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      Comparison of safety and analgesic efficacy of diclofenac sodium with etodolac after surgical extraction of third molars: a randomized, double-blind, double-dummy, parallel-group study

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          Abstract

          Background

          Surgical extraction of third molars is associated with postoperative pain and swelling at the extraction site. Pain is commonly managed using non-steroidal anti-inflammatory drugs (NSAIDs). Postoperative pain is usually moderate to severe in the first 12 h postoperatively and lasts for 3–5 days. However, with NSAIDs, these symptoms usually subside within 24 h. Diclofenac sodium and etodolac are NSAIDs, more selectively cyclooxygenase-2 inhibitors, with good analgesic efficacies.

          Methods

          We compared the safety and analgesic efficacy of diclofenac sodium with etodolac peroral after surgical extraction of third molars in a double-blind, double-dummy, parallel-group study. The subjective pain improvement and pain relief after 2, 6, 24, 48, and 72 h using the visual analogue scale were measured as the study outcome.

          Results

          Etodolac was equivalent to diclofenac sodium in pain alleviation at all postoperative time periods. No significant differences were found between diclofenac sodium and etodolac groups (P > 0.05). Both study medications were well tolerated and safe with mild adverse effects in only a few participants.

          Conclusion

          Diclofenac sodium and etodolac are comparable in terms of analgesic efficacy and safety after surgical removal of third molars.

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          Most cited references34

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          Diclofenac: an update on its mechanism of action and safety profile.

          Tong Gan (2010)
          Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions. As with all NSAIDs, diclofenac exerts its action via inhibition of prostaglandin synthesis by inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) with relative equipotency. However, extensive research shows the pharmacologic activity of diclofenac goes beyond COX inhibition, and includes multimodal and, in some instances, novel mechanisms of action (MOA). Literature retrieval was performed through PubMed/MEDLINE (through May 2009) using combinations of the terms diclofenac, NSAID, mechanism of action, COX-1, COX-2, and pharmacology. Reference citations resulting from publications identified in the literature search were reviewed when appropriate. This article reviews the established, putative, and emerging MOAs of diclofenac; compares the drug's pharmacologic and pharmacodynamic properties with other NSAIDs to delineate its potentially unique qualities; hypothesizes why it has been chosen for further recent formulation enhancement; and evaluates the potential effect of its MOA characteristics on safety. Research suggests diclofenac can inhibit the thromboxane-prostanoid receptor, affect arachidonic acid release and uptake, inhibit lipoxygenase enzymes, and activate the nitric oxide-cGMP antinociceptive pathway. Other novel MOAs may include the inhibition of substrate P, inhibition of peroxisome proliferator activated receptor gamma (PPARgamma), blockage of acid-sensing ion channels, alteration of interleukin-6 production, and inhibition of N-methyl-D-aspartate (NMDA) receptor hyperalgesia. The review was not designed to compare MOAs of diclofenac with other NSAIDs. Additionally, as the highlighted putative and emerging MOAs do not have clinical data to demonstrate that these models are correct, further research is necessary to ascertain if the proposed pathways will translate into clinical benefits. The diversity in diclofenac's MOA may suggest the potential for a relatively more favorable profile compared with other NSAIDs.
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            The effect of a single dose prednisolone with and without diclofenac on pain, trismus, and swelling after removal of mandibular third molars.

            Metin Gungormus, Omer Kaya, M Buyukkurt (2006)
            The purpose of this study was to evaluate the effect of a single intramuscular dose of prednisolone and the prednisolone-diclofenac combination on postoperative pain, trismus, and edema after the removal of third molars. Forty-five patients who were to undergo surgical removal of lower third molars were studied. Patients were divided into 3 groups. In the first group, each patient was given 25 mg prednisolone intramuscularly immediately after surgery. In the second group, each patient was given 25 mg prednisolone and diclofenac intramuscularly immediately after surgery, and in the third group, each patient was given sterile saline solution as control group. Postoperative pain was evaluated by visual analogue scale on the day of surgery. Facial swelling and trismus were evaluated on postoperative days 2 and 7. ANOVA was used to analyze these data. Statistical analysis of the data indicated the prednisolone-diclofenac combination suppressed pain intensity in comparison with control (P < .05) at the 6-hour observation. Both the prednisolone and prednisolone-diclofenac combinations suppressed pain at the seventh postoperative hour in comparison with the control (P < .05). The prednisolone-diclofenac combination group also had a smaller loss of opening at postoperative days 2 and 7 in comparison with both the prednisolone and control groups (P < .05). Postoperative swelling was less in both the prednisolone and prednisolone-diclofenac combination groups, as compared with the control group (P < .05) at postoperative day 2. The prednisolone-diclofenac combination group also had a smaller swelling at postoperative day 7 in comparison with both the prednisolone and control groups (P < .05). It was determined that the combination of a single dose of prednisolone and diclofenac is well-suited to the treatment of postoperative pain, trismus, and swelling after dental surgical procedures and should be used when extensive postoperative swelling of soft tissue is anticipated.
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              Analgesic safety and efficacy of diclofenac sodium softgels on postoperative third molar extraction pain.

              Raymond Peroutka, Matthew C L Phillips, Charles Bon … (2004)
              The purpose of this single-blind, placebo-controlled, 3-arm parallel, randomized study was to compare the analgesic efficacy and tolerability of a single dose of 100 mg diclofenac potassium (Cataflam; Novartis, Stein, Switzerland), 100 mg diclofenac sodium softgel, and placebo in patients experiencing moderate to severe postoperative pain after third molar extraction. Seventy-five patients (67% female with a mean age of 23, age range 18 to 34.5 years) participated in the study following removal of at least 1 impacted mandibular third molar. Patients received a single dose of study medication when their postoperative pain reached a moderate or severe intensity. Analgesic efficacy measures included the time to meaningful pain relief measured using a stopwatch and time to rescue medication. Pain relief (PR) and Pain intensity (PI) ratings were recorded at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours postdosing. Summary analgesic measures, including Summed Pain Relief Score (TOTPAR) and Summed Pain Intensity Differences (SPID), were calculated from the 0.25- to 6-hour responses. The time between pain relief and rescue and a global evaluation for the effectiveness of the study medications were recorded at the end of the study. Seven scheduled blood samples were collected from each patient for determining plasma concentrations of diclofenac anion. Both diclofenac sodium softgel and Cataflam were significantly more effective than placebo (P <.0001) for all summary analgesic measures. The average overall pain relief was substantially better from diclofenac sodium softgel than from Cataflam, but the difference was not statistically significant (P =.14). In patients taking diclofenac sodium softgel, 50% of the patients experienced a time to onset of analgesic activity within 18 minutes and the median analgesic duration was 5 hours (302 minutes). Fifty percent of the patients taking Cataflam had a time to onset of action within 38 minutes, and the median duration of analgesia was 4.5 hours (272 minutes). At the time of rescue drug administration or 6 hours, whichever was earlier, 72% of the patients given diclofenac sodium softgel rated the medication as a very good or excellent pain reliever, whereas only 45% of the patients taking Cataflam gave these ratings. No serious adverse events were observed in this study. The mean concentrations of diclofenac from the diclofenac sodium softgel formulation were significantly different from the Cataflam formulation. The mean C(max) for the softgel was almost twice that of Cataflam and C(max) was reached an hour earlier, on average. More diclofenac anion was absorbed at a quicker rate using the formulation diclofenac sodium softgel 100 mg than Cataflam. The softgel provided a very rapid onset of analgesic activity, a prolonged analgesic duration, and an acceptable side-effect profile in the postoperative third molar surgery pain model. In an acute pain situation, the rapid absorption of nonsteroidal anti-inflammatory drugs from a formulation like the Softgel may positively affect the time of onset and duration of inflammatory pain compared with other commercially available nonsteroidal anti-inflammatory drug formulations.
              Article 0 comments Cited 16 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Dent Anesth Pain Med
                Journal ID (iso-abbrev): J Dent Anesth Pain Med
                Journal ID (publisher-id): JDAPM
                Title: Journal of Dental Anesthesia and Pain Medicine
                Publisher: The Korean Dental Society of Anesthsiology
                ISSN (Print): 2383-9309
                ISSN (Electronic): 2383-9317
                Publication date (Print): February 2020
                Publication date (Electronic): 28 February 2020
                Volume: 20
                Issue: 1
                Pages: 19-27
                Affiliations
                [1 ]Department of Pharmacology, NAMO Medical College & Research Institute, Silvassa, Dadra and Nagar Haveli, India.
                [2 ]Department of Dentistry, Sir Takhtasinhji General Hospital & Government Medical College, Bhavnagar, Gujarat, India.
                [3 ]Department of Pharmacology, Government Medical College, Bhavnagar, Gujarat, India.
                Author notes
                Corresponding Author: Jigna H. Shah, Department of Dentistry, Sir Takhtasinhji General Hospital & Government Medical College, Bhavnagar-364001, Gujarat, India. Tel: +919925205554, Fax: +912782422011, dr.jigna71@ 123456gmail.com
                Author information
                https://orcid.org/0000-0002-8040-662X
                https://orcid.org/0000-0003-0198-4008
                https://orcid.org/0000-0003-4808-1105
                https://orcid.org/0000-0001-9462-185X
                Article
                DOI: 10.17245/jdapm.2020.20.1.19
                PMC ID: 7054068
                PubMed ID: 32158956
                SO-VID: 38bfc697-953f-4f88-96ba-efa7f4d6322b
                Copyright © Copyright © 2020 Journal of Dental Anesthesia and Pain Medicine
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 11 November 2019
                Date revision received : 10 January 2020
                Date accepted : 09 February 2020
                Categories
                Subject: Original Article

                Keywords: diclofenac,etodolac,pain,third molar,tooth extraction,visual analog scale
                Data availability:
                Keywords: diclofenac, etodolac, pain, third molar, tooth extraction, visual analog scale

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