxiety or depression, or both Data collected at end of follow‐up | 1 study (using VNR ≥ 3) reported no evidence of a difference in anxiety scores between groups | 82 (1 study) | ⊕⊝⊝⊝ | We identified only one study and could not conduct meta‐analysis |
| Mortality Study authors did not report final timepoint for data collection. | 1 study reported one‐third of participants had died; number of deaths per group was not reported 1 study reported no evidence of a difference between groups in hospital mortality | 94 (2 studies) | ⊕⊝⊝⊝ | We did not conduct meta‐analysis because studies different in methods of reporting data |
| Length of stay in the ICU | One study reported no evidence of a difference in length of ICU stay between groups | 82 (1 study) | ⊕⊝⊝⊝ | We identified only 1 study and could not conduct meta‐analysis |
| Adverse events (such as nausea, dizziness and headache) Data collected at end of follow‐up | 1 study reported headache in one participant who was given melatonin 1 study reported a cutaneous rash in one participant in the control group, and 2 participants (1 participant in both groups) with excessive sleepiness | 107 (2 studies) | ⊕⊝⊝⊝ | We could not conduct meta‐analysis because studies different in reported types of adverse events |
| Acronyms and abbreviations AUC: area under the curve; BIS: bispectral index; EEG: electroencephalogram; ICU: intensive care unit; PSG: polysomnography; RCSQ: Richards‐Campbell Sleep Questionnaire; SEI: sleep efficiency index; VNR: verbal numeric range | ||||
| GRADE Working Group Grades of Evidence | ||||
| aWe downgraded by 2 levels for imprecision; there were few studies with few participants, and outcome measures included both personnel and participant reports. We downgraded by 1 level for study limitations; we noted differences in baseline characteristics in two studies which may have influenced results. We downgraded by 1 level for inconsistency; we noted differences in doses of melatonin given in each study. We downgraded by 1 level for indirectness; we could not be certain that ICU sedation protocols in one study were generalizable to most ICUs bWe downgraded by 2 levels for imprecision; there were few studies very few participants, and outcome measures used different assessment tools which may not effectively measure sleep in the ICU patient. We downgraded by 1 level for study limitations; we noted differences in baselines characteristics in one study which may have influenced results. We downgraded 1 level for inconsistency; we noted differences in doses of melatonin given in each study. We downgraded by 1 level for study limitations; we noted high risk of performance bias and high attrition which prevented adequate outcome reporting cWe downgraded by 2 levels for imprecision; data was from one study with few participants, and we could not be certain whether this outcome was measured with an appropriate tool for patients in the ICU. We downgraded by 1 level for study limitations; pre‐treatment use of opiates differed between study groups. We downgraded by 1 level for indirectness; we could not be certain that ICU sedation protocols in 1 study were generalizable to most ICUs dWe downgraded by 2 levels for imprecision; there were few studies with few participants. We downgraded by 1 level for study limitations; we noted a high risk of performance bias and attrition bias in one study and we noted differences between groups in pre‐treatment use of opiates. We downgraded 1 level for inconsistency; doses of melatonin varied between studies. We downgraded by 1 level for indirectness; we could not be certain that ICU sedation protocols in 1 study were generalizable to most ICUs eWe downgraded by 2 levels for imprecision; data was from one study. We downgraded by 1 level for study limitations; pre‐treatment use of opiates differed between study groups. We downgraded by 1 level for indirectness; we could not be certain that ICU sedation protocols in 1 study were generalizable to most ICUs fWe downgraded by 2 levels for imprecision; there were few studies with few participants. We downgraded by 1 level for study limitations; we noted differences in baseline characteristics in two studies which may have influenced results. We downgraded by 1 level for indirectness; we could not be certain that ICU sedation protocols in 1 study were generalizable to most ICUs | ||||
| Outcome: quantity and quality of sleep as measured through reports of participants or family members or by personnel assessments | |||||
| Study | Measurement (tool) | Data* Intervention | Data* Control | Mean difference (95% CI)* | P value* |
| SEI, patient assessment (RCSQ) | mean (95% CI): 0.41 (0.24 to 0.59); n: 12 | mean (95% CI): 0.50 (0.43 to 0.58); n: 12 | −0.09 (−0.28 to 0.09) | 0.32 | |
| SEI, nurse assessment (observations) | mean (95% CI): 0.45 (0.26 to 0.64); n: 12 | mean (95% CI): 0.51 (0.35 to 0.68); n: 12 | −0.06 (CI −0.29 to 0.17) | 0.58 | |
| Duration of sleep, nurse assessment (observations) | median (range): 240 minutes (75 to 331.3); n: 14 | median (range): 243.4 minutes (0 to 344.1); n: 18 | not reported | 0.98 | |
| Duration of sleep, nurse assessment (observations) | 9 p.m. to midnight, mean (SD): 1.5 (± 1.6) hours; n: 41 midnight to 7 a.m., mean (SD): 4.5 (± 1.9) hours; n: 41 | 9 p.m. to midnight, mean (SD): 1.4 (± 1.3) hours; n: 41 midnight to 7 a.m., mean (SD): 4.3 (± 1.8) hours; n: 41 | not reported | 0.92 0.83 | |
| Outcome: quantity and quality of sleep as measured by PSG, actigraphy, BIS, or EEG | |||||
| Study | Measurement (tool) | Data* Intervention | Data* Control | Mean difference (95% CI)* | P value* |
| SEI (BIS) | Mean (95% CI): 0.39 (0.27 to 0.51); n: 12 | Mean (95% CI): 0.26 (0.17 to 0.36); n: 12 | 0.12 (CI −0.02 to 0.27) | 0.09 | |
| SEI (actigraphy) | Mean (95% CI): 0.73 (0.53 to 0.93); n: 12 | Mean (95% CI): 0.75 (0.67 to 0.83); n: 12 | −0.02 (CI −0.24 to 0.20) | 0.84 | |
| Quantity of nocturnal sleep (BIS) | Mean: 3.5 hours; n: 12 | Mean: 2.5 hours; n: 12 | Not reported | ‐ | |
| Outcome: anxiety or depression, or both | |||||
| Study | Measurement (tool) | Data* Intervention | Data* Control | Mean difference (95% CI)* | P value* |
| Anxiety (using VNR) | Participants with score ≥ 3: 12; n: 41 | Participants with score ≥ 3: 14; n: 41 | Not reported | 0.10 | |
| Outcome: mortality at 30 days | |||||
| Study | Measurement | Data* Intervention | Data* Control | Mean difference (95% CI)* | P value* |
| Mortality in hospital | 14; n: 41 | 15; n: 41 | Not reported | 0.82 | |
| Outcome: length of stay in the ICU | |||||
| Study | Measurement | Data* Intervention | Data* Control | Mean difference (95% CI)* | P value* |
| ´Number of days | Median (IQR): 14 (8 to 20); n: 41 | median (IQR): 12 (9 to 29); n: 41 | Not reported | 0.75 | |
| * as reported by study authors BIS: bispectral index | |||||
