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Profile Mustafa Serinken ,M.D.
Department of Emergency Medicine, Pamukkale University School
of Medicine, Denizli, Turkey
Publication &Presentations
Topical Ketoprofen Versus Placebo in Children Presenting With Ankle Sprain to
the Emergency Department: A Randomized Controlled Study (2018)
Intravenous paracetamol vs ibuprofen in renal colic: a randomised, double-
blind, controlled clinical trial (2017)
Rudimentary horn pregnancy mimicking an acute abdomen in the emergency
department (2015)
Profile Cenker Eken,M.D.
Department of Emergency Medicine, Akdeniz University School of
Medicine, Antalya, Turkey
Publication &Presentations
Intravenous paracetamol versus dexketoprofen versus morphine in acute
mechanical low back pain in the emergency department: a randomised double-
blind controlled trial (2014)
Intravenous paracetamol versus morphine for renal colic in the emergency
department: a randomised double-blind controlled trial (2012)
Profile Özgür Karcıo lu,M.D.
Clinic of Emergency Medicine, İstanbul Training and Research
Hospital, İstanbul, Turkey
Publication &Presentations
A systematic review of safety and adverse effects in the practice of therapeutic
hypothermia (2018)
Pain treatment in patients with acute pancreatitis: A randomized controlled
trial(2016)
Outline
Abstract Participants Methods

Statistical analysis Results Discussion

Conclusion
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Abstract
Abstract

Dysmenorrhea is one of To compare the effects


the most common acute of IV paracetamol with
Background pain disorders among dexketoprofen in Aims
women of reproductive patients presenting with
age. primary dysmenorrhea to
the emergency
department.
Abstract
Patients over 18 years old presenting with
pelvic pain related to menstruation were
eligible for the study.
Study Design patients received 1 g paracetamol or
50 mg dexketoprofen in 100 mL normal saline Method
with a 4-5 minute infusion via the intravenous
route.
Pain intensity was measured by a visual
analog scale at 15 and 30 minutes
Randomized controlled trial
Pain improvement in the dexketoprofen group
was better than in the paracetamol group at
Abstract
15 (median difference: 8, 95% CI: 0 to 16, p=0.048)
and
30 (median difference: 6, 95% CI: 1 to 12, p=0.028)
minutes, which was statistically significant but not
clinically significant.
Results Conclusion

Dexketotoprofen has a better visual analogue


scale score that is not clinically relevant
compared to paracetamol.
Participants
Participants
Inclusion criteria Exclusion criteria
Patient under 18 years old
Patients over 18 years old Patients with signs of peritoneal
presenting with pelvic pain related irritation
to menstruation allergy to the study drugs
A normal physical examination history of renal and liver failure
without a remarkable pathology alcohol or drug abuse
was also accepted as an eligible received painkillers within the last six
diagnosis. hours
refused to give informed consent
METHODS
Methods
Study setting and design
Prospective randomized
Double-blind
Controlled study from tertiary care hospital
(December 15, 2014 - April 15, 2015)
The central ethics committee (2014/70177)
The clinicaltrial.gov ID is NCT02373514
Superiority trial with two intervention arms
(IV dexketoprofen, and paracetamol)
Interventions
Pain intensity was
measured by a visual
analog scale at 15 and 30
1 gr paracetamol 50 mg dexketoprofen
(Perfalgan, Bristol Myers, minutes
(Arveles, UFSA,
Italy) In 100 mL normal Turkey) In 100 mL
saline with a 4-5 minute normal saline with a
4-5 minute infusion
infusion via the IV route via the IV route
Interventions
Drugs were identical in color
One of the study arms was established in a 1:1
Ratio according to eight computerized randomization blocks
Designated numbers kept in an opaque envelope
Nurse, Physician and Patients are all blinded to drug
Physician, the nurse administered the drug, and the patients were
all blinded
Methods of measurement
100 mm visual analog scale displaying the numbers
Carried out at baseline, 15, and 30 minutes after administration
Blinded to previous VAS scores
The need for rescue drug and adverse events
(recorded on the study form)
Drug-related side effects attributed to either of the drugs were
evaluated in detail (Nausea was not accepted)
Outcome measures

Primary : Pain relief at Secondary : Need


15 and 30 minutes for rescue drug and
after administration adverse effects
drug
Statistical analysis
Statistical analysis
Study data were
MedCalc
Statistical Package for Social Sciences 18.0 (SPSS Inc.; Chicago,
IL, USA)
Confidence Interval Analysis software
Numerical data were
Mean ± standard deviation
Median interquartile range (IQR)
Frequency data as rates
Statistical analysis
Study data
95% confidence interval (95% CI).

Normality analysis
Kolmogorov Smirnov test
Two-group comparisons for numerical data
Mann-Whitney U test and chi-square test for frequency data

Power analysis
Sample of 37 patients in each group
95% power and a standard deviation of 19 mm
Statistical analysis
All hypotheses
Two-tailed
Alpha-critical value of 0.05 was accepted as significant

All analyses were


Intention-to-treat principle
Result
to who assess
inclusion criteria

Result
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Result
Result
Result
Discussion
Discussion

Either IV dexketoprofen or IV paracetamol provided pain relief in


primary dysmenorrhea. Despite better VAS score with
dexketoprofen over paracetamol at 15 and 30 mins

Dysmenorrhea is attributed to high levels of prostaglandins. NSAIDs


act by decreasing synthesis of prostaglandins by blocking the
cyclooxygenase (COX) enzyme
Discussion
Dexketoprofen is an NSAIDswith short half life and rapid onset of
action

Paracetamol provide its analgesic effect , specifically by inhibiting


COX-3

The advantage of paracetamol is that is does not cause GI bleeding


or dyspepsia
Discussion
A Cochrane meta-analysis reported that NSAIDs achieve pain relief
albeit GI side effect are still a concern

However paracetamol remains the preferred choice for


dysmenorrhea among young women around the world and its
primary site of action may still be selective with variable inhibition if
PG production so IV paracetamol is both safe and effective drug
Discussion
Most studies are interested in post operative pain , IV paracetamol has
been found to be as effective as opioids and Paracetamol is differ from
both IV opioid and NSAIDs about side effect (eg. GI symptoms, respiratory
depression

A retrospective analysis of patient with dysmenorrhea by ayan et al.


Reported that IV paracetamol had better pain relief than intramuscular
diclofenac sodium at 30 mins
Conclusion
Conclusion

IV dexketoprofen has better VAS scores that are not


clinically significant in both groups
Thank you

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