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Comparison of IV Dexketoprofen Trometamol, Fentanyl, and Paracetamol
Comparison of IV Dexketoprofen Trometamol, Fentanyl, and Paracetamol
Comparison of IV Dexketoprofen Trometamol, Fentanyl, and Paracetamol
PII: S0735-6757(17)30743-X
DOI: doi: 10.1016/j.ajem.2017.09.019
Reference: YAJEM 56964
To appear in:
Received date: 3 August 2017
Revised date: 9 September 2017
Accepted date: 13 September 2017
Please cite this article as: Behcet Al, Mehmet Mustafa Sunar, Suat Zengin, Mustafa Sabak,
Mustafa Bogan, Basri Can, Seval Kul, M. Murat Oktay, Sevki Hakan Eren , Comparison
of intravenous dexketoprofen trometamol, fentanyl, and paracetamol in the treatment of
patients admitted to the emergency department for renal colic: A randomized controlled
trial, (2017), doi: 10.1016/j.ajem.2017.09.019
This is a PDF file of an unedited manuscript that has been accepted for publication. As
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Prof. Dr. MD. Behcet Al behcetal@gmail.com, Emergency department of Medicine
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MD. Phy. Mehmet Mustafa Sunar, sunarmehmet@hotmail.com (Emergency department of
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Medicine Faculty, Gaziantep University/Turkey)
This study has been awarded with the best oral presentation third prize in 13th National
Emergency Medicine, 4th International Emergency Medicine and 4th International Critical
Care and Emergency Medicine congresses held by the Emergency Physician Association of
Turkey (EPAT) ĠN Antalya 18-21 May 2017/TURKEY
Conflicts of interest: All authors attest that they don’t have any potential conflicts of interest
for current study.
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Word count: 3490
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Registration number: Unfortunately, we couldn’t have registration number just before starting
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to study.
Author contributions: Al B and Sunar MM conceived the study, designed the trial, and
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undertook recruitment of participating centers and patients and managed the data, including
quality control. Zengin S and Sabak M, and Bogan M supervised the conduct of the trial and
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data collection. Kul S provided statistical advice on study design and analyzed the data. Can
B, and Oktay MM drafted the manuscript. Eren HS chaired the data oversight committee. Al
B and takes responsibility for the paper as a whole; and all authors contributed substantially to
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its revision.
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Abstract
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Materials and Method: Data obtained from the emergency departments of Gaziantep
University's Hospital for Research and Practice along with two other state hospitals in
Gaziantep, Turkey between January 2016 and January 2017 was used for this study. A total of
three hundred patients (n=300), who presented to the ER with complaints most common to
renal colic whose diagnoses were subsequently confirmed with Computerized Tomography
were included in the study. Patients' pain scores were recorded using the Visual Analogue
Scale, at admission (immediately before drug administration), then at the 15th, and 30th
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minutes. SPSS 22.0 software package was used for analysis. P<0.05 was considered
significant.
Results: At the 15th minute comparison,, the efficacies of the three groups of drugs were not
superior to one other, but at the 30th minute, dexketoprofen trometamol was statistically more
effective than paracetamol and fentanyl. There was no statistically significant difference
between fentanyl and paracetamol. The need for additional analgesia in the group receiving
dexketoprofen trometamol was found to be lower. Dexketoprofen trometamol was statistically
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superior to the other two agents in achieving full analgesia at the end of the thirty-minute
period. Fentanyl was found to be statistically significant in achieving moderate analgesia.
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Conclusion: As a Non-steroidal antiinflammatory drug dexketoprofen trometamol is superior
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to paracetamol and fentanyl in achieving analgesia and reducing the need for additional drugs
for the treatment of renal colic.
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KeyWords: Analgesic, Dexketoprofen Trometamol, Fentanyl, Paracetamol, Renal Colic,
Visual Analogue Scale, Efficacy, Emergency Department.
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Introduction
Abdominal pain lasting less than 12 hours, back pain or costovertebral angle tenderness
(CVAT) , and the presence of hematuria are the most important clinical symptoms (2). Renal,
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accompanied by high patient satisfaction. The most common approach is the conservative
approach which includes the introduction of fluids and pain relief therapy (9). Non-steroidal
anti-inflammatory drugs (NSAID) are the more preferred agents for pain relief because they
are non-addictive and for having fewer side effects unlike other agents with side effects such
as constipation, respiratory depression, and mental changes (10,11).
Other than that, opioids –notably morphine sulfate (12), paracetamol (13), calcium channel
blockers, alpha antagonists, and local heat application (9,14) are used in the treatment of RC.
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Most comparative studies have been done with NSAIDs, paracetamol and morphine sulfate
(15,16). The most important advantage of Fentanyl is that it provides a very high level of
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analgesia and that its effect starts rapidly and ends early. Although there are studies on its
efficacy in the treatment of RC in the literature, there aren't a sufficient number of randomized
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clinical trials comparing its effect with other agents.
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In this study, the efficacies of intravenous DKT, fentanyl, and paracetamol in patients
presenting with an RCcomplain to the emergency department were compared with a
randomized controlled trial. The study is particularly important in terms determining the role
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of fentanyl, which has a very high efficacy in pain-killing, in the treatment of RC, and the
potential this has for contributing to the literature.
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Ethics committee approval (Decision no. 2015/342) was obtained from the Gaziantep
University Faculty of Medicine on 14.12.2015 for this study, which was planned as a
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randomized double blind study. It was carried out in accordance with the Declaration of
Helsinki protocols. A total of three hundred (n=300) patients who presented to the emergency
departments of Gaziantep University's Hospital for Research and Practice along with two
other state hospitals in Gaziantep, Turkey (Dr. Ersin Arslan State Hospital and ġehit Kamil
State Hospital) with complaints of clinically manifest RC and whose diagnoses were
confirmed with CT were included in the study.
Inclusion Criteria:
Exclusion criteria:
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1. Patients aged below 16 years and over 65 years,
2. Those with a side pain complaint lasting longer than 12 hours,
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3. Those with a history of direct blunt trauma to the CVAT within the last week,
4. Patients who marked the VAS at <40 mm or <4 cm at the zeroth minute in the
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emergency department,
5. Patients with a history of allergy to the drugs to be used in the study,
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6. Patients with a systolic arterial blood pressure of <90 mmHg at the time of admission
to the emergency department,
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7. Patients with a history of prostate, renal and adrenal, and bladder malignancy or a
history of surgery on these regions within the last six months,
8. Patients with any history of chronic pain syndrome,
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(PID),
12. Patients not diagnosed with RC as a result of imaging and laboratory tests. Patients
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who had been treated with renal colic suspicion at the time of admission but
who's diagnosis was not confirmed by CT as renal colic were excluded from the
study
All patients were evaluated with detailed physical examination and detailed
history. Complete blood count (CBC), complete urinalysis, C-reactive protein (CRP),
International Normalized Ratio (INR), urea, and creatinine lab tests were requested for all
patients as well. All patients were monitored during drug administration.
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Drug selection:
The drugs in the groups were numbered from one to one hundred. They were
appointed to one of the study groups according to the study number. This procedure was
prepared by someone outside the emergency department in the form of random octal blocks
with the help of a computer. Only this person knew which drugs the numbers signified. The
numbers pertaining to the study groups were placed in opaque envelopes that did not show
through. Drug preparation and administration were organized by two designated nurses in the
emergency department. The first nurse took the trial medication out of the envelopes and
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made them ready for use. The second nurse was responsible for blindly administering the trial
medication.
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The drugs and the routes of administration:
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Three study groups were formed for intravenous (IV) DKT, fentanyl, and paracetamol. 50
mgr of DKT (Arveles ampuoule® , 50 mg/ml dexketoprofen trometamol, Menarini
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International, Italy) in the form of an IV rapid infusion in 100 ml of isotonic saline, 2
micrograms/kg of fentanyl (Talinat ampoule®, 0.5 mg/10 ml fentanyl citrate, VEM Ġlaç,
Turkey), and 10 mg of paracetamol (Parol vial®, 10 mg/ml, 100 ml vial paracetamol, Atabey
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Kimya San, Turkey) were administered to the groups given drugs. The paracetamol was
drawn from the vial and injected into a 100 cc physiological saline solution by the first nurse.
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All three drugs were adjusted run out within five minutes in a 100 cc physiological saline
solution.
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Before the trial drug was administered, the basal pain values of the patients were
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assessed with the Visual Analogue Scale (VAS) consisting of values between 0 and 10 at the
0th, (immediately before drug administration), 15th, and 30th minutes. It was established that
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the patient did not see the previous VAS when marking the VAS. Three identical VAS rulers
were used for this. At the thirtieth minute, the patients were asked whether they needed
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additional analgesics. Rescue medication was administered to those who needed them. The
same dose of the drug used in the study and one of the other two drugs used in the study, in
addition to diclofenac sodium or tramadol HCL were used as rescue medication. Here, the
choice was left up to the physician. Treatment related drug side effects (such as nausea,
vomiting, hypotension, arrhythmia, dizziness, and confusion) that developed in the patients
were recorded in the study form.
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killers from other centers, one patient being diagnosed with pregnancy in addition to
urolithiasis, two patients who were found to have acute appendicitis in addition to urolithiasis,
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six patients leaving the emergency ward without waiting for the thirtieth minute upon early
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relief of their symptoms, and five patients refusing to undergo CT.
Statistics
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In the analysis of the data, relationships between categorical variables were tested by
using the Chi square test and correlations between sequential variables were tested with the
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Spearman Rank correlation coefficient. The SPSS 22.0 software package was used for
analysis. P<0.05 was considered significant.
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RESULTS
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A total of 300 RC patients, 100 from each group, were included in the study. Of these,
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216 were male (72%) and 84 were female (28%). The majority of cases were between the
ages of 25-39 (49.7%) (p=0.001), and the average age was 42.2 years. There was no
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significant relationship between sex and the agents used (p=0,215). Nausea and vomiting
accompanied pain in 47.3% (n=142) of the patients at the time of admission. CVAT was
found positive in 256 (85.3%) patients. Patients receiving fentanyl developed more
complications (p=0.008) (Table 1).
The majority of patients (n=156) marked the VAS between 9-10 at first admission (p=0.001)
(Table 2). All three drugs significantly reduced the VAS score which was between 9-10 at the
fifteenth minute (p=0.001). Although, numerically, DKT (n=45) seemed to be more effective
than Paracetamol (n=40) and Fentanyl (n=36) inlowering the VAS score, this superiority
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was not statistically significant (p=0.672). When the reduction of VAS values at the thirtieth
minute was evaluated, DKT was found to be more effective (p=004) (Table 3, Figure 1)).
57% of the patients (n=171) needed rescue medication (p=0.006). The DKT group (31%) was
the one that least needed rescue medication, while the paracetamol group (53%) was the one
that needed it the most. DKT (n=45) was the rescue medication used most often (p=001).
Apart from the drugs in the study groups, diclofenac sodium was the most commonly used
rescue medication (Table 3).
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During discharge, the patients were verbally asked whether their pain was "mildly,
moderately, or completely gone". While, according to the verbal statements of the patients,
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Fentanyl (p=0.001) was statistically more effective in moderately reducing pain, DKT was
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found to be more effective in completely stopping the pain (p=0.001) (Table 3).
Systolic blood pressure was <140 mmHg in 283 (94%) of the patients at first admission,
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independent of basal blood pressure. There was no correlation between the VAS level and the
level of systolic blood pressure (p=0.545). At the time of admission, the pain was in the right
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costovertebral region in 54.7% (n=164) of the patients, and on the left side in the rest (n=136).
There was no significant relationship between pain localization and the VAS score at first
admission (p=0.200).
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DISCUSSION
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In the United States, more than 1 million patients visit the emergency clinics due to
RC (17). In Europe, acute RC is the cause of 7-9% of emergency ambulatory service calls
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made due to pain (18). Its prevalence rate in the whole world varies between 12% and 15%
(19). There are not enough records or information in our country in this regard (1). A person's
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risk of having an RC attack throughout their entire life is between 1-10% (20).
In a study by Brown et al., in which more than one million patients were evaluated, it was
reported that patients who presented to emergency departments with RC were usually in the
middle age group and of the male sex (21). The fact that there is a male patient and middle
age predominance in RC is confirmed by the results of our study and other studies (23-25).
However, the ratio of male patients in our study was much higher compared to the literature.
Ayan et al. (26) have stated that IM diclofenac sodium is statistically more effective
than IV paracetamol in the pain treatment of RC. Pathon et al. ( 27 ) compared the efficacy of
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IM diclofenac sodium, IV paracetamol, and IV morphine in reducing pain at the end of the 30th
minute in 1070 RC patients. According to this it was found that IM diclofenac sodium was superior
to the other two agents in reducing pain by more than 50%, and that there was no statistical
difference between IV morphineand IV paracetamol in a randomized controlled trial they
conducted, Azizkhani et al. (28) found that IV morphine reduced RC pain more than IV paracetamol,
but caused more side effects. There are other studies which emphasize that NSAIDs are superior
to paracetamol and opioids in reducing RC pain (15.29). In contrast to these studies, Masoumi et
al. (30) have stated that IV paracetamol is more effective in reducing pain severity than IV morphine
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in their randomized controlled double blind study. Confirming this, Sin et al. (31) have stated that IV
paracetamol is superior to both IV morphine and IM diclofenac sodium in providing analgesia in
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RC. BektaĢ et al. (12) emphasize that the analgesic efficacies of IV paracetamol and IV morphine in
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RC are similar, but that both agents are superior to placebo. Serinken et al. (32) found that the pain-
killing effects of IV paracetamol and IV morphine were similar in a randomized double-blind study
they conducted on 73 patients with RC. Similar to the aforementioned last two studies, Ay et al. (33)
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compared IV DKT and IV meperidine in 52 RC patients in a randomized, double-blind study. At the
30th minute, the numerical grading scale and renal colic symptom scale were found to be similar in
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both groups.
There are numerous studies in the literature concerning the comparison of NSAIDs,
paracetamol, and opioids (especially morphine) in RC patients, as can be seen from the
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examples given above. However, no study was found comparing fentanyl, which provides
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much more analgesic effect than morphine, with NSAIDs. There are studies in which different
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forms of fentanyl are compared with each other or with morphine. Deaton et al. (34) divided
40 patients who presented to the emergency department with abdominal pain into two groups,
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and compared the efficacy of IV morphine (0.1 mg/kg) and nebulized fentanyl (2 μg/kg)
according to the VAS scores at the 10th, 20th, 30th, and 40th minutes. They indicated that
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nebulized fentanyl provided more significant analgesia at all time intervals. Imamoğlu et al.
(35) compared the VAS values of nebulized and IV fentanyl at the 30th minute by dividing
115 patients who presented to emergency service with the complaint of RC into two groups.
While, based on this, there was no statistically significant difference in pain values, it was
found that the IV form provided a faster analgesic effect, required fewer rescue medications,
and, while not statistically significant, caused more side effects compared to the nebulized
form. There are also studies comparing DKT, morphine, and paracetamol outside the context
of RC. It has been stated that DKT provides a better analgesic effect than paracetamol (36) for
operative hysteroscopy, that morphine provides a better analgesic effect than paracetamol for
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sciatic pain (37), and that paracetamol, DKT, and morphine are not superior to one another for
back pain (38). In our study, the relative difference between the efficacies of the three drugs at
the fifteenth minute according to the VAS was not statistically significant. In particular, the
numerical efficacy of fentanyl on the high VAS scores (VAS 9-10) at the fifteenth minute was
not statistically significant. DKT was found to be statistically more effective compared to
paracetamol and fentanyl at the thirtieth minute, while fentanyl and paracetamol were not
statistically superior to one another.
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The effectiveness of a drug given to patients with RC is also measured by whether or
not additional drugs need to be administered. Fentanyl has not been extensively studied in the
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literature with regard to this. Çevik et al. (39) compared DKT, tenoxicam, and lornoxicam in
terms of the need for additional drugs. They stated that at the end of the thirtieth minute, the
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group that received DKT needed less additional drugs. In two other RC studies comparing IV
paracetamol and IV morphine with regard to the need for additional drugs , the group receiving
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morphine needed more additional drugs (12,32). In a meta-analysis (15), it is emphasized that
NSAIDs require less additional pain relief medications compared to opioid drugs. In our
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study, the group receiving DKT statistically needed less additional drugs compared to the
other two groups when they were compared according to the need for additional analgesics at
the end of the thirtieth minute. No superiority has been found between fentanyl and
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In a meta-analysis study (15) by Holdgate et al. comparing NSAIDs and opioids for
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RC, it is reported that patients receiving opioids had more side effects, mostly in the form of
vomiting, and this is considered statistically significant. Grissa et al. (40) emphasize that IV
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paracetamol and IM piroxicam are not different in terms of side effects in patients with RC.
Serinken et al. (32) report that IV morphine causes more side effects than IV paracetamol,
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mostly in the form of dizziness. BektaĢ et al. (12) have found that morphine causes more nausea
and vomiting than paracetamol in patients with RC. As can be seen from the present literature
reviews, the side effects of opioid agents are greater than those of NSAIDs. The results of this
study also support this. However, due to the overcrowding of the emergency ward and busy
work schedule, patients could not be followed for a long period of time. Complications that
may have developed during the later course of these patients could not be recorded. One
reason for the higher incidence of side effects (nausea-vomiting, headache, dizziness, severe
hypotension) in the fentanyl group could be the rapid administration of fentanyl in order to
observe the drug administration durations specified in the study.
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In this study, we asked patients to verbally assess their pain at discharge after the treatment
had ended, compared to their state at first admission. Based on this, DKT was statistically
more effective in the group that declared that the pain was "completely gone", while there was
no statistical difference between fentanyl and paracetamol. Fentanyl's pain-relieving effect
was found to be statistically significant in the group that expressed their pain to have
"moderately decreased", while similar results were obtained for DKT and paracetamol.
The fact that the half-lives and onset times of the drugs used in the study were not taken into
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consideration, the possibility that side effects may be different when each drug is
administered within the same duration of time, and that the patients could not be followed for
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long-term side effects are important limitations. The use of a medication that is not widely
available; the lack of comparison to a more commonly used NSAID to treat renal colic,
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and the short patient follow-up duration can be also considered as limitation points.
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In conclusion, this study has shown that IV NSAIDs (DKT) are superior to both paracetamol
and fentanyl in terms of both analgesia and side effects in RC patients. Although fentanyl is
known to be a very powerful pain killer, it is not as effective as NSAIDs in RC. However, it
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can be given together with NSAIDs for achieving rapid, early analgesia. NSAIDs should be
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the first choice for the treatment of RC in emergency departments. If they are not found,
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paracetamol or opioids should be tried. or opioids should be tried. Patients should be followed
for a longer period in terms of complications after the use of fentanyl.
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Table1: Comparison of drugs used and sex, age, and complications developed.
Drug Used
DKT Paracetamol Fentanyl Total
n(%) n(%) n(%) n(%)
Sex
Female 22 (22.0) 33 (33.0) 29 (29.0) 84 (28.0)
Male 78 (78.0) 67 (67.0) 71 (71.0) 216 (72.0)
Age Groups
16-24 13 (13.0) 15 (15.0) 25 (25.0) 53 (17.7)
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25-39 58 (58.0) 48 (48.0) 43 (43.0) 149 (49.7)
40-54 25 (25.0) 20 (20.0) 28 (28.0) 73 (24.3)
55-64 1 (1.0) 17 (17.0) 2 (2.0) 20 (6.7)
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>65 3 (3.0) 0 (0.0) 2 (2.0) 5 (1.7)
Drug
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complication
Hypotension - - 3 (3.0) 3 (1.0)
Dizziness 1 (1.0) 1 (1.0) 9 (9.0) 11 (3.7)
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Headache - - 1 (1.0) 1 (0.3)
Vomiting 1 (1.0) 1 (1.0) 1 (1.0) 3 (1.0)
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Table 2:Comparison of Drug Efficacy and VAS Values at the 0th 15th and 30th Minutes
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VAS <5 5-6 7-8 9-10 <5 5-6 7-8 9-10 <5 5-6 7-8 9-10
Prior to 10 31 59 2 65 33 8 28 64
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treatment 0 (50.0) (25.0) (37.8) 0 (10.0) (52.4) (21.2) 0 (40.0) (22.6) (41.0)
15th 45 32 18 5 40 34 23 3 36 40 22 2
Minute (45.0) (32.0) (18.0) (5.00) (40.0) (34.0) (23.0) (3.0) (36.0) (40.0) (22.0) (2.0)
30th 85 11 2 2 70 10 19 1 73 10 14 3
Minute (85.0) (11.0) (2.0) (2.00) (70.0) (10.0) (19.0) (1.0) (73.0) (10.0) (14.0) (3.0)
ACCEPTED MANUSCRIPT
Table 3: Comparison of Rescue Medications and Drugs Used and the state of pain at
discharge
Drug Used
DKT Paracetamol Fentanyl Total
n(%) n(%) n(%) n(%)
Rescue Medication
PT
DKT 1 (1.0) 13 (13.0) 31 (31.0) 45 (15.0)
Paracetamol 11 (11.0) 0 (0.0) 2 (2.0) 13 (4.3)
RI
Fentanyl 12 (12.0) 8 (8.0) 0 (0.0) 20 (6.7)
SC
Tramadol 3 (3.0) 16 (16.0) 4 (4.0) 23 (7.7)
Diclofenac sodium 4 (4.0) 31 16 (16.0) 53 8 (8.0) 28 (9.3)
NU
Total (31,0) (53.0) 45 (45.0) 129 (43.0)
Pain at discharge
Slightly Reduced 5 (5.0) 17 (17.0) 3 (3.0) 25 (8.3)
MA
Figure 1: Comparison of Drug Efficacy and VAS Values at the 15th and 30th Minutes
PT
RI
SC
NU
MA
E D
PT
CE
AC