156 / 180
312
ciones. El caso de laringospasmo ocurrió en un paciente
que recibió Ketamina, y la aspiración y las intubaciones
ocurrieron en pacientes que recibieron propofol. Cuando
el propofol y la Ketamina se combinan, las incidencias de
agitación, apnea, hipoxia, bradicardia, hipersensibilidad y
vómitos fueron más bajas comparadas con cada medica-
ción por separado.
Conclusiones:
Los eventos adversos graves durante sedación
para procedimientos como el laringoespasmo, aspiración
e intubación, son extremadamente raros. Se proporcionan
estimaciones cuantitativas de riesgo para facilitar la toma de
decisiones compartida, la comunicación de los riesgos y el
consentimiento informado.
for hypoxia. Chest x-ray revealed aspiration pneumoni-
tis. She was admitted to the hospital and extubated 12
Table 2
Meta-analysis of the Events by Medication Used for Sedation
Adverse Events
Etomidate Ketamine Ketamine/Propofol
Midazolam Midazolam/Opiate Propofol
Agitation
Events
0/218
97/686
39/912
0/746
0/192
8/3,877
Estimate per 1,000
0
164.1
48.1
0
0
0.7
95% CI
0
–
20.8
94.8
–
233.5
12.9
–
83.3
0
–
6.2
0
–
23.6
0
–
1.6
I
2
(%)
0
90
64
0
0
0
Apnea
Events
4/381
5/834
15/348
10/277
34/1,424
Estimate per 1,000
10.4
6.1
51.4
25.9
13.2
95% CI
0.3
–
20.5
0.8
–
11.4
5.5
–
97.3
3.8
–
47.9
6.7
–
19.7
I
2
(%)
0
0
66
30
15
Aspiration
Events
0/145
0/24
0/186
0/49
1/1,818
Estimate per 1,000
0
0
0
0
1.0
95% CI
0
–
31
0
–
163.1
0
–
24.4
0
–
86.8
0
–
2.4
I
2
(%)
0
NA
NA
0
0
Bradycardia
Events
9/194
0/114
0/55
0/186
1/31
1/257
Estimate per 1,000
40.2
0
0
0
32.3
7
95% CI
9.7
–
70.7
0
–
39.2
0
–
78
0
–
24.4
0
–
94.5
0
–
17.2
I
2
(%)
17
0
0
NA
NA
0
Hypotension
Events
4/334
4/232
4/834
7/824
4/323
77/3,254
Estimate per 1,000
10.8
11.8
6.1
6.1
15.4
19.1
95% CI
0
–
21.8
0
–
25.6
0.8
–
11.3
0.8
–
11.3
2.1
–
28.8
12
–
26.3
I
2
(%)
0
0
0
0
0
50
Hypoxia
Events
24/538
33/660
5/864
32/826
18/392
236/3,688
Estimate per 1,000
35.2
28.3
3.2
51.2
27.5
57.7
95% CI
14.5
–
56
9.1
–
47.6
0
–
7
17.5
–
84.9
2
–
53.1
43.6
–
71.8
I
2
(%)
41
65
0
90
68
85
Intubation
Events
0/412
0/161
0/55
0/283
0/67
2/2,510
Estimate per 1,000
0
0
0
0
0
1.2
95% CI
0
–
11.1
0
–
28
0
–
78
0
–
16.1
0
–
64.9
0
–
2.6
I
2
(%)
0
0
0
0
0
0
Laryngospasm
Events
1/563
0/24
0/186
0/110
Estimate per 1,000
4.9
0
0
0
95% CI
0
–
10.7
0
–
163.1
0
–
24.4
0
–
40.5
I
2
(%)
0
NA
NA
NA
Vomiting
Events
13/412
71/439
2/889
4/275
2/342
8/814
Estimate per 1,000
21.7
170
1.7
12.1
11.3
7.1
95% CI
6.6
–
36.9
97.3
–
242.8
0
–
4.3
0
–
25
0.2
–
22.5
1.4
–
12.7
I
2
(%)
14
89
0
0
0
0
The I
2
is not calculated when there is only one study in the meta-analysis.
Table 3
Sensitivity Analysis, Events Rates in RCTs
ACADEMIC EMERGENCY MEDICINE • February 2016, Vol. 23, No. 2 •
www.aemj.org123
S vere adverse events requiring emergent medical
intervention wer rare, with one case of aspiratio in
2,370 sedations (1.2 per 1,000), one case of laryn-
gospasm in 883 sedations (4.2 per 1,000), a d two intu-
bations in 3,636 sedations (1.6 per 1,000). The incidence
of adverse events per medication used is displayed in
Table 2.
Results by Outcome
Agitation.
A total of 33 studies including 6,631 seda-
tions on 6,558 patients reported the outcome of agita-
tion. The incidence of agitation was 9.8 per 1,000 (95%
CI
=
6.1 to 13.5). There were 25 of 997 patients who
received medication to treat agitation, with an incidence
of 27.1 per 1,000 (95% CI
=
9.5 to 44.7). Ketamine and
ketamine/propofol had the highest rate of agitation.
Among the studies that used ketamine, the incidence of
agitation was 164.1 per 1,000 sedations (95% CI
=
94.8
to 233.5), and among those receiving ketamine/propofol,
48.1 per 1,000 sedations (95% CI
=
12.9 to 83.3; see Fig-
ure 2).
8,9,13,21,27,30,36
–
64
Apnea.
Apnea was reported in 22 studies, comprising
68 events in 3,264 sedations on 3,264 patients. The inci-
dence was 12.4 per 1,000 sedations (95% CI
=
7.9 to
16.9). The use of midazolam (51.4 per 1,000 sedati ns,
95% CI
=
5.5 to 97.3) and the combination of midazo-
lam/opiate (25.9 per 1,000 sedations, 95% CI
=
3.8 to
47.9) had the highest incidence of apnea (see Data Sup-
plement S7a, available as supporting information in the
online version of this paper, for forest plots of the inci-
dence of apnea by medication).
Aspiration.
A total of 10 studies including 2,370 seda-
tions on 2,370 patients reported the outcome of aspira-
tion. Aspiration occurred in one case (1.2 per 1,000
sedations, 95% CI
=
0 to 2.6) receiving propofol and
fentanyl. The case of aspiration was a 65-year-old
female who underwent sedation with fentanyl and
propofol for the reduction of an ankle fracture.
36
The
fi
rst attempt to reduce the fracture was unsuccessful,
and the patient was sedated for a second time hour
later. She vomited and aspirated, requiring intubation
Figure 1.
Flow diagram of study selection process.
Table 1
Incidence of Adverse Events per 1,000 Procedural Sedations (Meta-analysis)
Adverse Event
Events per Sedations
Estimate per 1,000
95% CI
I
2
(%)
Agitation
137/6,631
9.8
6.1
–
13.5
73.6
Apnea
68/3,264
12.4
7.9
–
16.9
16.05
Aspiration
1/2370
1.2
0.0
–
2.6
0.0
Bradycardia
11/837
6.5
1.1
–
11.8
0.0
Hypotension
122/5,801
15.2
10.7
–
19.7
42.9
Hypoxia
373/7,116
40.2
32.5
–
47.9
81.8
Intubation
2/3,636
1.6
0.3
–
2.9
0.0
Laryngospasm
1/883
4.2
0.0
–
8.5
0.0
Vomiting
100/3,319
16.4
9.7
–
23
65.3
[REV. MED. CLIN. CONDES - 2017; 28(2) 311-313]