Journal of Clinical Anesthesia (2016) 32, 127–133

Original Contribution

Comparison of postoperative analgesic efficacy of

intraoperative single-dose intravenous
administration of dexketoprofen trometamol and
diclofenac sodium in laparoscopic
cholecystectomy☆
Ali Anıl MD, Fatma Nur Kaya MD (Prof), Belgin Yavaşcaoğlu MD (Prof),
Esra Mercanoğlu Efe MD, DESA ⁎, Gürkan Türker MD (Prof), Abdurrahman Demirci MD
Uludağ University Medical Faculty, Department of Anesthesiology and Reanimation, Nilüfer Bursa Turkey

Received 17 November 2014; revised 1 February 2016; accepted 18 February 2016

Keywords:
Abstract
Analgesic efficacy;
Study objective: The aim of this study is to compare the effects of intravenous single-dose dexketoprofen
Dexketoprofen
trometamol and diclofenac sodium 30 minutes before the end of the surgery on relief of postoperative pain in
trometamol;
patients undergoing laparoscopic cholecystectomy.
Diclofenac sodium;
Design: A randomized fashion.
Laparoscopic
Setting and patients: Sixty (American Society of Anesthesiologist class I-II) patients undergoing
cholecystectomy
laparoscopic cholecystectomy were divided into 2 groups.
Intervention: Patients in group DT received 50 mg dexketoprofen trometamol, whereas patients in group
DS received 75 mg diclofenac sodium, intravenously 30 minutes before the end of surgery.
Measurements: Postoperative pain intensity, morphine consumption with patient-controlled analgesia, time
to first analgesic requirement, complications, rescue analgesic (intravenous tenoxicam 20 mg) requirement,
and duration of hospital stay were recorded.
Main results: Postoperative pain visual analog scale scores were similar in the follow-up periods (P N
.05). Patient-controlled analgesia morphine consumption was significantly less in group DT compared
with group DS in all postoperative follow-up periods (2 and 4 hours: P b .01; 8, 12, 18, and 24 hours: P b
.001). In the postoperative period, the first analgesic requirement time was significantly longer in
group DT compared with group DS (P b .01). In addition, the number of patients requiring
rescue analgesic was higher in group DS compared with group DT (P b .01). Other follow-up parameters
were similar.

☆
No conflict of interest.
⁎ Corresponding author. Tel.: +90 532 6454 040; fax: + 90 224 2954 232.
E-mail address: esramercan76@yahoo.com (E. Mercanoğlu Efe).

http://dx.doi.org/10.1016/j.jclinane.2016.02.020
0952-8180/© 2016 Elsevier Inc. All rights reserved.

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128 A. Anıl et al.

Conclusion: In our study, administration of intravenous single-dose dexketoprofen trometamol 30

minutes before the end of surgery provided effective analgesia with reduced consumption of opioids and
requirement for rescue analgesic compared with diclofenac sodium in patients undergoing laparoscopic
cholecystectomy. For this reason, we believe that, as a part of multimodal analgesia, dexketoprofen
trometamol provides more effective analgesia than diclofenac sodium in patients undergoing
laparoscopic cholecystectomy.
© 2016 Elsevier Inc. All rights reserved.

1. Introduction With this present study, it was aimed to investigate the

effects of intravenous single dose of dexketoprofen trome-
Postoperative pain is an acute phenomenon which starts with tamol and diclofenac sodium as a part of multimodal
surgical trauma and gradually decreases with wound healing. analgesia 30 minutes before the end of the surgery on relief
Inadequate postoperative pain management may lead to of postoperative pain in patients undergoing laparoscopic
negative consequences such as late mobilization, late discharge, cholecystectomy.
development of chronic pain, lower patient satisfaction,
prolonged recovery, and increased treatment costs [1].
Laparoscopic cholecystectomy is a frequently used surgical 2. Materials and methods
operation in treatment of gall stones. Pain intensity after
laparoscopic cholecystectomy is defined as mild to moderate Following approval from the Uludag University Ethics
[2,3]. Most of the patients suffer from severe abdominal and Committee and patient written informed consent, in a
shoulder pain in the early postoperative period of laparoscopic randomized fashion, 60 American Society of Anesthesiolo-
cholecystectomy and require strong analgesia like opioids, gists (ASA) class I-II patients between 18 and 75 years of age
nonselective anti-inflammatory drugs, selective cyclooxygen- undergoing laparoscopic cholecystectomy were included in
ase 2 inhibitors, and local anesthetic infiltration. our study and divided into 2 groups.
In recent years, multimodal analgesia method which Patients of ASA class III-IV and patients with hemor-
combines additive and synergistic effects of different rhagic diathesis, clotting disorder, history of hypersensitivity
analgesics with fewer adverse effects and provides more to any of the drugs used in this study, peptic ulcer disease, or
effective analgesia has been recommended. For this purpose, gastrointestinal bleeding were excluded.
nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids All the cases were verbally informed about the purpose
are commonly used together. and the content of the study before the surgery, and written
Dexketoprofen trometamol is an S-(+)-2-(3-benzoylphenyl) informed consent forms were signed by the subjects who
propionic acidtromethamine salt. Dexketoprofen is an NSAID agreed to participate to the study. Information was given
which has a rapid onset of effect. Dexketoprofen trometamol is about the patient-controlled analgesia (PCA) and visual
more potent and causes less gastrointestinal adverse effects analog scale (VAS) assessment to participants. The patients
compared with ketoprofen [4]. Dexketoprofen trometamol were divided into 2 random study groups by using the sealed
administration was found to be highly effective in treatment of envelope technique.
moderate to severe pain when used as an analgesic in Premedication was not applied to participants for
osteoarthritis, dysmenorrhea, gynecologic, orthopedic, and sedation. The patients were routinely monitored (electrocar-
dental surgery [5–9]. diogram, peripheral oxygen saturation [SpO2], noninvasive
Diclofenac sodium is a phenylacetic acid derivative NSAID blood pressure, end-tidal carbon dioxide [ETCO2]) in the
with the chemical structure of 2-[2-(2,6-dichlorophenyl)
aminophenyl] etanoik acid. Diclofenac sodium is commonly Table 1 Demographic data, duration of anesthesia, and fentanyl
used to treat mild to moderate postoperative and posttraumatic consumption (mean ± SD, n).
pain accompanied by inflammation. Diclofenac sodium admin-
Group DT Group DS
istration was found to be highly effective in the management of
(n = 30) (n = 30)
postoperative pain in various surgical procedures [10–14].
There are a limited number of studies in the literature Age (y) 50 ± 13.4 53 ± 13.9
based on evaluation of analgesic efficacy of dexketoprofen Weight (kg) 75 ± 13.5 74 ± 13.4
Height (cm) 163 ± 7.7 163 ± 7.8
trometamol vs diclofenac sodium [15–17]; however,
ASA I/II (n) 17/13 10/20
according to our research, no study has been found Sex M/F (n) 11/19 6/24
that compares the analgesic efficacy of dexketoprofen Fentanyl consumption (μg) 125.8 ± 31.1 141.6 ± 32.3
trometamol and diclofenac sodium in laparoscopic chole- Duration of anesthesia (min) 70 ± 13.9 75 ± 13.7
cystectomy procedures.

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Dexketoprofen trometamol and diclofenac sodium 129
Group DT Group DS

110

HR (beat/min)
90

70

50
C E 1 2 3 4 5 6 7 8 Ex R 1 2 3 4 5

Intraoperative period Postoperative period

Fig. 1 Peroperative HR values (mean ± SD). C = control, I = induction, E = intubation, Ex = extubation, R = recovery.

operating room. After a 20-gauge intravenous cannula was the postoperative period in the recovery room and at 2, 4, 8,
inserted, 7-mg/(kg h) infusion rate of 0.9% NaCl intravenous 12, and 24 hours in the clinic.
infusion was started. General anesthesia was induced with In both groups, postoperative analgesia was provided with
2-2.5 mg/kg propofol, 1-2 μg/kg fentanyl, and 0.6 mg/kg intraveneous PCA. PCA solutions were prepared with 1 mg/mL
rocuronium. Anesthesia was maintained with 50% O2, 50% morphine dilution and 2 mg of morphine bolus dose, and a
air mixture and maintained with sevoflurane 1%-2%. No 15-minute lockout time was set for all patients. Despite the use of
additional fentanyl or other opiates were administered during PCA morphine, if VAS found was more than 4, intravenous
the intraoperative period. Ventilation settings were adjusted administration of 20 mg of tenoxicam was planned as a rescue
to provide normocapnia. analgesic. For patients with nausea and vomiting, intravenous
Patients in group DT received 50 mg dexketoprofen metoclopramide 10-mg treatment was planned to be administered.
trometamol, whereas patients in group DS received 75 mg During the postoperative period in the recovery room and at
diclofenac sodium, intravenously 30 minutes before the end 2, 4, 8, 12, 18, and 24 hours in the clinic, VAS score of pain,
of surgery. Ramsay Sedation Scale (RSS), and PCA morphine consumption
Heart rate (HR), systolic arterial pressure (SAP), diastolic were recorded. In addition, patient satisfaction, time of first
arterial pressure (DAP), SpO2, and ETCO2 values during analgesic requirement, rescue analgesic requirement, and
intraoperative period before induction (control); during adverse effects (dizziness, headache, nausea, vomiting, drows-
induction; during intubation; and at 5, 10, 15, 30, 45, 60, iness, bleeding diathesis, etc) were recorded.
75, and 90 minutes after intubation and during extubation Statistical analysis was performed by using SPSS 13.0
were recorded. The same parameters were recorded during statistical software package in the application laboratories of

Group DT Group DS

190
170
SAP ( mmHg)

150
130
110
90
70
50
C E 1 2 3 4 5 6 7 8 Ex R 1 2 3 4 5

Intraoperative period Postoperative period

Fig. 2 Perioperative SAP values (mean ± SD).

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130 A. Anıl et al.
Group DT Group DS

110

DAP (mmHg)
90

70

50
C E 1 2 3 4 5 6 7 8 Ext. R 1 2 3 4 5

Intraoperative period Postoperative period

Fig. 3 Peroperative DAP values (mean ± SD).

the UUFM Department of Biostatistics. In this study, Time of first analgesic requirement, rescue analgesic
continuous and discrete variates were expressed in median requirement, and discharge times during postoperative
(minimum-maximum) values, and categorical variables were clinical follow-up periods are presented in Table 2. In the
expressed in frequency and percentage values. Mann-Whit- postoperative period, the first analgesic requirement time
ney U and χ2 tests were used for intergroup comparisons. P was significantly longer in group DT (P b .01). In addition,
b .05 was considered to be statistically significant. the number of patients requiring rescue analgesic was higher
in group DS (P b .01). The duration of hospital stay was
similar in the 2 groups.
3. Results In both groups, during 24 hours postoperatively, adverse
effects like hemorrhagic diathesis and gastrointestinal
The 2 groups were similar with respect to age, sex, weight, height, symptoms or findings due to NSAIDS and severe sedation
ASA class, intraoperative fentanyl consumption, and anesthesia time. and respiratory failure due to opioid were not observed. In
There were no cases excluded from the study (Table 1). group DT, hypotension in 1 case (3%), bradycardia in
There was no statistically significant difference between another case (3%), and nausea and vomiting in 3 cases (10%)
groups in SAP, DAP, and HR values in all assessment points were observed; in group DS, hypotension in 1 case (3%),
during the intraoperative and postoperative period (Figs. 1-3). bradycardia in 2 cases (6%), and nausea and vomiting in 3
There was no significant difference in intraoperative SpO2 cases (10%) were observed. In the perioperative period, no
and ETCO2 values between 2 groups. statistically significant difference was observed according to
As seen in Fig. 4, PCA morphine consumption was the adverse effects between these 2 groups.
significantly less in group DT compared with group DS in all Also, in the postoperative period, no statistically signif-
postoperative follow-up periods (2 and 4 hours: P b .01; 8, icant difference was observed according to VAS, RSS, and
12, 18, and 24 hours: P b .001). patient satisfaction scores between the groups (Tables 3-5).

Fig. 4 Postoperative morphine consumption with intravenous PCA (mean ± SD). R = recovery room.

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Dexketoprofen trometamol and diclofenac sodium 131

Table 2 Time of first analgesic requirement, rescue analgesic Table 4 Ramsay Sedation Scale scores in the postoperative
requirement, and duration of hospital stay (mean [min-max], period (med [min-max]).
n [%]).
RSS (1-6) P
Group DT Group DS value
Group DT (n = 30) Group DS (n = 30)
(n = 30) (n = 30)
Recovery 2 (1-3) 2 (1-3) N .05
Time to first analgesic 60 (15-120) 15 (8-50) ⁎
Clinic
requirement (min)
2h 2 (1-2) 2 (1-3) N .05
Rescue analgesic requirement (n) 5 (16%) 23 (76%) ⁎
4h 2 (1-2) 2 (1-2) N .05
Duration of hospital stay (h) 21 (18-25) 22 (18-26)
8h 2 (1-2) 2 (1-2) N .05
⁎ P b .001 refers to group DT. 12 h 2 (1-2) 2 (1-2) N .05
18 h 2 (1-2) 2 (1-2) N .05
24 h 2 (2-2) 2 (2-2) N .05
Ramsay Sedation Scale: 1 = patient is anxious and agitated or restless, or
4. Discussion both; 2 = patient is cooperative, oriented, and tranquil; 3 = patient
responds to commands only; 4 = patient exhibits brisk response to light
In this first clinical study comparing the analgesic efficacy glabellar tap or loud auditory stimulus; 5 = patient exhibits a sluggish
of intraoperative single-dose intravenous dexketoprofen response to light glabellar tap or loud auditory stimulus; 6 = patient
exhibits no response.
trometamol and diclofenac sodium in postoperative pain
management after laparoscopic cholecystectomy, postoper-
ative morphine consumption and rescue analgesic require-
Dexketoprofen trometamol and diclofenac sodium are
ment were found to be less and time of first analgesic
frequently used NSAIDs for mild to moderate postoperative
requirement was found to be longer in group DT.
pain management as a part of multimodal analgesia.
Postoperative pain VAS scores, sedation scores, patient
Some previous studies in which the analgesic effects of
satisfaction, duration of hospital stay, and frequency of
NSAIDs were compared are summarized in Table 6
adverse effects were similar in both groups statistically.
[14,15,17,21–23].
Laparoscopic cholecystectomy surgery leads to faster
Dexketoprofen trometamol and diclofenac sodium are
healing and less surgical trauma compared with conventional
widely used NSAIDs with active doses (50 mg and 75 mg,
cholecystectomy surgery. According to clinical experience,
respectively) in literature. Our choice is based on reduced
the pain after laparoscopy is less severe and degrades in the
adverse effect incidence assumption for single-dose admin-
short term compared with open surgery [18]. However,
istration of these 2 agents as a part of a multimodal analgesic
postoperative pain management seems to be necessary in the
approach [24].
early period after laparoscopic surgery because of mild to
PCA analgesic consumption and VAS scores are often
moderate pain [19].
used as a method of assessing the efficacy of postoperative
Today, the treatment of acute postoperative pain is still
pain management [25]. However, in clinical studies
not at the desired level, and more than 75% of cases after
evaluating the efficacy of postoperative analgesia, postoper-
surgery complain about moderate or more severe pain [20].
ative opioid consumption and time of first analgesic
Multimodal analgesia, which is a popular postoperative
requirement were found to be more significant than VAS
pain management, is chosen because of the synergistic
scores. In our study, time of first analgesic requirement in the
effects of different pharmacologic agents such as NSAIDs
postoperative period was significantly prolonged in group
and opioids.
DT. We suggest that prolonged time of first analgesic
requirement in group DT was useful for reduction of
morphine consumption.
Table 3 Visual analog scale scores in the postoperative period In addition, the amount of total morphine consumption in
(med [min-max]).
the postoperative period in group DT (18 mg) was significantly
VAS (0-10 cm) P
value
Group DT (n = 30) Group DS (n = 30) Table 5 Patient satisfaction scores in the postoperative period
Recovery 2 (0-5) 2 (0-6) N .05 (med [min-max]).
Clinic Patient satisfaction P
2h 2 (0-4) 2 (0-6) N .05 score (1-4) value
4h 2 (0-4) 2 (0-4) N .05
8h 2 (0-3) 1 (0-4) N .05 Group DT Group DS
12 h 2 (0-6) 1 (0-3) N .05 (n = 30) (n = 30)
18 h 2 (0-6) 1 (0-3) N .05 Postoperative period (24 h) 2 (1-3) 1(1-2) N .05
24 h 0 (0-2) 0 (0-2) N .05 Patient satisfaction score: 1 = very satisfied, 2 = satisfied, 3 = average, 4
Visual analog scale: 0 cm = no pain, 10 cm = very severe pain. = not satisfied.

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132 A. Anıl et al.

Table 6 Some previous studies that compared analgesic effects of NSAIDs.

Studies Procedures Compared agents Result Suggestion
Leman et al Acute lower Oral DT 25 mg vs DS 50 mg No differences in pain scores at DT provides faster and more
[17] extremity the baseline. After 60 min, pain effective analgesia compared
trauma scores in DT declined more rapidly. with DS.
Iohom et al Hip arthroplasty Oral dexketoprofen vs placebo Preop oral dexketoprofen decreased Dexketoprofen treatment was
[14] postoperative PCA morphine the reason for decreased
consumption and post-op IL-6 proinflammatory response.
levels compared with placebo.
Tokgöz et al SWL IM DT 50 mg vs DS 75 mg VAS scores were found to be DT provides more effective
[15] 30 min before procedure significantly lower in group DT analgesia compared with DS.
in the postoperative period.
Durak et al Laparoscopic DS vs paracetamol 15 min Postoperative VAS score at 1 h DS provides more effective
[21] cholecystectomy before procedure was significantly lower in analgesia compared with
group DS. Postoperative paracetamol.
morphine consumption was
found to be similar.
Tuncer et al Abdominal Oral dexketoprofen 25 mg vs Postop opioid consumption and Oral dexketoprofen provides
[22] hysterectomy placebo VAS scores were significantly postop effective analgesia in
decreased in dexketoprofen group. abdominal hysterectomy
procedures.
Ekmekci et al Laparoscopic Tramadol 600 mg (group T) No statistically significant DT 100 mg + tramadol 600
[23] cholecystectomy vs DT 100 mg + tramadol 600 mg difference was found, but opioid mg administration with PCA
(group TD) consumption was lower and technique seems to provide
PCA technique patient satisfaction was higher more effective analgesia.
in group TD.
SWL = shockwave lithotripsy, IM = intramuscular.

lower compared with diclofenac sodium (46 mg). No commonly used parameter in monitoring the level of sedation
significant difference was found between the groups during [29]. Tuncer et al [22] evaluated efficacy of peroperative timing
all follow-up periods regarding VAS scores. In both groups, of oral dexketoprofen administration compared with placebo in
the severity of postoperative pain was found as VAS b 4. patients undergoing abdominal hysterectomy. Despite statisti-
Effective analgesia was provided in the 2 groups with different cally different opioid requirements for both groups, the levels of
doses of opioid consumption and different rescue analgesic sedation in both groups were found to be similar. In our study,
requirements. the degree of sedation that was assessed with RSS was also
The incidence of adverse effects is the most important found to be similar between groups.
factor for limiting the use of a drug. NSAIDs affect many Tuncer et al [30] found that combined use of NSAIDs and
systems, and the possible adverse-effect profile includes a opioids postoperatively decreased total opioid consumption
wide spectrum ranging from dyspepsia to death. In a and the opioid-related adverse effects in patients undergoing
meta-analysis of studies using dexketoprofen in acute and gynecologic malignancy surgery. In our study, although
chronic pain, no serious deksketoprofen-related adverse morphine consumption was higher in group DS, there was no
effects such as gastrointestinal bleeding, myocardial infarc- statistically significant difference between the 2 groups in
tion, or death had been reported [26]. Dyspeptic complaints nausea and vomiting. Emetic effects of anesthetic agents
were found to be the most common dexketoprofen-related should be considered before making a clear statement on
adverse effects in clinical practice. These complaints were nausea and vomiting frequency, and more studies should be
observed in long-term treatment protocols and in multiple conducted on large sample groups. We suggest that the
doses of the drug administration. Diclofenac sodium–related reduced morphine consumption in group DT compared with
dyspeptic complaints have been the majority of the reported group DS will decrease the incidence of adverse effects
adverse effects in recent studies [27]. In our study, no associated with opioid use in clinical practice.
statistically significant difference in terms of adverse effects Thaweekul et al [31] studied the effect of postoperative
was found. We suggest that the reason was related to the use single-dose intramuscular diclofenac sodium administration
of a single dose of diclofenac sodium and dexketoprofen on PCA morphine consumption compared with placebo in
trometamol. patients undergoing explorative laparotomy for gynecologic
Depending on the amount of opioid used in PCA, adverse surgery. Although morphine consumption was higher in the
effects such as urinary retention, sedation, respiratory depres- placebo group, postoperative VAS scores and patient
sion, nausea, and vomiting may occur [28]. RSS is the most satisfaction were found to be similar.

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Dexketoprofen trometamol and diclofenac sodium 133

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