A Clinical Study to determine the efficacy and safety of Inj Diclofenac 75mg/mL given as an IV injection versus Diclofenac 75mg/3mL given as an IV infusion in the management of postoperative pai

Phase 3

Completed

• Conditions: Health Condition 1: null- Post Operative Pain

• Registration Number: CTRI/2010/091/000096
• Lead Sponsor: Troikaa Pharmaceuticals Limited

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: 250

Inclusion Criteria

1Patients in the age group of 18 to 60 years

2Patients of both sexes

3Patients undergoing elective day surgery with moderate to severe pain

4Patients with moderate to severe pain at baseline (VAS score greater than or equal to 4)

Exclusion Criteria

1. Patients below 18 years and above 60 years of age

2. Patients with compromised renal function

3. Pregnant and lactating women

4. Patients with history of bronchial asthma, peptic ulceration, bronchitis

5. Patients with coagulation disorders (esp. bleeding disorders)

6. Mentally retarded patients

7. Unwilling patients

8. Patients with known hypersensitivity to propylene glycol, diclofenac sodium any other NSAIDs or any component of either of the study formulations

9. Patients with mild baseline pain (VAS < 4)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Time to onset of analgesia <br/ ><br>2. Intensity of Post Operative Pain as assessed by Visual Analogue Scale (VAS)Timepoint: 1. The time to onset of analgesia of the study medication will be assessed and noted after asking and ascertaining from the patient. <br/ ><br> <br/ ><br>2. Intensity of post operative pain would be assessed by visual analogue scale (VAS) assessed by patients at 0 (Basal), 15 minutes, 30 minutes, 45 minutes, 1, 2, 4, 8 and 12 hours.;1. Time to onset of analgesia <br/ ><br>2. Intensity of Post Operative Pain as assessed by Visual Analogue Scale (VAS)Timepoint: 1. The time to onset of analgesia of the study medication will be assessed and noted after asking and ascertaining from the patient. <br/ ><br> <br/ ><br>2. Intensity of post operative pain would be assessed by visual analogue scale (VAS) assessed by patients at 0 (Basal), 15 minutes, 30 minutes, 45 minutes, 1, 2, 4, 8 and 12 hours.

Secondary Outcome Measures

Name	Time	Method
Degree of Pain Relief as assessed on a 5- point Pain Relief Rating ScaleTimepoint: 15 minutes, 1, 4, 8 and 12 Hous After the Dose Given;Global efficacy by Patient and InvestigatorTimepoint: At the End of Study;Pain and Evidence of Thromboplebitis at the site of Injection/ InfusionTimepoint: Upto 12 Hours After the Dose Given;Percentage Pain ReliefTimepoint: 15 minutes After the Dose Given;Systemic Adverse EventsTimepoint: Upto 12 Hours After the Dose Given