Asian Journal of Anesthesiology xxx (2017) 1e5

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Asian Journal of Anesthesiology

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Research paper

Effect of intermediate dose dexamethasone on post-operative pain in

lumbar spine surgery: A randomized, triple-blind, placebo-controlled
trial
Aumjit Wittayapairoj a *, Kriangkrai Wittayapairoj b, Atiporn Kulawong a,
Yuwadee Huntula a
a
Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
b
Department of Orthopedics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

a r t i c l e i n f o a b s t r a c t

Article history: Objectives: Dexamethasone has demonstrated analgesic properties and is used as an adjunctive pain
Received 6 June 2017 agent for many procedures. We evaluated the efcacy of a single, intermediate dose of dexamethasone
Received in revised form on post-operative analgesic consumption, and pain scores for lumbar spine surgery.
22 August 2017
Methods: Eighty patients aged between 18 and 70 scheduled for lumbar decompressive laminectomy
Accepted 24 August 2017
were randomly allocated into two groups to receive either intravenous 0.2 mg/kg dexamethasone (group
D 40) or normal saline (group P 40) before anesthetic induction. Post-operative total morphine
Keywords:
consumption and the respective pain score at the PACU, 4, 6, 12, 24 and 48 h were evaluated. In addition,
Analgesic effect;
Decompressive laminectomy;
any adverse events were recorded.
Dexamethasone; Results: Total post-operative morphine consumption within 48 h was signicantly lower in group D (34.5
Postoperative pain; vs. 42.5 mg, p 0.031); however, the respective morphine consumption at each assessment was similar
Spine surgery between groups. The respective NRS pain score at rest and upon movement in both groups was not
signicantly different for any time comparison. The average NRS pain score at rest and upon movement
within 48 h was similar in both groups (i.e., NRS at rest Group D 3.6 vs. Group P 3.8, p 0.936, and NRS
for movement Group D 6.2 vs. Group P 6.3, p 0.791). The adverse events within 48 h were also similar
and serious complications (i.e., respiratory depression or surgical infection) were not found in either
group.
Conclusion: A single, intermediate dose of dexamethasone before anesthetic induction could minimally
decrease post-operative morphine consumption within 48 h after lumbar decompressive laminectomy
without any effect on the pain score.
2017 Taiwan Society of Anesthesiologists. Published by Elsevier Taiwan LLC. This is an open access
article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

1. Introduction development of chronic pain, which is more difcult to treat, thus

Spine surgery is a major orthopedic procedure, often resulting in
severe acute post-operative pain, which is challenging to man-
age.1e3 Inadequate pain control can lead to several poor outcomes,
including lung atelectasis, pneumonia, delayed ambulation, and
prolonged hospital stay.3,4 An increase in catecholamine and
cortisol levels can, moreover, cause cardiac ischemia and suppress
the immune system, especially among the critically ill and elderly.2
Improper acute pain management is also associated with the
* Corresponding author. Department of Anesthesiology, Faculty of Medicine,
Khon Kaen University, Khon Kaen, 40002, Thailand. Fax: 66 43348390x405.
E-mail: aumjit@kku.ac.th, aumjit69@yahoo.com (A. Wittayapairoj).
eroding quality of life.1
Opioids are effective and potent analgesics; however, various
side effects occur when high doses of opioids are used (i.e., nausea,
vomiting, itching, gastrointestinal and bladder dysfunction,
drowsiness, and respiratory depression).5
There is currently no consensus on the best techniques for the
management post-operative pain; however, a multimodal anal-
gesia approach using a combination of analgesic agents could
improve the efcacy of pain control while reducing post-operative
opioid consumption and their common and dangerous side
effects.3,4,6
A previous meta-analysis revealed that an intermediate dose
(0.1e0.2 mg/kg) of dexamethasone signicantly decreases post-

https://doi.org/10.1016/j.aja.2017.08.001
2468-824X/ 2017 Taiwan Society of Anesthesiologists. Published by Elsevier Taiwan LLC. This is an open access article under the CC BY-NC-ND license (http://
creativecommons.org/licenses/by-nc-nd/4.0/).

Please cite this article in press as: Wittayapairoj A, et al., Effect of intermediate dose dexamethasone on post-operative pain in lumbar spine
surgery: A randomized, triple-blind, placebo-controlled trial, Asian Journal of Anesthesiology (2017), https://doi.org/10.1016/j.aja.2017.08.001
2 A. Wittayapairoj et al.
operative opioid consumption and pain scores for many surgical
procedures (e.g., breast, thyroid, and laparoscopic surgery).7 After
conducting various minor and major orthopedic procedures, glu-
cocorticoids (i.e., betamethasone, methylprednisolone, and dexa-
methasone) have had an observable analgesic effect8e13; however,
there have been only few studies on the effect of dexamethasone on
spine surgery and the direct analgesic effect of an intermediate
dose of dexamethasone on spine surgery has yet to be evaluated.
We hypothesized that a single, intermediate dose of dexa-
methasone would ameliorate the post-operative analgesic effect
after spine surgery in terms of decreased post-operative opioid
consumption and pain score.
2. Methods
This controlled, randomized, triple blind study was approved by
our Institutional Review Board and was conducted in accordance with
Good Clinical Practices and the Declaration of Helsinki. The study was
registered at www.clinicaltrials.in.th (No. TCTR20160830001). We
followed the CONSORT recommendations for reporting randomized,
controlled clinical trials (Fig. 1).
After obtaining written informed consent from all participants,
we enrolled 90 patients of either sex, between 18 and 70 years of
age. We included participants who (a) had an ASA physical status of
between 1 and 3; (b) were scheduled for elective lumbar spine
decompressive laminectomy under general anesthesia; and, (c)
could operate a patient-controlled analgesic (PCA) device. We
excluded patients who (a) had undergone more than three levels of
laminectomy; (b) had any known allergy or contraindication to
dexamethasone; (c) had received chronic steroid or opioids; or, (d)
had severe hepatic or renal impairment, previous lumbar spine
surgery, pregnancy or lactation, and diabetic mellitus.
All participants were instructed how to assess pain using a
numeric rating scale pain score (NRS), ranging from 0 no pain to
10 the worst possible pain, and on how to operate a PCA device.
The patients were randomized into 2 groups: the dexametha-
sone group (Group D 40 patients) and the placebo group (Group
P 40 patients), using block of four randomization with a
Fig. 1. Flow diagram (n number of patients).
Please cite this article in press as: Wittayapairoj A, et al., Effect of intermediate dose dexamethasone on post-operative pain in lumbar spine
surgery: A randomized, triple-blind, placebo-controlled trial, Asian Journal of Anesthesiology (2017), https://doi.org/10.1016/j.aja.2017.08.001
computer generated random number (http://www.randomizer.
org/). The sequential random number code was enclosed in a
sealed opaque envelope. To ensure blinding, we (a) assigned a
nurse not involved in the process of patient evaluation to prepare
the study drug solution according to the code and kept the
randomization code condential until the data were analyzed; and,
(b) masked all patients, physicians, and data recorders to the group
allocation.
The study drug for both groups was prepared and appeared to
be the same clear solution. For group D, we prepared dexametha-
sone (Lordexa L.B.S. Laboratory LTD. Bangkok, Thailand) 0.2 mg/
kg, mixed in normal saline (0.9%) to a nal volume of 5 mL. Normal
saline (0.9%) was used to prepare the placebo for group P.
In the operating room, all patients were monitored as per
standard general anesthesia, including electrocardiogram, non-
invasive blood pressure, pulse oximetry, and end-tidal partial
pressure of carbon dioxide (EtCO2). Before induction, the study
drug solution was injected. The anesthetic techniques were stan-
dardized in all groups. Anesthesia was induced with propofol
(2 mg/kg) and fentanyl (1.5 mg/kg). Orotracheal intubation was
facilitated with cisatracurium 0.2 mg/kg. Maintenance of anes-
thesia was done with sevourane in a mixture of 60% nitrous oxide
and 40% oxygen, and 0.5 mg/kg of fentanyl as needed. No other
analgesic drugs were administered within 48 h after surgery.
The surgery was performed using standardized surgical tech-
niques among the 3 experienced spinal surgeons. After the surgery,
all of the patients were evaluated and extubated as soon as they
met the criteria and morphine sulphate 2 mg was given intrave-
nously before they left the operating room.
Upon arrival at the post anesthetic care unit (PACU), all of the
patients received the same post-operative pain control protocol.
PCA devices were provided and discontinued 48 h after surgery.
Fifty milliliters of PCA solution containing 1 mg/mL morphine was
prepared and programmed as 1 mg per dose. The lockout interval
was 5 min, with a 1-h limit of 10 mg.
The primary outcome was post-operative morphine consump-
tion from the PCA device at the PACU, 4, 6, 12, 24 and 48 h. The
secondary outcomes were the post-operative NRS pain score at rest
Effect of dexamethasone on post-operative pain in spine surgery 3

and upon movement. We also recorded any adverse events, There were no signicant differences among times between the
including respiratory depression (respiratory rate < 8 breaths/min), two groups in terms of NRS pain score at rest or upon movement
sedation, nausea, vomiting and surgical site infection. Respiratory (Table 2). The respective average NRS pain score at rest or upon
depression and surgical site infection were recorded as Yes or No. movement within 48 h between groups was also not signicantly
Sedation was scored: 0 fully conscious, 1 mild sedation, different (Table 3). Adverse events within 48 h were also similar
2 marked sedation, 3 cannot wake-up. Nausea and vomiting and serious complications (viz., respiratory depression and surgical
were scored as 0 no symptoms, 1 mild, 2 need treatment, and site infection) were not found in either group (Table 4).
3 need treatment more than once.
The statistical analysis was based on a repeated measures design 4. Discussion
with each subject being measured 6 times. According to previous
study,14 a sample size of at least 35 patients in each group was Our results demonstrated the analgesic effect of intermediate-
required to have 80% power for detecting a 15 mg difference in dose dexamethasone on spinal surgery in terms of decreasing 48-
morphine consumption (a 0.05) for a two-sided comparison test. h post-operative morphine consumption, this result corresponds
To compensate for possible patient drop-outs, we planned to re- with many previous studies.11,12,15e21; however, based on the
cruit 80 patients. overall evaluation within 48 h, there was only an 18.8% mean
Demographic variables were presented as means and standard reduction in morphine consumption, which is a modest reduction
deviations for continuous parametric data and medians with of clinically relevant factors (Table 3).
ranges for the nonparametric data. Categorical variables were re- We did not observe any signicant difference between groups in
ported as proportions. All continuous variables were tested for the NRS pain score whether at rest or upon movement perhaps
normality using a normal qeq plot. because post-operative pain management was provided by intra-
The respective total morphine consumption and pain score be- venous morphine via the PCA technique, which allows the patient
tween groups was compared at each time point, using the Student to operate and receive the optimal dose of morphine to make them
t-test or the ManneWhitney U statistics as appropriate. Repeated feel comfortable. A similar result was previously reported in two
measures analysis of variance using the generalized estimating other studies.17,20
equation model was used to account for correlations among ob- The analgesic mechanism of action of dexamethasone could be
servations from the same subject over time with respect to that it (a) causes inhibition of production of inammatory media-
morphine doses and pain scores. tors (i.e., prostaglandin and bradykinin), (b) prevents reduction in
The end-point data were analyzed on an intention-to-treat basis the pain threshold that can occur because of surgery, (c) reduces
using STATA version 10.0 software (Stata, Collage Station, TX). tissue swelling because of anti-inammatory effects, and (d) in-
hibits nerve compression by inammatory tissue.15,22e24
3. Results A meta-analysis demonstrated, intermediate- to high-dose
dexamethasone has an implicit analgesic efcacy in various pro-
Ninety patients met the eligibility criteria, but 7 refused to cedures whereas a low dose has only an anti-emesis effect.7 The
participate, 2 others were taking NSAIDs intraoperatively, and 1 analgesic effect for a major procedure, however, remains uncertain.
had the operation cancelled. Thus, 80 patients were enrolled and According to a systematic review by Holte and Kehlet,24 an anal-
randomized into 2 groups; 40 to the dexamethasone group (D) and gesic effect was not observed in major abdominal surgery after
40 to the placebo group (P). All of the participants were followed up glucocorticoid administration whereas for many less extended
and assessed on an intention-to-treat basis (Fig. 1). The baseline surgeries, especially dental procedures, substantially reduced
characteristics and surgical data were summarized and there was postoperative pain was achieved.
no signicant difference between groups (Table 1). Liu et al.15 similarly reported that 10 mg dexamethasone given
Post-operative total morphine consumption was lower in group intravenously during induction in major gynecological surgery
D for all 6 time assessments but without any statistically signicant provided only minimal pain reduction. Lee et al.25 studied major
differences among times (Table 2). Cumulative morphine con- orthopedic surgery including corrective spinal surgery, hip
sumption within 48 h in group D was signicantly lower than group arthroplasty, and knee arthroplasty and did not nd any effect of
P (34.5 vs. 42.5 mg, mean difference 8.0, p value 0.031) dexamethasone on pain intensity or postoperative morphine con-
(Table 3). sumption. A systematic review and meta-analysis by Waldron
et al.26 including 5796 patients given 1.25e20 mg dexamethasone
Table 1 in a single-dose intravenously showed a small analgesic effect of
Baseline characteristics and surgical data. dexamethasone on pain score and opioid consumption. Taken
Characteristics Group D Group P together, we hypothesized that dexamethasone might only be
Sex (male/female) 16/24 16/24
benecial for less extensive procedures and have a relatively small
Agea (years) 58.8 6.1 (39e67) 57.18 8.1 (31e70) inuence on extensive and invasive procedures. Thus there would
Weighta (kg) 62.7 9.3 (48e90) 67.5 13.9 (42e95) be a relatively small analgesic effect of dexamethasone on major
Heighta (cm) 157.6 7.0 (142e177) 160.8 7.7 (150e177) procedures such as spine surgery as in our study.
Body mass 24.9 3.0 (17e34) 26.0 4.3 (19e36)
The timing of dexamethasone administration might be
indexa (kg/cm2)
ASA physical 12/26/2 13/26/1 another important issue. In the current study, we administered
status: 1/2/3 dexamethasone before anesthetic induction based on the two
Operative timea (min) 82.3 44.9 (30e240) 86.5 39.7 (30e210) previous clinical trials. Jokela et al.17 and Bagchi et al.27 demon-
Number levels 9/21/10 8/21/11
strated that dexamethasone administered just before induction
treated:1/2/3
Intraoperative blood 248.2 203.7 (10e1000) 281.3 321.3 (20e1500)
can reduce pain intensity during tonsillectomy and laparoscopic
lossa (mL) hysterectomy. Some studies, however, debate this. For example,
Intraoperative fentanyl 132.5 38.9 (75e250) 134.8 52.0 (50e340) Waldron et al.26 demonstrated that pre-operative rather than
usagea (mg) intra-operative administration of dexamethasone was more
ASA indicates American Society of Anesthesiologists. effective in reducing 24 h pain scores. Similarly, Thue et al.19 and
Holte and Kehlet24 suggested that dexamethasone should be
a
Values given as mean standard deviation (minimumemaximum).

Please cite this article in press as: Wittayapairoj A, et al., Effect of intermediate dose dexamethasone on post-operative pain in lumbar spine
surgery: A randomized, triple-blind, placebo-controlled trial, Asian Journal of Anesthesiology (2017), https://doi.org/10.1016/j.aja.2017.08.001
4 A. Wittayapairoj et al.

Table 2
Morphine consumption, NRS pain scores at rest, and upon movement.

Group Da (n 40) Group Pa (n 40) Mean differenceb(95% CI) % reductionc (95% CI) p value

MO consumption (mg)
- PACU 5.8 (3.4) 6.0 (2.5) 0.2 (1.1e1.5) 3.3 (19.0e25.6) 0.093
- 4h 7.7 (3.8) 10.5 (4.8) 2.8 (0.8e4.7) 26.5 (7.7e45.0) 0.058
- 8h 6.7 (4.1) 8.3 (4.5) 1.6 (0.4e3.4) 18.1 (5.2e41.4) 0.349
- 12 h 5.6 (3.5) 6.9 (3.6) 1.3 (0.2e2.9) 19.7 (3.1e42.0) 0.476
- 24 h 4.3 (2.8) 5.1 (3.2) 0.7 (0.6e2.1) 15.0 (11.7e42.0) 0.701
- 48 h 4.2 (4.7) 5.6 (5.4) 1.4 (0.8e3.6) 24.9 (15.8e65.6) 0.358
Pain at rest (0e10)
- PACU 5.7 (2.7) 5.9 (2.8) 0.2 (1.1e1.3) 2.2 (19.1e23.4) 0.923
-4 h 4.5 (2.8) 4.4 (3.0) 0.1 (1.3e1.2) 1.3 (30.8e28.6) 0.472
- 8h 3.6 (2.2) 3.9 (2.5) 0.3 (0.8e1.3) 6.7 (20.7e33.6) 0.999
- 12 h 3.6 (2.3) 3.3 (2.2) 0.3 (1.4e0.6) 11.2 (42.1e19.2) 0.107
- 24 h 2.6 (2.0) 3.1 (2.0) 0.5 (0.3e1.4) 18.2 (10.5e46.6) 0.154
- 48 h 1.8 (1.9) 2.1 (1.9) 0.3 (0.4e1.2) 17.4 (22.5e56.9) 0.499
Pain on movement (0e10)
- PACU 8.0 (2.2) 8.1 (2.4) 0.1 (0.9e1.1) 0.8 (11.7e13.6) 0.437
- 4h 6.9 (2.7) 6.8 (3.0) 0.1 (1.4e1.2) 1.5 (20.4e17.4) 0.337
- 8h 6.4 (2.5) 6.5 (2.2) 0.1 (0.9e0.8) 0.9 (15.6e17.1) 0.458
- 12 h 5.9 (2.0) 6.0 (1.9) 0.1 (0.9e0.8) 1.0 (15.6e13.9) 0.832
- 24 h 5.4 (1.7) 5.8 (2.2) 0.4 (0.4e1.4) 8.5 (6.2e23.2) 0.233
- 48 h 4.4 (1.8) 4.6 (1.9) 0.2 (0.6e1.0) 3.9 (14.6e22.2) 0.736

Comparison between groups used Student t-test.

CI condence interval; MO morphine; SD standard deviation.
a
Data presented as means (SD).
b
Mean difference (95% CI) calculated from (mean group P  mean group D).
c
% reduction (95% CI) calculated from [(mean group P  mean group D)/mean group P]  100%.

Table 3
Morphine consumption, NRS pain scores at rest and upon movement within 48 h.

Group Da (n 40) Group Pa (n 40) Mean differenceb (95% CI) p value

Morphine consumption (mg) 34.5 (14.4) 42.5 (14.3) 8.0 (1.6e14.4) 0.031*
Pain at rest (0e10) 3.6 (1.5) 3.8 (1.4) 0.1 (0.5e0.8) 0.936
Pain at movement (0e10) 6.2 (1.3) 6.3 (1.2) 0.1 (0.5e0.7) 0.791

Comparison between groups used Student t-test.

*p value < 0.05 statistically signicant difference.
a
Data presented as means (SD).
b
Mean difference (95% CI) calculated from (mean group P e mean group D).

administered earlier than just before induction to gain the which would explain the relatively small analgesic effect of dexa-
maximal effect. methasone in our study.
Glucocorticoids must diffuse across the cell membrane in order We conrmed the safety of single, intermediate-dose dexa-
to alter gene transcription and protein synthesis. This process takes methasone as per previous studies7,17e20,29; whereas Waldron26
1e2 h, hence the onset time of dexamethasone.23,28 Relatedly, the found an increase in blood sugar compared to the control group
activation of early mediators of the metabolic response to injury without any correlation to surgical wound infection. Knowing this,
occur immediately after the surgical incision, so administration of we excluded diabetics to ensure patient safety.
dexamethasone should be at least 1 h before surgery to achieve the We did not observe any differences between groups in the
maximal effect of the drug and to minimize pain and inammation. incidence of PONV and sedation; however, the PONV and sedation
In our study, dexamethasone was injected just before anesthetic scores were higher in the placebo group, corresponding to a higher
induction (usually 30e40 min before skin incision) which may have dose of total morphine consumption as used by the placebo group
been too late to achieve the maximal effect of dexamethasone, (Table 4).
The strength of our study is that this is the rst triple-blinded,
clinical trial to evaluate intermediate-dose dexamethasone for its
Table 4 analgesic effect on spine surgery. We, however, only investigated
Adverse events in 48 h.
single-dose and single time administration of dexamethasone.
Adverse event Group Da Group Pa Risk ratio p value Future studies should focus on different administration time points
(n 40) (n 40) (95% CI) and different doses.
Sedationb 6 (15.0) 11 (27.5) 0.6 (0.2e1.3) 0.17 In conclusion, single, intravenous, intermediate dose dexa-
Post-operative nausea 4 (10.0) 7 (17.5) 0.6 (0.2e1.8) 0.33 methasone before induction provided a modest decrease in post-
and vomiting (PONV)c
operative morphine consumption within 48 h of lumbar decom-
Respiratory depression 0 (0) 0 (0) NA NA
Surgical site infection 0 (0) 0 (0) NA NA
pressive laminectomy. Serious side effects were not observed.
a
Data presented as numbers (percentages).
b
Sedation: In group D, all cases who had event, have score of 1 whereas in group
P, the respective score was 2 and 1 (n 3 and 8, respectively).
Conicts of interest
c
PONV: In group D, all cases who had event, have PONV score of 1 whereas in
group P, the respective score was 2 and 1 (n 5 and 2, respectively). All contributing authors have no conicts of interest to declare.

Please cite this article in press as: Wittayapairoj A, et al., Effect of intermediate dose dexamethasone on post-operative pain in lumbar spine
surgery: A randomized, triple-blind, placebo-controlled trial, Asian Journal of Anesthesiology (2017), https://doi.org/10.1016/j.aja.2017.08.001
Effect of dexamethasone on post-operative pain in spine surgery
Acknowledgements
The authors thank (a) Dr. Jitjira Chaiyarit, statistician from the
Clinical Epidemiology Unit, Faculty of Medicine, Khon Kaen Uni-
versity for the statistical analysis; and (b) Mr. Bryan Roderick
Hamman for assistance with the English-language presentation of
the manuscript under the aegis of the Publication Clinic, Research
Affairs, Faculty of Medicine, Khon Kaen University.
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