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Original Contribution
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.
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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
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
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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
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.
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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