Placebo

Int. J. Oral Maxillofac. Surg. 2009; 38: 350–355 doi:10.1016/j.ijom.2008.12.013, available online at http://www.sciencedirect.com

Clinical Paper Oral Medicine

A randomized, double-blind, placebo-controlled study comparing the efficacy and safety of paracetamol, serratiopeptidase, ibuprofen and betamethasone using the dental impaction pain model
D. Chopra, H. S. Rehan, P. Mehra, A. K.Kakkar: A randomized, double-blind, placebo-controlled study comparing the efficacy and safety of paracetamol, serratiopeptidase, ibuprofen and betamethasone using the dental impaction pain model. Int. J. Oral Maxillofac. Surg. 2009; 38: 350–355. # 2008 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved. Abstract. Assessment of postoperativesequelae following the removal of an impacted third molar has been used in clinical pharmacology to evaluate the relative efficacy of various analgesic, anti-inflammatory drugs. This study included 150 patients with impacted lower third molars. They were randomly sorted to receive ibuprofen, paracetamol, betamethasone, serratiopeptidase or placebo. Evaluation of efficacy was made using tape measurement(for swelling), visual analogue scale (for pain evaluation), mouth opening ability and oral temperature. The effect of treatment on hematological parameters, bleeding, wound healing and requirement for rescue medication was also studied. Peak pain scores were observed approximately 5– 6 hours after the operation. Betamethasone showed significant analgesic activity from day 1. Ibuprofen andbetamethasone were significantly more effective than placebo in reducing swelling. Trismus was least with betamethasone. A significant rise in temperature on the operated side occurred only on day 1 in all the groups. Serratiopeptidase did not showed significant analgesic and anti-inflammatory action. Mild-to-moderate adverse effects were reported.

D. Chopra1, H. S. Rehan1, P. Mehra2, A. K. Kakkar1
1Department of Pharmacology, Lady Hardinge Medical College, New Delhi, India; 2 Department of Dental and Oral Surgery, Lady Hardinge Medical College, New Delhi, India

Keywords: analgesic; pain; swelling; impacted third molar; postoperative sequelae. Accepted for publication 16 December 2008 Available online 24 January 2009

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# 2008 International Association of Oraland Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Drugs and postsurgical oral pain.
Impaction of the third molar is a common disorder, which often necessitates tooth removal. The common postoperative sequelae of surgical removal of impacted teeth are pain, trismus and swelling, related to the local inflammatory reaction, with cyclooxygenase (COX) and prostaglandinsplaying a crucial role23. Good surgical technique and gentle tissue handling minimize postoperative inflammation but do not prevent it6. Before the development of non-steroidal anti-inflammatory drugs (NSAIDs), opioids were relied on for pain relief. Opioid drugs are effective analgesics, but because they do not have anti-inflammatory action their efficacy in dental pain is doubtful. NSAIDs are effectivein the management of postoperative dental pain. The likely mechanism of action is blockade of prostaglandin synthesis. One of the commonly used agents for dental pain is ibuprofen. The efficacy of ibuprofen in the treatment of postoperative dental pain has been evaluated in several clinical trials. Paracetamol is another commonly used non-narcotic analgesic that has been evaluated in postoperativedental pain. The mechanism of its action is unclear. Current evidence from animal and human studies supports the hypothesis that the analgesic effect of paracetamol is central, as a result of the activation of descending serotonergic pathways, but its primary site of action is inhibition of prostaglandin synthesis. Biochemical studies suggest COX-3 activity that is selectively susceptible to...