Copyright © 2011 Informa UK Limited Not for Sale or Commercial Distribution Unauthorized use prohibited. Authorised users can download, display, view and print a single copy for personal use Current Medical Research & Opinion Vol. 27, No. 11, 2011, 1–9 0300-7995 Article ST-0252.R1/619179 doi:10.1185/03007995.2011.619179 All rights reserved: reproduction in whole or part not permitted Original article Comparative evaluation of efficacy and safety of etodolac and diclofenac sodium injection in patients with postoperative orthopedic pain Anil Pareek Nitin Chandurkar Ipca Laboratories Limited, Mumbai, India Anil Gupta Mahatma Gandhi Medical College & Hospital, Sitapura, Jaipur, India Yatin Desai Sheth Vadilal Sarabhai General Hospital, Ellis Bridge, Ahmedabad, India Hiranya Kumar S. Vydehi Institute of Medical Sciences & Research Center, Whitefield, Bangalore, India Amit Swamy Padmashree Dr DY Patil Medical College, Sant Tukaram Nagar, Pimpri, Pune, India Ashish Sirsikar GR Medical College & JA Group of Hospitals, Gwalior, India Author for correspondence: Anil Pareek, MD, President, Medical Affairs and Clinical Research, Ipca Laboratories Limited, 142 AB, Kandivli Industrial Estate, Kandivli (West), Mumbai 400067, India. Tel.: þ91 22 66474641; Fax: þ91 22 28686954; anilpareek@ipca.co.in Key words: Diclofenac – Etodolac – Nonsteroidal anti- inflammatory drugs – Postoperative orthopedic pain Accepted: 29 August 2011; published online: 23 September 2011 Citation: Curr Med Res Opin 2011; 27:1–9 Abstract Objective: The objective of this study was to compare the analgesic efficacy of etodolac injection and diclofenac injection in patients with postoperative orthopedic pain. Methods: This was multicentric, randomized, assessor-blind and parallel-group study. A group of 158 patients with moderate to severe pain following orthopedic surgery were randomly assigned to receive either etodolac 400 mg twice a day (n ¼ 78) or diclofenac 75 mg thrice a day (n ¼ 80). Main outcome measures: The primary efficacy outcome measures were pain intensity difference, sum of pain intensity differences and pain relief whereas secondary efficacy variables included maximum fall in pain intensity, number of doses of study medication consumed, number of patients who required rescue medication and overall response to therapy. Results: Mean pain intensity differences assessed on 10 cm VAS were significantly better for etodolac arm compared to diclofenac arm at 4, 8, 20 and 24 hours ( p50.05). Sum of pain intensity differences over the first 8 hours (21.31  6.26 for etodolac vs. 19.13  6.98 for diclofenac; p ¼ 0.041) and over the 24 hours (39.83  10.70 for etodolac vs. 35.25  12.00 for diclofenac; p ¼ 0.012) for the etodolac group was significantly superior than diclofenac group. Assessment of pain relief showed that etodolac injection was significantly more effective than diclofenac injection ( p50.0001) over the 24 hour assessment period. Maximum fall in pain intensity score, number of doses of study medication consumed and patients’ and investigators’ overall response to the drug at the end of treatment period were also significantly superior in the etodolac arm as compared to the diclofenac arm ( p50.05). However, the number of patients who were rescued was comparable in both the treatment arms. A change in emotional functioning of the patients was not captured in this study. Both the study medications were well tolerated with no incidence of SAE throughout the study. Conclusion: Etodolac can be considered as an effective alternative to traditional NSAIDS in the treatment of post operative pain. Introduction Effective pain relief is extremely important during the postoperative period and this should be achieved for humanitarian reasons. Inadequate pain management can contribute to unnecessary discomfort, increased morbidity, delayed ! 2011 Informa UK Ltd www.cmrojournal.com Etodolac in postoperative orthopedic pain Pareek et al. 1 Curr Med Res Opin Downloaded from informahealthcare.com by 124.247.232.163 on 09/25/11 For personal use only.