title: 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).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Etodolac can be considered as an effective alternative to traditional NSAIDS in the treatment of post operative pain.
authors.affiliation: Ipca Laboratories Limited, Mumbai, India. anilpareek@ipca.co.in
authors.forename: Anil
authors.initials: A
authors.lastname: Pareek
authors.forename: Nitin
authors.initials: N
authors.lastname: Chandurkar
authors.forename: Anil
authors.initials: A
authors.lastname: Gupta
authors.forename: Yatin
authors.initials: Y
authors.lastname: Desai
authors.forename: Hiranya
authors.initials: H
authors.lastname: Kumar S
authors.forename: Amit
authors.initials: A
authors.lastname: Swamy
authors.forename: Ashish
authors.initials: A
authors.lastname: Sirsikar
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D004008:Diclofenac / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D017308:Etodolac / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D009985:Orthopedics; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D016861:Cyclooxygenase Inhibitors; D004008:Diclofenac; D017308:Etodolac