Comparative evaluation of efficacy and safety of etodolac and diclofenac sodium injection in patients with postoperative orthopedic pain

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 = 78) or diclofenac 75 mg thrice a day (n = 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 (p < 0.05). Sum of pain intensity differences over the first 8 hours (−21.31 ± 6.26 for etodolac vs. −19.13 ± 6.98 for diclofenac; p = 0.041) and over the 24 hours (−39.83 ± 10.70 for etodolac vs. −35.25 ± 12.00 for diclofenac; p = 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 (p < 0.0001) 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 (p < 0.05). 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.

Key words::

• Diclofenac
• Etodolac
• Nonsteroidal anti-inflammatory drugs
• Postoperative orthopedic pain

Transparency

Declaration of funding

This study was sponsored by Ipca Laboratories Limited, Mumbai, India.

Declaration of financial/other relationships

A.P. and N.C. have disclosed that they are employed by Ipca Laboratories Ltd, and were involved in the conceptualization, coordination and execution of the study, at all centers. A.G., Y.D., H.K.S., A.P.S., and A.D.S. have disclosed that they did not receive any financial benefits and declare that they have no conflict of interest.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors would like to thank Mr Ravikiran Payghan, Mr Sachin Joshi and Ms Smita Talekar for technical assistance right from the inception of the study, Mr Mukeshkumar Jha for statistical analysis and data management in this study and Mr Prashant Nawal for providing necessary drafting assistance in this manuscript.