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 pain

A Randomized, Parallel Group, Comparative Study Evaluating the Efficacy and Tolerability of Injection Diclofenac Sodium 75mg/1mL given as an IV Injection versus Diclofenac Sodium 75mg/3mL given as an Infusion in the management of Post Operative Pain.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000096

Enrollment

250

Registered

2010-03-05

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

Health Condition 1: null- Post Operative Pain

Interventions

Intervention1: Injection diclofenac sodium 75 mg/ 1 ml (Mfg. by Troikaa Pharmaceuticals Ltd.): 75mg to be injected intravenously as IV bolus over a period of 5- 60 seconds. Control Intervention1: Inje

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
1. Time to onset of analgesia 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. 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 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. 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.	—

Measure

Time frame

1. Time to onset of analgesia 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. 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 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. 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.

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

India

Contacts

Public ContactDr sanjay maroo

Troikaa Pharmaceuticals Limited

sanjaymaroo@troikaapharma.com07926856242

Outcome results

None listed

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