Scolaris Content Display Scolaris Content Display

Contenido relacionado

Ir a:

Revisiones y protocolos relacionados

Topics

Temas

Study flow diagram
Figuras y tablas -
Figure 1

Study flow diagram

Ir a la figura de la revisiónAbrir en una pestaña nueva

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Ir a la figura de la revisiónAbrir en una pestaña nueva

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.
Figuras y tablas -
Figure 3

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.

Ir a la figura de la revisiónAbrir en una pestaña nueva

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
(studies)

Quality of the evidence
(GRADE)

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)

⊕⊝⊝⊝
very lowa

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)

⊕⊝⊝⊝
very lowb

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)

⊕⊝⊝⊝
very lowc

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)

⊕⊝⊝⊝
very lowd

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)

⊕⊝⊝⊝
very lowe

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)

⊕⊝⊝⊝
very lowf

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
High quality: further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: we are very uncertain about the estimate

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

Figuras y tablas -
Ir a la tabla de la revisión
Table 1. Single study outcome data: melatonin vs no agent

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*

Bourne 2008

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

Bourne 2008

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

Ibrahim 2006

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

Mistraletti 2015

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*

Bourne 2008

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

Bourne 2008

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

Bourne 2008

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*

Mistraletti 2015

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*

Mistraletti 2015

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*

Mistraletti 2015

´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
CI: confidence interval
EEG: electroencephalogram
IQR: interquartile range
n: number of randomized participants
PSG: polysomnography
RCSQ: Richards‐CampbellSleep Questionnaire
SD: standard deviation
SEI: sleep efficiency index
TST: total sleep time
VNR: verbal numeric range

Figuras y tablas -
Table 1. Single study outcome data: melatonin vs no agent
Ir a la tabla de la revisión