A clinical trial to assess the efficacy and safety of Injection Dexketoprofen Trometamol in the treatment of Post-operative Pain

Emcure Pharmaceuticals Ltd. Pune0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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.

发起方

Emcure Pharmaceuticals Ltd. Pune