Clinical Study of efficacy & safety of dexketoprofen injection compared to diclofenac injection in post-operative pai

Phase 3

Completed

• Registration Number: CTRI/2009/091/000388
• Lead Sponsor: Emcure Pharmaceuticals Ltd. Pune

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male or female patients between 18- 65 years of age.
2. Patients undergoing surgery for (Inguinal/Incisional/Umbilical/Congenital/Other) hernia repair
3. Willing to give written informed consent and willing to comply with the trial protocol.
4. Patients with normal baseline laboratory parameters.

Exclusion Criteria

1. Patients with known hypersensitivity to the study medications and /or history of any drug allergy or intolerance to NSAIDs or any anesthetic medication.
2. Complication during or after surgical procedure.
3. Patients on any anti-inflammatory or other therapy known to affect the study outcome.
4. Patients with active or suspected gastrointestinal ulcer / history of gastrointestinal ulcer / chronic dyspepsia or gastrointestinal bleeding.
5. Patients with Crohn?s disease or ulcerative colitis
6. Patients with history of bronchial asthma
7. Patients with severe heart failure / moderate to severe renal dysfunction (Creatinine clearance < 50 ml/min) or severely impaired hepatic function (Child- Pugh score 10- 15)
8. Patients with hemorrhagic diathesis and other coagulation disorders
9. Any contraindication to use of NSAID.
10. Drug addiction or alcoholism.
11. Women who are pregnant, lactating, of child bearing potential who are not practicing effective methods of contraception.
12. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
13. Current participation or participation within the previous three months in other clinical trials.

Study & Design

• Study Type: Interventional
• Study Design: Not specified