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Year : 2013  |  Volume : 4  |  Issue : 2  |  Page : 144-145  

Efficacy of aceclofenac and diclofenac sodium for relief of postoperative pain after third molar surgery: A randomised open label comparative study

1 Department of Oral and Maxillofacial surgery, BVU Dental College, Sangli, Maharashtra, India
2 Department of Oral and Maxillofacial surgery, SB Patil Dental College, Bidar, Karnataka, India
3 Department of Oral and Maxillofacial surgery, Pananeeya Dental College, Hyderabad, Andhra Pradesh, India
4 Department of Periodontics, GITAM Dental College, Vishakapatnam, Andhra Pradesh, India
5 Department of Oral and Maxillofacial surgery, Kalinga Institute of Dental sciences, Bhubneswar, Odisha, India

Date of Web Publication20-Apr-2013

Correspondence Address:
Nagendra S Chunduri
Department of Oral and Maxillofacial Surgery, BVDU Dental College and Hospital, Sangli, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0976-500X.110910

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How to cite this article:
Chunduri NS, Kollu T, Goteki VR, Mallela KK, Madasu K. Efficacy of aceclofenac and diclofenac sodium for relief of postoperative pain after third molar surgery: A randomised open label comparative study. J Pharmacol Pharmacother 2013;4:144-5

How to cite this URL:
Chunduri NS, Kollu T, Goteki VR, Mallela KK, Madasu K. Efficacy of aceclofenac and diclofenac sodium for relief of postoperative pain after third molar surgery: A randomised open label comparative study. J Pharmacol Pharmacother [serial online] 2013 [cited 2022 Jan 23];4:144-5. Available from:


Surgical removal of impacted third molar is the common surgical procedure in oral and maxillofacial surgery, which can result in considerable post-operative pain, swelling and trismus. Postoperative pain is an acute localized pain of varying intensity caused by increased prostaglandin synthesis. Pain reaches maximum intensity within 3-5 h postoperatively. [1] Non steroid antiinflammatory drugs (NSAID) are the staples of acute pain therapy, among which diclofenac sodium is one of the potent and time tested, commonly prescribed drug. Diclofenac is a non-selective inhibitor of cyclooxygenase and also appears to reduce synthesis of leukotrienes. Being a non-selective inhibitor, it is associated with gastrointestinal adverse effects, thereby limiting its use in patients predisposed to gastrointestinal disease. [2] Aceclofenac has anti-inflammatory properties similar to those of diclofenac and yields good results in the control of dental pain. [3] Aceclofenac, being a predominantly cox-2 inhibitor, demonstrates improved gastrointestinal tolerability compared to conventional NSAIDs. They do not have any significant effect on platelet functions as non-selective inhibitors. [4] Innumerable clinical studies have been done to evaluate the efficacy and safety of orally administered analgesics.

This study was conducted among fifty patients, aged from 18-60 years, who require surgical removal of impacted mandibular third molars. Patients with blood dyscrasias, with peptic ulcer, pregnant women, patients who had NSAID in the previous 24 h, hypersensitivity to any of the drugs used in this study, surgical time in excess of 45 minutes, patients failure to comply with the prescribed medication were excluded from the study. The patients were randomized into two groups; to receive aceclofenac 100 mg twice daily and diclofenac sodium 50 mg eighth hourly. The patients likewise received the questionnaires to be completed in the course of the 24 hours. Each patient evaluated his or her pain symptoms at specified time points (0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24 h. after administration of the study drug.) and recorded them using established rating scales (category grading scale). In addition, adverse effects of the drugs were noted in all cases. Pain intensity was recorded on a four-point scale (0 = none to 3 = severe) at base line and at the same specified times following the administration of a single dose of the study drug. Pain relief was recorded on a five-point scale (0 = none to 4 = complete) at the same post dose time points. In addition, patients rated the study drug using a five-point global evaluation scale (0 = poor to 4 = excellent) at specified post dose time points. Total pain relief over eight hours (TOPAR8), calculated by multiplying the pain relief score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values (up to eight hours). Pain intensity difference (PID), calculated as the baseline pain intensity score minus the pain intensity score at each post dose time point. Summed PID over eight hours (SPID8), calculated by multiplying the PID score at each post dose time point by the duration (in hours) since the preceding time point and then summing these values (up to eight hours).

Early onset of analgesia in aceclofenac group with mean time of 30.6 (±7.34) minutes compared to 72.2 (±21.6) minutes in diclofenac sodium group (P < 0.01). TOPAR8 was 24.5 (±0.43) for aceclofenac group and 17.8 (±3.0) for diclofenac sodium group. TOPAR 24 was 72.7 (±8.54) for aceclofenac group and 58.4 (±12.4) for diclofenac sodium group. SPID8 was 15.1 ± (4.18) for aceclofenac group and 10.0 (±3.55) for diclofenac sodium group (P < 0.03) [Table 1]. The incidence of adverse effects, especially epigastric pain and nausea were significantly more with diclofenac sodium compared to aceclofenac. One patient of aceclofenac group and five patients of diclofenac sodium group complained nausea and gastric irritation [Table 2].
Table 1: Summed pain relief and pain intensity scores

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Table 2: Adverse events profile of study drugs

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Patients' assessment of pain relief also demonstrated significantly greater efficacy with aceclofenac. [3] Kudaravalli Jyothsna et al., in their study found that at the end of 8 hrs of surgery, 39% reduction in pain intensity in aceclofenac group as compared to 27% reduction in the diclofenac group, which was statistically significant. [5] Gastrointestinal side effects like epigastric pain and nausea were greater in the diclofenac sodium group compared to aceclofenac group. Both the drugs do not have any significant effect on platelet function as COX-1 and 2 inhibitors. [4] The use of predominant COX-2 inhibitors has not been possibly reported to have increased the cardiovascular and cerebrovascular adverse effects unlike, selective COX-2 inhibitors. [6] Patient's global assessment was also significantly better for aceclofenac compared with diclofenac. Patient's compliance is also an important factor, which is favourable with aceclofenac. [5] This comparative study demonstrated that Aceclofenac is an effective and superior analgesic in the treatment of moderate to severe acute pain resulting from third molar surgery, with rapid onset and longer duration of action compared to diclofenac. Furthermore, aceclofenac showed tolerability profile superior to diclofenac.

   References Top

1.Joshi A, Parara E, Macfarlane TV. A double-blind randomised controlled clinical trial of the effect of preoperative ibuprofen, diclofenac, paracetamol with codeine and placebo tablets for relief of postoperative pain after removal of impacted third molars. Br J Oral Maxillofac Surg 2004;42:299-306.  Back to cited text no. 1
2.Baraf HS, Fuentealba C, Greenwald M, Brzezicki J, O'Brien K, Soffer B, et al. Gastrointestinal side effects of etoricoxib in patients with osteoarthritis: Results of the Etoricoxib versus Diclofenac Sodium Gastrointestinal Tolerability and Effectiveness (EDGE) trial. J Rheumatol 2007;34:408-20.  Back to cited text no. 2
3.Dooley M, Spencer CM, Dunn CJ. Aceclofenac: A reappraisal of its use in the management of pain and rheumatic disease. Drugs 2001;61:1351-78.  Back to cited text no. 3
4.Catella-Lawson F, Reilly MP, Kapoor SC, Cucchiara AJ, DeMarco S, Tournier B, et al. Cyclooxygenase inhibitors and the antiplatelet effects of aspirin. N Engl J Med 2001;345:1809-17.  Back to cited text no. 4
5.Jyothsna K, Deshpande N, Vijayalakshmi G. Efficacy and safety of diclofenac sodium and aceclofenac in controlling post extraction dental pain: A randomised open label comparative study. J Pharmacol Toxicol 2011;6:541-7.  Back to cited text no. 5
6.Burke A, Smyth EM, Gerald GA. Analgesic- Antipyretic Agents. In: Laurence LB, John SL, Keith LP, editors. Goodman and Gilman's. The Pharmacological Basis of Therapeutics. 11 th ed. New York, USA: McGraw Hill; 2005. p. 684-5.  Back to cited text no. 6


  [Table 1], [Table 2]

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