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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000388
Enrollment
Unknown
Registered
2009-06-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: DEXKETOPROFEN INJECTION: Single injection of 50 mg to be given deep intramuscularly Control Intervention1: DICLOFENAC INJECTION: Single injection of 50 mg deep intramuscularly

Sponsors

Emcure Pharmaceuticals Ltd. Pune
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of Injection dexketoprofen trometamol in the treatment of postoperative pain.Timepoint: Baseline, 1, 2, 4, 6 and 8 hours after the injection.—

Secondary

MeasureTime frame
To evaluate the safety of Injection dexketoprofen trometamol in the treatment of postoperative pain.Timepoint: Baseline, 1, 2, 4, 6 and 8 hours after the injection.—

Countries

India

Contacts

Public ContactDR BHAGWAT K GUNALE

EMCURE PHARMACEUTICALS

Bhagwat.Gunale@emcure.co.in02039821000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026