Health Condition 1: null- Post Operative Orthopedic pain
Conditions
Interventions
Intervention1: Etodolac: 400mg injection (IM)
Control Intervention1: Diclofenac: 75mg Injection (IM)
Sponsors
Ipca Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18 to 65 years 2. Satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition 3. Patients who are undergoing any of the following elective orthopedic surgeries such asknee arthroscopy, repair of femoral neck fracture, repair of trochanteric fracture, repair of ankle fracture (bimalleolar type), repair of femoral or tibial fracture, fixation for foot injuries, fixation for pelvic fractures and repair of patella fracture. 4.Patients with the post operative orthopedic pain of at least 5cm on the 10cm pain intensity Visual Analogue Scale and at least a score of 2 on 4 point verbal rating scale 5. Patients fulfilling the American Society of Anesthesiology (ASA) I or II or III criteria for post operative orthopedic pain 6. The subject must understand and be able, willing and likely to fully comply with study procedures and ready to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients having complication during or after surgical procedure 2. Patients with abnormal renal and liver function 3. Patients with significant medical illness 4. Patient having any concomitant medication, which may interact with action of study drugs. 5. Patients with known history of hypersensitivity to NSAIDS or diclofenac or any other ingredient of the study medication or other similar drugs of same chemical class 7. Pregnant or lactating women 8. Women of childbearing potential not practicing contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean fall in pain intensityTimepoint: At 15 min, 30 min, 1 hr and then 2, 4, 6, 8, 12, 16, 20 and 24 hours;Mean fall in pain intensityTimepoint: At 15 min, 30 min, 1 hr and then 2, 4, 6, 8, 12, 16, 20 and 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and toleability of study medicationTimepoint: throughout the duration of study;Total doses of rescue medication consumedTimepoint: In the entire study duration | — |
Countries
India
Contacts
Public ContactNitin Chandurkar
Ipca Laboratories Limited
Outcome results
None listed