A Dose Ranging Study of Dexamethasone for Preventing

Patient-Controlled Analgesia-Related Nausea and Vomiting:

A Comparison of Droperidol with Saline
Yi Lee, MD, Hsien-Yung Lai, MD, Pei-Chin Lin, MD, Youh-Sun Lin,
Shen-Jer Huang, MD, and Ming-Hwang Shyr, MD, PhD

MD,

From the Department of Anesthesiology, Buddhist Tzu-Chi Medical Center, Tzu-Chi University School of Medicine,
Hualien, Taiwan

We designed this study to determine the minimum

dose of dexamethasone for preventing nausea and
vomiting associated with the use of morphine by
patient-controlled analgesia (PCA). Two hundred forty
female patients were randomly assigned to receive
dexamethasone 2, 4, 8, or 12 mg IV immediately before
induction of anesthesia. Droperidol (0.1 mg/mL with
morphine 1 mg/mL in PCA pump) and saline were
used as controls. The complete response (no postoperative nausea and vomiting and no need for rescue antiemetic for a 24-h postoperative period) rates for dexamethasone 8 mg (72.2%) and 12 mg (78.9%) were

significantly more than for saline (42.9%) (P 0.05).

Patients who received dexamethasone 12 or 8 mg also
reported higher patient satisfaction than those who received saline (P 0.05). These results were as effective
as adding droperidol 0.1 mg/mL to the morphine PCA
without causing drowsiness, restlessness, or arrhythmias. Smaller doses of dexamethasone (4 or 2 mg) were
not effective for this propose. The results suggest that
dexamethasone 8 mg IV is the minimum effective dose
for the reduction of PCA morphine-related nausea and
vomiting.
(Anesth Analg 2004;98:1066 71)

atient-controlled analgesia (PCA) has been extensively used for the treatment of postoperative
pain. However, PCA-based opioid administration is associated with a frequent incidence of postoperative nausea and vomiting (PONV). A systemic review suggested that the incidence of PONV with PCAmorphine is approximately 50% (1).
Droperidol is antiemetic even when small doses
(1 mg) are used (2). However, the effect is shortlived, suggesting that a repeated bolus of small doses
of droperidol should be used to achieve the best antiemetic effect (2,3). Trame`r and Walder (1) suggested
that concomitant use of a small dose of droperidol
with morphine is an effective means to prevent nausea
and vomiting. Lamond et al. (4) demonstrated that
droperidol 0.10 mg/mL with morphine 1 mg/mL in

the PCA container is the optimal dose for preventing

PONV.
Dexamethasone has been effective in decreasing
PONV after general anesthesia (5,6). Recently, we (7)
have found that dexamethasone 8 mg administered IV
immediately before induction of anesthesia significantly decreases the incidence of PCA-morphine related nausea and vomiting. Despite this antiemetic
effect, however, the optimal dose of dexamethasone
for this purpose has not been determined.
In this randomized, double-blind, placebo-controlled
study, we evaluated the antiemetic effects of four different doses of dexamethasone (2, 4, 8, and 12 mg) on
PCA morphine-related nausea and vomiting. Droperidol (0.10 mg/mL) and saline were used as controls.

Accepted for publication October 23, 2003.

Address correspondence to Ming-Hwang Shyr, MD, PhD, Department of Anesthesiology, Buddhist Tzu-chi Medical Center,
Tzu-chi University School of Medicine, No. 707, Sec 3, ChungYang Road, Hualien, 970, Taiwan. Address reprint requests to Yi
Lee, MD, Department of Anesthesiology, Tzu-Chi Medical Center, Tzu-Chi University School of Medicine, no. 707, Sec 3,
Chung-Yang Road, Hualien, Taiwan, ROC. Address e-mail to
dr.stone@msa.hinet.net or drleeyi@sinamail.com.

Methods

DOI: 10.1213/01.ANE.0000105875.05357.A0

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Anesth Analg 2004;98:106671

The study was conducted with the appropriate institutional approval, and written informed consent was
obtained from all patients. A total of 240 ASA physical status III female patients scheduled for major
orthopedic (total hip or knee replacement or corrective spinal procedures), general (laparotomy), or gynecological surgery (abdominal total hysterectomy,
2004 by the International Anesthesia Research Society
0003-2999/04

ANESTH ANALG
2004;98:1066 71

myomectomy) under general anesthesia were enrolled

in this randomized, double-blind, placebo-controlled
study. Patients who had received any antiemetic medications in the 24 h before surgery or complained of
preoperative nausea or vomiting were excluded. Individuals with a history of immunosuppression, significant gastric reflux, peptic ulcer disease, diabetes mellitus,
recent tuberculosis, Cushings syndrome, liver/renal
diseases, or for whom intubation during induction of
anesthesia was difficult were also deemed ineligible.
Before the surgery, patients were taught to use the PCA
pump (Pain Management Provider; Abbott Laboratories,
North Chicago, IL) and were informed that they could
request rescue antiemetics if necessary.
Patients were randomly assigned to 1 of 6 groups (n
40 each) using a computer-generated random number table. The study medication (3 mL), containing
0.9% saline for the droperidol and saline-control
groups and 2 mg, 4 mg, 8 mg, and 12 mg of dexamethasone for the four dexamethasone groups, was administered IV immediately before induction of anesthesia.
Postoperatively, the dexamethasone and salinecontrol groups received PCA morphine 1 mg/mL. The
droperidol-control group received the same concentration of morphine combined with droperidol
0.1 mg/mL. All patients were blinded to the nature of
the drug administered. The study medication preparations were performed by a specially trained nurseanesthetist who was not involved in any subsequent
assessments.
The anesthesia was standardized for all patients.
Glycopyrrolate 0.2 mg, fentanyl 2 g/kg, and thiopental 5 mg/kg were used for the induction of anesthesia.
Tracheal intubation was facilitated by administration
of rocuronium 0.8 mg/kg. Anesthesia was maintained
by sevoflurane 2%5% (inspired concentrations) and
50% nitrous oxide in oxygen. Ventilation was mechanically controlled and adjusted to maintain end-tidal
CO2 values between 4 and 5.3 kPa throughout the
surgery. Additional rocuronium was administered as
required. All patients received ketorolac 30 mg IV
approximately 30 min before the end of surgery. For
reversal of residual muscle relaxation, the combination of glycopyrrolate 0.6 mg and neostigmine 3 mg
were administered IV and the trachea was extubated.
No opioids were given during the operation.
Postoperatively, all patients received an initial dose
of morphine (0.05 mg/kg) immediately before initiation of PCA. The PCA device was programmed to
deliver a 1-mL bolus of morphine solution (with or
without addition of droperidol), with a 5-min lockout
interval. No background infusion was used. Rescue
medication (metoclopramide 10 mg) was given IV if
the patient experienced more than 15 min of nausea,
had experienced an emetic episode, or if the patient
requested antiemetic medication. The treatment was
repeated if necessary.

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The incidence of PONV and the amount of morphine used were recorded by specially trained nurse
anesthetists who were blinded as to the treatment
groups at 2, 12, and 24 h after operation. Nausea was
measured using an 11-point numerical rating scale
with 0 no nausea and 10 nausea as bad as it can
be. A score of 8 was considered severe, 4 to 7
moderate, and 3 mild nausea. In this study, retching and vomiting were grouped together under the
common term emetic episodes (8). An emetic episode was defined as vomiting/retching events occurring in rapid sequence within a 1-min period. If the
interval between 2 bouts of emesis exceeded 1 min,
they were considered separate episodes. If there were
more than 4 episodes within the 24-h observation
period, the emesis was considered severe (9).
Our primary efficacy end-point was complete response, defined as patients who stayed completely
free from PONV and had no rescue antiemetic requirement during the first 24-h observation period.
Pain intensity was rated by the patients using an
11-point numerical rating scale similar to that used for
nausea, where 0 symbolized no pain and 10 represented the worst pain imaginable. At the end of the
observation period, all patients would be asked
whether they were satisfied with the PCA procedure.
The satisfaction on PCA was also assessed using the
similar 11-point numerical rating scale. A score of
10 denoted the highest level of satisfaction, and patient satisfaction was defined as high if the score was
8 or more (10).
The severity of sedation was classified into 5 categories: 0 fully awake; 1 drowsy, closed eyes; 2
asleep, rousable; 3 asleep, unrousable, answer to
touch or pain; 4 does not respond. Other side effects
such as restlessness (felt nervous or jumpy), visual
disturbance, headache, or extrapyramidal symptoms
were also considered at 2, 12, and 24 h
postoperatively.
Sample size calculation was performed before starting the trials by using a statistical power analysis.
Based on an error of 0.05 and error of 0.20, 30
patients were estimated to be needed in each group to
have a 90% chance with an error of 5% to detect a
decrease in total PONV incidence from 60% to 40%
after treatment (11). To compensate for patients not
completing the study, we randomized 40 patients to
each group. Data were analyzed using one-way analysis of variance with a linear contrast, 2 test with
Yates correction, and Mann-Whitney U-test as appropriate. Data are expressed as mean values with sd or
number and percentage. A P value 0.05 was considered statistically significant. Commercial software
SPSS 10.0 (SPSS Inc., Chicago, IL) for Windows was
used for data processing.

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ANESTH ANALG
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Table 1. Clinical Characteristics, Surgical Types, and Duration of Anesthesia

Dexamethasone Dexamethasone Dexamethasone Dexamethasone Droperidol
12 mg (n 38) 8 mg (n 36) 4 mg (n 38) 2 mg (n 36)
(n 37)
Age (yr)
Weight (kg)
Risk factors
Previous PONV
Motion sickness
Nonsmoker
Surgical type
Orthopedic
General
Gynecologic
Duration of anesthesia (min)

Saline
(n 35)

51 15
51.4 7.4

54 12
52.5 6.8

55 16
52.8 7.3

53 13
53.2 7.4

53 14
51.7 8.3

52 12
53.6 7.6

9 (23.7)
18 (47.4)
35 (92.1)

7 (19.4)
16 (44.4)
34 (94.4)

6 (15.8)
19 (50.0)
35 (92.1)

9 (25.0)
20 (55.6)
38 (88.4)

10 (27.0)
19 (51.4)
34 (91.9)

8 (22.9)
15 (42.9)
32 (88.6)

12 (31.6)
13 (34.2)
13 (34.2)
143 29

11 (30.6)
15 (41.7)
10 (27.8)
138 31

12 (31.6)
14 (36.8)
12 (31.6)
148 23

10 (27.8)
15 (41.7)
11 (30.6)
150 33

13 (35.1)
12 (32.4)
12 (32.4)
145 35

10 (28.6)
14 (40.0)
11 (31.4)
135 28

Values are mean sd or number (percentage). No significant differences among groups.

PONV postoperative nausea and vomiting.

Results
A total of 240 patients were recruited. Among these
patients, 20 were later withdrawn for comparisons for
the following reasons: 2 patients in the droperidol
group experienced excessive drowsiness and PCA had
to be discontinued; 2 patients underwent further surgery within 24 h; 6 patients had difficult intubation;
and 10 patients had inadequate follow-up. The remaining 220 patients completed this study. Patient
characteristics, surgical types, duration of anesthesia,
and numbers of risk factors for PONV (12), including
prior PONV, motion sickness, and nonsmokers, were
similar in the 6 groups (Table 1).
The incidence of PONV, pain scores, morphine consumption, and sedation categories in each group in the
0 to 2 h, 2 to 12 h, and 12 to 24 h postoperatively are
reported in Table 2. The incidence of PONV in the
dexamethasone 8 mg and 12 mg and droperidol
groups were significantly less frequent at all times
than those of dexamethasone 2 mg and saline groups.
No difference was found between dexamethasone
8 mg and 12 mg and droperidol groups. Patients in the
6 groups reported similar low pain scores for each
time interval, and there was no significant difference
in morphine consumption. The levels of sedation were
not different among the groups. Yet, 2 patients in the
droperidol group were asleep and only responded to
touch (sedation category 3) and 4 patients experienced
restlessness at 24 h postoperatively. At the end of the
study period, no other side effects were observed in
any of the groups.
Figure 1 shows the number of patients in mild (nausea score 13), moderate (nausea score 4 7) and severe
(nausea score 8 10) nausea category and emesis episodes in the 6 groups during the first 24 h observatory
period. The severity of nausea was no statistically
different among groups. Yet, patients in the dexamethasone 8 and 12 mg and droperidol groups reported a less frequent incidence of severe emesis

(emetic episodes 4; P 0.046, 0.041, and 0.011 respectively) than did those in the saline group.
Table 3 demonstrates complete response rate (no
PONV, no rescue antiemetic), the requirements of rescue antiemetic, morphine consumption, and patient
satisfaction during the 24 h observation period. Patients who received dexamethasone 8 and 12 mg and
droperidol produced a significantly higher complete
response rate (P 0.017, 0.002, and 0.001 respectively), less requirements for rescue antiemetics (P
0.011, 0.004 and 0.001 respectively), and higher satisfaction scores (P 0.043, 0.035, and 0.001 respectively)
than did those who received saline in the first 24 h
after anesthesia (Table 3). In addition, significantly
more patients treated with dexamethasone 8 or 12 mg
or droperidol rated the experience as highly satisfactory (satisfaction score 8) in comparison to those
who received placebo (P 0.033, 0.019, and 0.004
respectively). No significant differences were found
among the dexamethasone 8 and 12 mg and droperidol groups. Dexamethasone 2 and 4 mg provided no
better PONV protection than saline alone. The morphine consumption was not different among groups.

Discussion
Many published articles have suggested the use of
dexamethasone as a prophylactic antiemetic for
PONV (6). Investigations have shown that the onset
time of dexamethasone on antiemesis is approximately 2 h (5), and its biological half-life is 36 to 72 h
(13). Thus, the delayed emesis (i.e., up to 24 h) is better
controlled with dexamethasone compared with classic
antiemetics (6,14). Most patients receiving PCAmorphine vomited in the first 1224 h postoperatively
(15). Hence, in this study, dexamethasone was administered immediately before the induction of anesthesia
and the data were collected in the first 24 h postoperatively. We found that 57% of patients in the saline

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Table 2. Incidence of Postoperative Nausea and Vomiting, Morphine Consumption, Postoperative Pain Scores, and
Sedation Categories During Different Observatory Periods
Droperidol
Dexamethasone Dexamethasone Dexamethasone Dexamethasone 0.1 mg/mL
12 mg (n 38) 8 mg (n 36) 4 mg (n 38) 2 mg (n 36)
(n 37)
02 h
Nausea
Emesis
Total
Morphine consumption (mg)
Pain scores
Sedation (0/1/2/3/4)
212 h
Nausea
Emesis
Total
Morphine consumption (mg)
Pain scores
Sedation (0/1/2/3/4)
1224 h
Nausea
Emesis
Total
Morphine consumption (mg)
Pain scores
Sedation (0/1/2/3/4)

Saline
(n 35)

3 (7.9)
2 (5.3)
5 (13.2)*
10 5
2.5 1.2
30/8/0/0/0

3 (8.3)
3 (8.3)
5 (13.9)*
12 4
2.6 0.8
29/7/0/0/0

5 (13.2)
3 (7.9)
8 (21.1)
11 5
2.3 1.1
29/8/1/0/0

7 (19.4)
6 (16.7)
13 (36.1)
12 6
2.4 1.0
28/8/0/0/0

2 (5.4)
7 (20)
2 (5.4)
6 (17.1)
4 (10.8)*
13 (37.1)
10 6
11 4
2.5 0.9
2.6 1.0
29/7/1/0/0 27/8/0/0/0

2 (5.3)
2 (5.3)
4 (10.5)*
86
2.2 0.9
34/4/0/0/0

3 (8.3)
2 (5.6)
5 (13.9)*
94
2.4 1.3
34/2/0/0/0

5 (13.2)
4 (10.5)
9 (23.7)
75
2.0 1.2
35/3/0/0/0

8 (22.2)
6 (16.7)
15 (41.7)
10 4
2.1 1.1
33/3/0/0/0

2 (5.4)
7 (20)
2 (5.4)
7 (20)
4 (10.8)*
14 (40)
85
95
2.0 0.8
2.2 1.2
30/5/2/0/0 32/3/0/0/0

2 (5.3)
1 (2.6)
3 (7.9)*
74
1.9 1.1
36/2/0/0/0

1 (2.8)
2 (5.6)
3 (8.3)*
83
1.8 0.8
35/1/0/0/0

3 (7.9)
3 (7.9)
6 (15.8)
74
1.8 0.9
35/3/0/0/0

5 (13.9)
5 (3.9)
10 (27.8)
93
2.0 0.8
35/1/0/0/0

1 (2.7)
5 (14.3)
2 (5.4)
5 (14.3)
3 (8.1)*
10 (28.6)
75
75
1.9 0.9
1.8 0.8
31/3/1/2/0 33/2/0/0/0

Values are mean sd or number (percentage).

Sedation categories: 0 fully awake; 1 drowsy, closed eyes; 2 asleep, rousable; 3 asleep, unrousable, answer to touch or pain; 4 does not respond.
P 0.05 compared with * saline group, droperidol group, and dexamethasone 2 mg group.

Figure 1. The number of patients having nausea and vomiting

during the first 24 h observatory period in patients receiving 12
(D12), 8 (D8), 4 (D4), or 2 (D2) mg of dexamethasone, or droperidol
(Droperidol) or saline (Saline) control. *P 0.05.

control group reported nausea and/or vomiting during the first 24 h after anesthesia. After receiving dexamethasone 8 and 12 mg during induction, the incidence of PONV was reduced significantly to 27.8%
and 21.1% respectively. Dexamethasone 2 and 4 mg
were ineffective for this purpose.
Study designs that analyze only one type of surgery
or restricted patient populations have recently been

criticized (16,17). In fact, large prospective investigations have shown that the different incidences of
PONV are mainly caused by the associated risk factors
and less by the operation itself (17). Therefore, we
used Apfels simplified risk score instead of selecting
patients undergoing just one type of surgery to identify patients with an increased risk. In this study, the
types of surgery and the number of risk factors were
similar among groups (Table 1). We believe that the
difference in the six groups with respect to PONV was
directly related to the drug tested. We also found that
the incidence of PONV in the droperidol and salinecontrolled groups were comparable with previously
published data (1,4).
Droperidol is effective in reducing the incidence of
PONV when given concomitantly with a PCA device
with morphine (1,4). However, the side effects in the
postoperative setting remains a concern even when
antiemetic treatment with droperidol is administered
in small doses (18 20). Lamond et al. (4) found that
these previous patients were administered an initial
loading bolus dose of droperidol as part of the anesthetic technique, with the result that patients often
received large doses of droperidol. Gan et al. (21)
noted that administration of an initial loading dose of
droperidol before addition of droperidol in PCA
should be avoided, as it resulted in more sedation.
Lamond et al. (4) demonstrated that when given without an initial loading dose, a PCA bolus dose of

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Table 3. Complete Response (no PONV, no Rescue Antimetic), Requirement for Rescue Antimetics, Pain Score and
Patient Satisfaction in the First 24 h Postoperatively
Groups

Complete response
Rescue antiemetics
Morphine consumption
Satisfaction score
Satisfaction score 8

Dexamethasone
12 mg (n 38)

Dexamethasone
8 mg (n 36)

Dexamethasone
4 mg (n 38)

30 (78.9)*
5 (13.2)*
37.3 15.5
7.5 1.6*
24 (63.2)*

26 (72.2)*
6 (16.7)*
38.6 14.6
7.4 1.5*
22 (61.1)*

22 (57.9)
12 (31.6)
35.8 12.2
6.9 1.4
17 (44.7)

Droperidol
Dexamethasone 0.1 mg.ml1
2 mg (n 36)
(n 37)
15 (41.7)
17 (47.2)
32.4 16.3
6.6 1.3
12 (33.3)

30 (81.1)*
4 (10.8)*
36.5 15.8
7.7 1.6*
26 (70.3)*

Saline
(n 35)
15 (42.9)
16 (45.7)
31.2 16.7
6.1 2.3
12 (34.3)

Values are mean sd or number (percentage).

P 0.05 compared with * saline group, droperidol group, and dexamethasone 2 mg group.
Complete response no postoperative nausea and vomiting, no rescue emetic.

droperidol of 0.1 mg/mL appears to provide the optimal balance between antiemetic efficacy and an acceptable incidence of side effects. In the current study,
we found that a total dose of droperidol of between 2.0
and 5.3 mg in 24 h was associated with an acceptable
rate of PONV (18.9%), which was similar to dexamethasone 8 and 12 mg. The levels of sedation were not
different among groups, although the small size of the
groups could also be the cause. Nevertheless, one in
six patients (6 of 37 patients) in the droperidol group
reported side effects at 24 h after operation. Four of
these patients had restlessness, a common droperidolrelated side effect, after administration of 35, 36, 40,
and 43 mg of morphine (3.5, 3.6, 4.0, and 4.3 mg
droperidol) respectively. None of these patients found
the experience disturbing. However, PCA treatment
had to be stopped in 2 patients after administration of
total doses of 42 and 51 mg morphine (4.2 and 5.1 mg
droperidol) because of being asleep and only awakened by touch. We could not establish whether the
symptoms were caused by the droperidol, the morphine, or the combination of the two. However, Roberts et al. (19) found a significant increase in sedation
associated with PCA droperidol. Trame`r and Walder
(1) also noted that adverse events are likely when the
droperidol dosage exceeds 4 6 mg per day. Of note is
that these side effects were not reported in any of the
dexamethasone-treated patients.
Droperidol has been used for the prophylaxis and
treatment of PONV for over 30 years (22). On December 5, 2001, the US Food and Drug Administration
issued a black box warning regarding the risk of
cardiac arrhythmias during droperidol administration
(23). However, White et al. (22) stated that there is not
even a single case report indicating that droperidol in
doses used for the management of PONV has been
associated with cardiac arrest or arrhythmias. After
conducting an extensive literature research, we were
also unable to find a report of arrhythmias or cardiac

arrest associated with the use of droperidol with morphine PCA. In fact, continuing 12-lead electrocardiogram (ECG) monitoring for all elective surgery patients during the postoperative PCA period is
clinically impractical. Thus, patients in the droperidol
group in the current study were not monitored by
continuous ECG in ward. Although no discernible
cardiac arrhythmia accompanying 0.1 mg/mL
droperidol in the PCA was found, further detailed
investigation and a longer follow-up would be needed
to prove this.
Baxendale et al. (24) reported that dexamethasone
might reduce pain intensity after tooth extraction. In
this study, we found that both morphine consumption
and pain severity were similar in the dexamethasone
and saline control groups. These results indicate that
dexamethasone might not alter the intensity of pain
after surgery, nor did it enhance the efficacy of
PCA-morphine.
Patient satisfaction should be an important consideration in antiemetic selection for PONV treatment.
Fisher (25) indicated that patient satisfaction, rather
than PONV, should be advocated as the main outcome. In this study, a higher satisfaction score was
reported for patients treated with dexamethasone 8 or
12 mg or droperidol in comparison with those who
received saline. Further, more than half of the subjects
in these groups (dexamethasone 8/12 mg, 61.1/63.2%;
droperidol, 70.3%) were highly satisfied (satisfaction
score 8). With a similar pain score at all times in the
6 groups, we believe that the degree of satisfaction
was mainly associated with the severity and incidence
of PONV during PCA. Hence, dexamethasone 8 or
12 mg IV not only reduced the incidence of PCArelated PONV, but also provided a similar level of
patient satisfaction as droperidol treatment.
In this study, patients who received dexamethasone
8 or 12 mg or droperidol had less frequent incidence of
nausea than those who received saline (Table 2). However, the differences were not statistically significant.

ANESTH ANALG
2004;98:1066 71

The a priori defined outcome in this study was the total

incidence of PONV and the sample size estimation
assumed to be 60%. As the incidence of nausea in the
saline group was significantly less (25.7%) than this
estimation, the power of the study to detect such
differences was not sufficient. Thus, more patients
were needed to detect the same relative reduction in
nausea.
Although complications from corticosteroid use,
such as delayed healing, additional wound infection,
peptic-ulcer perforation, or adrenal suppression, are
usually related to its long-term therapy, we avoided
its use in patients who were immunosuppressed or
who had peptic ulcer disease, diabetes, Cushings syndrome, or recent tuberculosis to minimize the risk of
exacerbating their underlying diseases. In previous
studies, a single dose of dexamethasone was considered safe (37,10). In this study, no apparent adverse
effects, such as peptic ulcer perforation, were noted.
However, we do not know if a single dose of dexamethasone would suppress adrenal function or have
clinical significance (for instance, if it would increase
the risk of wound infection) in healthy patients during
surgical stress. This needs to be studied further.
In conclusion, this study has demonstrated that the
preinduction administration of dexamethasone 8 mg
IV was the smallest effective dose for the reduction of
PCA morphine-related PONV. Moreover, this was as
effective as adding droperidol 0.1 mg/mL to the morphine PCA without causing drowsiness, restlessness,
or arrhythmias.

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