Diclofenac is effective for pain management in a variety of conditions: 1) Diclofenac was shown to be as effective as sumatriptan for treating migraine headaches and had advantages in onset of pain relief and reduction of symptoms. 2) Studies found diclofenac reduced fever and throat pain in patients with sore throats and was beneficial as an adjuvant therapy for painful ear, nose, and throat infections. 3) Diclofenac provided wide benefits in reducing inflammation and rapidly relieving symptoms in conditions like acute pharyngitis, tonsillitis, and otitis externa.

1. Role of NSAIDs
in Pain Management
CP-VOL-0322

2. Session Agenda
▹ Pain, types and division of pain
▹ Strategies for pain control
▹ Pain assessment
▹ Pain management - with NSAIDs
▹ Revisit Diclofenac
▹ Updates & newer Clinical trials

3. ”
“It defines pain as “An
unpleasant sensory and
emotional experience arising
from actual or potential tissue
damage or described in terms of
such damage”.
The International Association for the Study of Pain
http://pain-management-info.com/definition-of-pain/

4. ”
“An unpleasant sensation and
emotional response to that
sensation”.
The American Academy of Pain Medicine
http://pain-management-info.com/definition-of-pain/

5. ”
The definition of pain that is most appropriate for
use in clinical practice
“whatever the experiencing person says it is,
existing whenever he says it does.”
Was given by Margo McCaffrey in 1968
http://pain-management-info.com/definition-of-pain/

6. ▹ Acute pain: duration < 3 months, acts as a warning defensive (post-
operative pain, traumatic, associated with medical procedures).
▹ Chronic pain: duration > 3 months, does not fulfill the role of
warning and defensive, due to the nature and symptoms of the
disease is considered in itself, and requires a multitherapeutic
activities.
▹ Survived pain: most often occurs as a result of improper treatment
of acute pain, persists despite the healed tissue, the damage to
which resulted in acute pain.
Types of pain – based on duration
Ann Agric Environ Med. 2013; Special Issue 1

7. ▹ Anatomic pain – may be physiological receptor-functional (protective) or pathological, as
a result of local changes.
▹ Physiological pain – superficial pain, caused by irritation of the skin receptors, mucous
membranes and cornea by a damaging factor.
▹ Pathological pain – caused by chronic irritation of pain receptors by pain mediators
released from damaged tissues.
▹ Deep pain – is pathological, can be caused by blood vessels, bone and joint system,
muscles or organ structure.
▹ Vascular pain – caused by stimulation of mechano- and chemo- pain receptors, located in
the outer membrane of large arteries and veins. Stretching of the vascular vessels causes
pulsating, tension headaches.
▹ Bone and joint pain – the source of pain is stimulation of the pain receptors of the joint
capsule and periosteum.
▹ Myalgia – caused by irritation of the receptors in muscles and fascias by accumulated
metabolites, when they are over-load and tired.
Division of pain
Ann Agric Environ Med. 2013; Special Issue 1

8. ▹Organ pain – include biliary and renal colic.
▹Wired pain – arises as a result of direct stimulation of the nerve fibers or pathways. Includes
neuralgia, causalgia,radicalgia and phantom pain.
▹Neuralgia – applies to the trigeminal nerve, sciatic, femoral and lateral femoral cutaneous nerve.
▹Radicalgia – exacerbated by coughing and radiating movements to the appropriate areas of
the skin.
▹Causalgia – neuralgia with an autonomic component, results from large nerve injuries, with
many of the sympathetic nerves. Pains are burning with dystrophicchanges – cyanosis, oedema,
muscle atrophy
▹Convolutional pain – the result of compression on the nerve plexus, caused by cancer or
inflammatory changes in the neck, top of the lungs, lower pelvis.
▹Phantom pain – occurs in patients after amputation and relates to pain in the amputated limb.
Incidence of this pain explains the existence of chronic pain of embedded memory.
Division of pain
Ann Agric Environ Med. 2013; Special Issue 1

9. Pain – social cause
Social consequences of pain:
▹ –– severe and chronic pain hinder normal functioning and
implementing daily duties;
▹ –– they lead to the elimination of signs of social activity
▹ – patient focus thoughts on the pain and the constant
searching for the cause;
▹ –– can cause mental isolation and depression – patient has a
sense of dramatically reduced availability of the
surrounding world.
▹ ––may cause conflicts with family or friends – patient may fall
into a depressive mood manifested by sadness, irritability
and outbursts of anger
Apart from physical and psychological consequences,
pain also has social consequences
Ann Agric Environ Med. 2013; Special Issue 1

10. ▹ Pharmacotherapy. Should be individualized. The choice of drug
should be based on appropriate diagnosis and currently used
analgesic treatment.
▹ Physical therapy and rehabilitation – a supporting method - The
most popular methods of physical treatment are: thermotherapy
(heat), cryotherapy(cold), laser therapy, electrotherapy, manual
technics,medicinal extracts, kinesi therapy.
Strategies of pain control
Ann Agric Environ Med. 2013; Special Issue 1

11. Strategies of pain control
▹ Neuromodulation – neuromodulating treatments are aimed at stimulating the pain systems.
Currently, several neuromodulation methods are used: percutaneous nerve
electrostimulation (TENS), peripheral nerve stimulation, acupuncture and vibration.
▹ Psychological therapies – psychological factors have a big influence on the perception of
pain, as well as the effectiveness of the treatment. Therefore, all patients with chronic pain
should be able to take advantage of professional psychological help, which can affect the
emotional aspect of pain.
▹ Invasive methods – invasive methods of pain management should be implemented and
enforced by experienced
▹ Specialists in specific cases. There are many methods: from individual nerves blocks, by
intrathecal administration of drugs (e.g. epidural anesthesia during childbirth) to neuro
destractive methods (thermolesion, neurolysis) and neurosurgery.
Ann Agric Environ Med. 2013; Special Issue 1

12. Pain
Assessment

13. Assessment tool 1
Number
rating scale
(Over age 9)
Option to verbally rate your pain from 0 to 10 or
to place a mark on a line indicating your level of
pain. Zero indicates the absence of pain, while 10
represents the most intense pain possible.
Front Psychol. 2016;7:1466. doi:10.3389/fpsyg.2016.01466

14. Assessment tool 2
Wong-Baker
Faces Pain
Scale
(Over age 13)
Scale combines pictures and
numbers for pain ratings
Acad Emerg Med. 2010;17(1):50-4. doi:10.1111/j.1553-2712.2009.00620.x

15. Assessment tool 3
FLACC
Scale
FLACC stands for face, legs, activity, crying, and consolability.
The FLACC pain scale was developed to help medical observers assess the level of pain in
children who are too young to cooperate verbally. It can also be used in adults who are unable to
communicate.
Front Psychol. 2016;7:1466. doi:10.3389/fpsyg.2016.01466

16. Trauma
Sprains
Strains

17. • Musculoskeletal conditions are a diverse group with
regards to pathophysiology but are linked
anatomically and by their association with pain and
impaired physical function.
• Pain is the most prominent symptom and
determinant of disability.
Pain and Disability Associated with Musculoskeletal Diseases
Global burden of osteoarthritis in the year 2000, Deborah Symmons, Colin Mathers, Bruce Pfleger

18. Pain and Disability Associated with Musculoskeletal Diseases
• A major impact on society due to their frequency,
chronicity, and disability.
• Work disability
• A major cause of absence because of sickness in
developed countries ; they are second only to
respiratory disorders as a cause of short-term sickness
absence (less than two weeks) .
• Are the most common medical causes of long term
absence, accounting for more than half of all sickness
absences lasting longer than two weeks in Norway.
Global burden of osteoarthritis in the year 2000, Deborah Symmons, Colin Mathers, Bruce Pfleger

19. Impact of musculoskeletal disorders on society
Sprains, pains
and tears
75.8%
Carpel Tunnel
Syndrome
4.5%
MSD systems &
connective tissue
disrders except
tendonitis
1.8%
Tendonitis
1.7%
Soreness, pain
except back
5.3%
Back pain & hurt
back
6.3% 4.6%
Hernia
Reference : http://www.usbjd.org/research/research_op.cfm?dirID=211, accessed on 28/1/2013
Resources :
1. American Academy of Orthopaedic Surgeons - www.aaos.org. 2. American College of Surgeons - www.facs.org/trauma/ntdbannualreport2003.pdf
3. Orthopaedic Trauma Association -www.ota.org

20. Facts About Acute Ankle Injury
▹ Acute ankle injury is one of the most common
musculoskeletal injuries in athletes and sedentary persons.
▹ It is accounting for an estimated 2 million injuries per year
and 20 % of all sports injuries in the United States.1-3
▹ Inadequate treatment of ankle sprains can lead to chronic
problems such as:4
− decreased range of motion,
− pain, and
− joint instability.
References from 1-4 are stated in Acute Ankle Sprain: An Update, Douglas Ivins, Am Fam Physician 2006;74:1714-20, 1723-4, 1725-6.

21. The immediate goals of treating acute ankle sprain are to:1
▹ Decrease pain and swelling and,
▹ Protect ankle ligaments from further injury.
▹ The PRICE (Protection, Rest, Ice, Compression, Elevation)
treatment protocol for acute ankle injury is commonly used.
▹ The protocol includes elevating the ankle and protecting it with
a compressive device. Ice is applied to the injured ankle, and the
patient is advised to rest for up to 72 hours to allow the ligaments
to heal.
Reference 1 is stated in Acute Ankle Sprain: An Update, Douglas Ivins, Am Fam Physician 2006;74:1714-20, 1723-4, 1725-6.
Treatment Goals of Acute Ankle Sprain

22. Pain Management with NSAIDs

23. NSAIDs – the chemical family
Indole & Indenyl acetic
acids
•Etodalac
•Indomethacin
•Sulindac
Araylacetic acids
•Diclofenac
•Aceclofenac
•Ketorolac
•Tolmetin
Enolic acids
•Meloxicam
•Nabumetone
•Piroxicam
•Tenoxicam
•Phenylbutazone
Anilides
•Acetaminophen/
Paracetamol
Arylpropionic acids
•Flurbiprofen
•Ibuprofen
•Ketoprofen
•Naproxen
Salicylic acids
•Acetylsalicylic acid
•Diflunisal
Anthranillic acids
•Clofenamic acid
•Mefenamic acid
Others
•Nimesulide
Classification of non-steroidal anti-inflammatory drugs[internet].[cited 2009 Oct 2]. Available from: http:// www.rphworld.com/pharmacist/viewlink-22970.html 2

24. Mechanism of action of NSAIDs
https://thepainsource.com/nsaids-pain-medicine/

25. Criteria for an optimal NSAID
Has rapid analgesic effect
Possesses potent
anti inflammatory action
Produces least possible adverse
effects (short half-life)
https://www.emedexpert.com/compare/nsaids.shtml

26. Diclofenac Clinical Trials

27. The Diclofenac-K/Sumatriptan Migraine Study Group
METHOD: Single oral doses of 50 mg and 100 mg diclofenac-potassium were compared
to a single oral dose of 100 mg sumatriptan and placebo in a double-blind randomized
crossover trial in 156 adult patients suffering from migraine attacks, with or without aura,
selected according to the International Headache Society diagnostic criteria.
The primary efficacy criterion was migraine headache pain recorded on a visual analog
scale at 2 h after dosing.
Secondary endpoints included pain at other time points up to 8 h and the presence of
accompanying symptoms (nausea, vomiting, photophobia, phonophobia).
Acute treatment of migraine attacks: efficacy and safety of a nonsteroidal anti-inflammatory drug, diclofenac-potassium, in comparison to oral sumatriptan and placebo. The
Diclofenac-K/Sumatriptan Migraine Study Group. Cephalalgia. 1999 May;19(4):232-40. doi: 10.1046/j.1468-2982.1999.019004232.x. PMID: 10376168.

28. The Diclofenac-K/Sumatriptan Migraine Study Group
Compared with placebo and the reference therapy sumatriptan, diclofenac-potassium is an effective, fast-acting, and
well-tolerated acute oral therapy for migraine attacks, with advantages over oral sumatriptan in terms of onset of
analgesic effect, reduction of accompanying symptoms, and tolerability profile.
Acute treatment of migraine attacks: efficacy and safety of a nonsteroidal anti-inflammatory drug, diclofenac-potassium, in comparison to oral sumatriptan and placebo. The
Diclofenac-K/Sumatriptan Migraine Study Group. Cephalalgia. 1999 May;19(4):232-40. doi: 10.1046/j.1468-2982.1999.019004232.x. PMID: 10376168.

29. Diclofenac K in Management of URTIs
Caballero M. Diclofenac Potassium in the Treatment of Upper Respiratory Disorders: A Multicentric Investigation in Mexico, Investigation Medica International
1987;14(61); p 61-72

30. Diclofenac K – An adjuvant therapy
• Have rapid onset of action which makes them particularly suitable for acute and
inflammatory conditions
• Effectively reduced oral temperature and spontaneous throat pain and pain on
swallowing in patients with benign acute febrile sore throat.
• As an adjuvant in severe painful inflammatory infections of the ear, nose or
throat, e.g.: pharyngotonsilitis, otitis.
Gehanno P, Dreiser RL, Ionescu E, Gold M, Lowest effective single dose of fdiclofenac for anti pyretic and analgesic effects in acute febrile sore throat. Clin
Drug Invest. 2003; 23 (4): 263-271

31. Wide benefits in varied inflammatory conditions
• Diclofenac K anti-inflammatory agents enable patients to return
faster to normal daily activities1
• Rapid relief of signs and symptoms in acute pharyngitis and
tonsillitis4
• Greatly reduced pharyngeal pain2
• Rapid and effective treatment of acute otitis externa3
• Greatly controlled fever2
1. Batista N.A, et al. A Double-Blind Comparison of Diclofenac Resinate Drops and Benzidamine in Combination with an Antibiotic in Infections of the Upper
Airways in Children. Arch Bras Med (BR) Match/April 1986; 60 (2): p 149-153.
2. Caballero M. Diclofenac Potassium in the Treatment of Upper Respiratory Disorders: A Multicentric Investigation in Mexico, investigation Medica International 1987; 14 (61): p
61-72.
3. Gutierrez CV, Gutierrez PV. Diclofenac potassium vs. placebo in acute external otitis. Comparative double-blind study. International Medical Investigation 1987; 14: 56-60.
4. Ayres W, Sole Puyo JM. Comparative evaluation of the efficacy and tolerability for the diclofenac potassium, a new drug in the treatment of pharyngo-tonsillitis. Arq Bras Med
1984; 58 (5): 341-9.

32. Diclofenac in major Orthopedic surgery – to reduce post-
operative morphine use
Alexander R, El-Moalem HE, Gan TJ. Comparison of the morphine-sparing effects of diclofenac sodium and ketorolac tromethamine after major orthopedic surgery. J Clin
Anesth 2002; 14 (3): 187-92.
Objective:
To compare the efficacy of Diclofenac Na 75 mg IV with Ketorolac in reducing
postoperative morphine use after major orthopedic surgery.
Design:
• Double blind, randomized, placebo-controlled study.
• 102 patients undergoing hip& knee replacement.
• We assess every 4 hrs:
1) Visual analouge scale (VAS).
2) Verbal pain score (VPS).
3) Sedation score.
4) Frequency of opioid side effects.
5) Morphine consumption.

33. Study results
Conclusions: Preoperative administration of intravenous diclofenac 75 mg or ketorolac 60 mg significantly reduces
morphine requirements and associated side effects after major orthopedic surgery.
0
10
20
30
40
50
60
Diclofenac 75 mg Ketorolac 60 mg Placebo
36.3
47.2
51.6
mean (SD) 24-hour morphine requirements (mg)

34. Diclofenac Na IV: Effective reduction of pain compared to Ketoprofen
after knee arthroplasty
Objective:
Compare the effect of Diclofenac Na IV to Ketoprofen in pain
reduction after knee arthroplasty.
Design:
A randomized, double blind study.
64 knee arthroplasty patients .
Patients recieved either Diclofenac Na 75 mg IV, Ketoprofen 100
mg or saline.
Silvanto M, Lappi M, Rosenberg PH. Comparison of the opioid-sparing efficacy of diclofenac and ketoprofen for 3 days after knee arthroplasty. Acta Anaesthesiol
Scand 2002; 46 (3): 322-8

35. Study results
Conclusion: We conclude that in the first day after knee arthroplasty (13-24 h), ketoprofen exerted an opioid-sparing effect.
After day 1 (25-60 h), with the doses used, diclofenac proved to be better than placebo, whereas ketoprofen was not.
Diclofenac Na
Silvanto M, Lappi M, Rosenberg PH. Comparison of the opioid-sparing efficacy of diclofenac and ketoprofen for 3 days after knee arthroplasty. Acta Anaesthesiol

36. Diclofenac Na: Effect of a non-steroidal anti-inflammatory drug, diclofenac, on
haemostasis in patients undergoing total hip replacement
Objective:
Effect of Diclofenac Na on haemostasis in patients undergoing
total hip replacement.
Design:
A double blind study.
38 patients undergoing total hip replacement.
They were given immediately postoperatively Diclofenac Na 75
mg IV over 60 min. followed by an infusion of 5 mg/hr for 15 h., or
an equal volume of saline.
The measurements were performed postoperatively, 3 HR
postoperatively and on the 4th & 8th postoperative days.
Laitinen J, Nuutinen LS, Puranen J, Ranta P, Salomäki T. Effect of a non-steroidal anti-inflammatory drug, diclofenac, on haemostasis in patients undergoing total hip
replacement. Acta Anaesthesiol Scand 1992; 36 (5): 486-9.

37. Study results
Conclusion: It is concluded that diclofenac given as an intravenous infusion of 75 mg in 60 min, then 5 mg/h for 15 h,
followed by 50 mg every 8 h orally, is a safe as dextropropoxyfen for pain relief in patients undergoing major orthopaedic
surgery as far as coagulation data are concerned.
Diclofenac Na
Laitinen J, Nuutinen LS, Puranen J, Ranta P, Salomäki T. Effect of a non-steroidal anti-inflammatory drug, diclofenac, on haemostasis in patients undergoing total hip replacement.
Acta Anaesthesiol Scand 1992; 36 (5): 486-9.
Diclofenac Na

38. Diclofenac Na IM: More effective than Pethidine in relief of renal colic
pain after a single-injection
Objective:
Compare the efficacy and tolerability of Diclofenac Na IM 75 mg with
those of the commonly prescribed narcotic Pethidine 100 mg in the
management of acute renal colic.
Design:
58 patients with acute renal colic suffering from severe pain.
Double blind, randomized.
Pain assessed on a scale from 0 to 5 (0=no pain at all, 5=the most
severe pain imaginable).
Treatment was regarded as successful if the pain score improved by
three points or more.
Hetherington JW, Philp NH. Diclofenac sodium versus pethidine in acute renal colic. BRITISH MEDICAL JOURNAL 1986; 292 (6515): 237–238

39. Study results
Conclusion: We conclude that diclofenac sodium 75 mg intramuscularly is more effective than pethidine 100 mg
intramuscularly in the management of acute renal colic and has fewer side effects.
Hetherington JW, Philp NH. Diclofenac sodium versus pethidine in acute renal colic. BRITISH MEDICAL JOURNAL 1986; 292 (6515): 237–238
Drugs No. of
patients
Satisfactory ( 3 point
improvement)
Mild improvement (1-2
points)
None
Diclofenac Na 30 28 2 0
Pethidine 28 18 5 5
>
• Side effects occurred in 50% of patients receiving Pethidine Comparing to only
17% of patients receiving Diclofenac Na IM.
• Side effects included nausea, vomiting, drowsiness.

40. Diclofenac Na IM: Effective biliary colic pain relief compared to Butyl-
Scopolamine
Objective:
To assess efficacy of Diclofenac Na IM to relief biliary colic pain comparing to
Butyl-Scopolamine.
Design:
A randomized, double blind study.
Patients were randomly allocated to treatment with:
Diclofenac Na 75 mg IM (n=16) or 20 mg butyl-scopolamine bromide (n=14).
Pain was assessed before treatment and after 30 and 60 min using 100 mm
VAS.
Grossi E, Broggini M, Quaranta M, Balestrino E. Different pharmacological approaches to the treatment of acute biliary colic. Current Therapeutic Research 1986; 40 (5): 876-882.

41. Study results
Diclofenac Na
Grossi E, Broggini M, Quaranta M, Balestrino E. Different pharmacological approaches to the treatment of acute biliary colic. Current Therapeutic Research 1986; 40 (5): 876-882.

42. Conclusion
• Pain in biliary colic is induced by an increased pressure in the gallbladder lumen.
• PGs appear to be an important factor in raising gallbladder pressure.
• Belladonna alkaloids derivatives ( butyl-scopolamine) exert a mild antispasmodic
action on the gallbladder but have no consistent effect.
• From theoretical point of view there is a little basis for the use of these agents to
reduce tone and motility when administrated in maximum tolerated doses.
• From practical point of view Diclofenac sodium appear to be a good choice in
management of biliary colic and it is more effective than anticholinergics.
Grossi E, Broggini M, Quaranta M, Balestrino E. Different pharmacological approaches to the treatment of acute biliary colic. Current Therapeutic Research 1986; 40 (5): 876-882.

43. Diclofenac Na Suppository: offers 35% morphine sparing
effect
Objective:
To evaluate the hypothesis that Diclofenac Na supp. 100 mg twice daily reduce opioid
consumption after caesarean sections.
Design:
84 women.
Randomized, double blind, placebo controlled.
Dahl V, Hagen IE, Sveen AM, Norseng H, Koss KS, Steen T. High-dose diclofenac for postoperative analgesia after elective caesarean section in regional anaesthesia.
Int J Obstet Anesth 2002; 11(2): 91-4.

44. Study results
Dahl V, Hagen IE, Sveen AM, Norseng H, Koss KS, Steen T. High-dose diclofenac for postoperative analgesia after elective caesarean section in regional anaesthesia.
Int J Obstet Anesth 2002; 11(2): 91-4.

45. Study results
Dahl V, Hagen IE, Sveen AM, Norseng H, Koss KS, Steen T. High-dose diclofenac for postoperative analgesia after elective caesarean section in regional anaesthesia.
Int J Obstet Anesth 2002; 11(2): 91-4.
• We found that the use of Diclofenac Na supp. 100 mg twice
daily was opioid –sparing.
• With none experiencing side effects in Diclofenac Na group, we
suggest that reduced need of morphine reduces the
incidence of postoperative nausea and vomiting.

46. Diclofenac Na Suppository: Effectively reduce the intensity of
pain at rest & on movement.
Objective :
Comparing the efficacy of Diclofenac Na supp. 100 mg and Indomethacin
in relieving Symptoms of rheumatoid arthritis.
Design:
30 patients.
Double blind, randomized, cross over study.
2 weeks.( 6 days with Diclofenac Na following 2 days with placebo and
6 days with Indomethacin).
Wafin F, Valindas E, Wuolijoki E. Comparison of diclofenac&Indomethacin suppositories in rheumatoid arthritis. Clin Rheumatol 1984; 3 (1):67-70.

47. Study results
Wafin F, Valindas E, Wuolijoki E. Comparison of diclofenac&Indomethacin suppositories in rheumatoid arthritis. Clin Rheumatol 1984; 3 (1):67-70.
0
0.5
1
1.5
2
2.5
3
At Rest On movement
1.9
3
1.5
2.3
Reduction in Pain score with Diclofenac 100mg
21% reduction 23% reduction

48. Conclusion
Wafin F, Valindas E, Wuolijoki E. Comparison of diclofenac&Indomethacin suppositories in rheumatoid arthritis. Clin Rheumatol 1984; 3 (1):67-70.
• The status of the disease was statistically significantly improved during
both Diclofenac Na and Indomethacin, the two drugs being equally
effective.
• The effects on pain at rest and on movement, as well as on morning
stiffness, were equally good with both drugs as compared to the situation
before the treatment.
• When compared to each other no statistically significant difference
was found between the two drugs.

49. Diclofenac Na Suppository: Significantly lowers mean pain scores
after cesarean section
Objective :
The aim of this study was to compare the analgesic effects of Diclofenac Na supp. And
Pethidine in post-cesarean section (C/S) patients.
Design:
• 240 women were randomly divided to two groups:
• Group A: received Diclofenac Na supp. 100 mg.
• Group B:received pethidine 1 mg/kg IM.
• Both groups received their treatment after operation at the end of operation and 8, 16
and 24 hours after the operation.
• The pain scores were assessed at 2, 10, 18 and 26 hours after C/S using (VAS).
Soroori ZZ, Sharami SH, Heidarzadeh A, Shokri L.The comparison between suppository diclofenac and pethidine in post-cesarean section pain relief: a randomized controlled
clinical trial. Journal of research in Medical Sciences 2006; 11(5):292-296

50. Study assessment
6.8
2.05
1.4
0.5
7.3
2.6
2.3
1.3
0
1
2
3
4
5
6
7
8
2 hr 10 hr 18 hr 26 hr
Assessment of Pain Scores
Diclofenac Supp Pethidine IM
Soroori ZZ, Sharami SH, Heidarzadeh A, Shokri L.The comparison between suppository diclofenac and pethidine in post-cesarean section pain relief: a randomized controlled
clinical trial. Journal of research in Medical Sciences 2006; 11(5):292-296

51. Conclusion
Soroori ZZ, Sharami SH, Heidarzadeh A, Shokri L.The comparison between suppository diclofenac and pethidine in post-cesarean section pain relief: a randomized
controlled clinical trial. Journal of research in Medical Sciences 2006; 11(5):292-296
• The study results showed that the use of Diclofenac Na supp. Is an appropriate
replacement therapy for pain relief after C/S.
• Pethidine is one of the most effective opioids for pain relief after C/S, but general concerns
have been raised for its wide side effects. It seems that diclofenac suppository is a suitable
replacement therapy for this drug because it has shown better analgesic effects on
postoperative pain.

52. Diclofenac Na Suppository: offers 33% reduction in epidural local
anesthetic/opioid requirements
Objective:
To evaluate the hypothesis that single administration of Diclofenac Na supp. 100 mg
reduce post-cesareanepidural local anesthetic/opioid requirements.
Design:
• 48 women ( all have epidural analgesia).
• Randomized, double blind study.
Results:
Single administrationof 100 mg Diclofenac Na suppository is effective in reducing post-
cesarean epidural local anesthetic/opiod requirements by 33% .
Lim NL, Lo WK, Chong JL, Pan AX. Single dose diclofenac suppository reduces post-Cesarean PCEA requirements. Can J Anaesth 2001; 48 (4):.383-6

53. Diclofenac K Tablet: 50% Reduction in Pain Associated with Ankle Sprain Within 2
Hours from Baseline
1. Morán M. An observer-blind comparison of diclofenac potassium, piroxicam and placebo in the treatment of ankle sprains. Curr Med Res Opin 1990; 12 (4): 268-74

54. Diclofenac K Tablet : Significant Reduction in Traumatic Pain Within 2
Hours from Base line
1. Morán M. An observer-blind comparison of diclofenac potassium, piroxicam and placebo in the treatment of ankle sprains. Curr Med Res Opin 1990; 12 (4): 268-74.

55. Diclofenac K Tablet : Significantly more effective in controlling swelling than Etodolac
and Naproxen Sodium on postoperative sequels following third molar surgery
Akbulut N, Ustuner E, Atakan C, Colok C Comparison of the effect of naproxen, etodolac and diclofenac on postoperative sequels following third molar surgery; a
randomized, double blind, crossocer study. Med oral Patol oral Cir Bucal. 2014;19(2):e 149-156
Objective:
To compare the three non-steroidal anti-inflammatory agents (NSAIDs) Diclofenac potassium,
Etodolac and Naproxen sodium in relation to pain, swelling and trismus following impacted third
molar surgery.
Design:
• 42 healthy young individuals with impacted third molars and bone retention.
• Patients were randomly assigned to 3 groups (n: 14) to which Diclofenac potassium, Naproxen
sodium and Etodolac were administered orally an hour before the operation
Visual analog scales (VAS) were used to assess the pain in the 6th, 12th hours and on the 1st, 2nd,
3rd, 5th, and 7th days postoperatively.
Swelling was evaluated using ultrasound (US) and mouth opening (trismus) was measured with a
composing stick pre and post operatively on the 2nd and 7th days respectively.

56. Reduction in swelling - comparison
The swelling on postoperative 2nd
day was significantly lowest with
Diclofenac potassium as compared to
others
(p= 0.027)
Akbulut N, Ustuner E, Atakan C, Colok C Comparison of the effect of naproxen, etodolac and diclofenac on postoperative sequels following third molar surgery; a
randomized, double blind, crossocer study. Med oral Patol oral Cir Bucal. 2014;19(2):e 149-156

57. Diclofenac SR 75mg – Proven efficacy in the management of knee
osteoarthritis
1. Case JP, Baliunas AJ, Block JA. Lack of efficacy of acetaminophen in treating symptomatic knee osteoarthritis: a randomized, double-blind,
placebo-controlled comparison trial with diclofenac sodium. Arch Intern Med. 2003;163(2):169-178
-53.9
-30.7
-163
-15.3 -17.1
-85.6
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
Pain Stiffness Function
Diclofenac Placebo
**P = 0.001 vs baseline
WOMAC
$
mean
reduction
from
baseline
***P < 0.001 vs baseline
*
**
***
A randomized, double-blind, placebo controlled trial evaluating the efficacy of diclofenac sodium 75mg
twice daily and placebo in the treatment of patients with knee osteoarthritis for 12 weeks
*P = 0.002 vs baseline
n=25 n=28
Numerical rating scale. $ Western Orlando and McMaster Universities osteoarthritis index

58. Diclofenac 100mg Retard
Superior analgesic efficacy vs traditional NSAIDs
1. C.K.S. Ong, DDS, PhD; P. Lirk, MD; C.H. Tan, MD, PhD; and R.A. Seymour, DDS, PhD. An Evidence-Based Update on Nonsteroidal Anti-Inflammatory Drugs.
Clinical Medicine & Research Volume
Randomized, double-blind studies evaluating the efficacy of single-dose of different analgesic
agents compared to placebo in patients with moderate to severe pain over 4-6 hours
Percentage
of
patients
with
at
least
50%
pain
relief
over
4-6
hours
0%
10%
20%
30%
40%
50%
60%
70%
Votaren
100mg n= 411
Piroxicam
20mg n= 280
Ibuprofen
400mg n=
4703
Ketorolac
10mg n= 790
Naproxen
550mg n= 169
67%
63%
56%
50%
46%

59. Diclofenac 100mg shows superior analgesic effect over celecoxib
http://www.bandolier.org.uk/booth/painpag/Acutrev/Analgesics/lftab.html
Percentage
of
patients
with
at
least
50%
pain
relief
over
4-6
hours
Randomized, double-blind studies evaluating the efficacy of single-dose of different analgesic
agents compared to placebo in patients with moderate to severe pain over 4-6 hours
69%
52%
0%
10%
20%
30%
40%
50%
60%
70%
80%
Voltaren 100mg n= 545 Celecoxib 400mg n= 298

60. Diclofenac Na® proved safety in the special populations
Stierlin H, Faigle JW, Colombi A. Pharmacokinetics of Diclofenac Sodium (Diclofenac Na) And Metabolites in Patients with Impaired Renal Function. Scandinavian Journal of
Rheumatology 1978; 7 (22): 30-35.
Catalano MA. Worldwide Safety Experience with Diclofenac. The American Journal of Medicine 1986; 80 (4B): 81-87.
The pharmacokinetic parameters of Diclofenac
Na® are not markedly altered in patients with
mild to moderate degrees of hepatic
impairment.2
Elimination rate of Diclofenac Na ® (Diclofenac
Sodium) from plasma after the first 24 hours was
the same in the patients with the highest degree
of renal dysfunction as in the healthy subjects.1

61. Diclofenac role in current era of pain management
Since its introduction, the original diclofenac sodium drug product has been modified using
pharmaceutical technology
Alteration of the pharmacokinetic properties of oral diclofenac drug products produced a
number of desirable characteristics, including more convenient dosing, improved absorption,
and rapid onset of analgesia
Recently, a new technology that reduces drug particle size has been used to develop low-dose
oral diclofenac products that provide analgesic efficacy with low systemic exposures
Roy Altman1 • Bill Bosch2 • Kay Brune3 • Paola Patrignani4 • Clarence Young5 Drugs (2015) 75:859–877

62. Any questions?
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