To compare the effectiveness and safety of Inj Diclofenac 75mg/ml given intradeltoid with Injection Diclofenac 75mg/3ml given intragluteal in the management of postoperative pain.
- Conditions
- Health Condition 1: null- Post Operative Pain
- Registration Number
- CTRI/2008/091/000216
- Lead Sponsor
- Troikaa Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
1.Patients in the age group of 18-65 years
2.Patients of both sexes
3.Patients with healthy deltoid/ gluteal muscle mass
4.Patients undergoing operative procedures requiring hospitalization for at least 48 hours with moderate to severe pain
5.Patients with moderate to severe pain at baseline (VAS 4 -10)
1.Patients below 18 years and above 65 years of age
2.OPD patients/ patients requiring hospitalization less than 48 hours
3.Patients with compromised renal function
4.Pregnant and lactating women
5.Patients with history of bronchial asthma, peptic ulceration, bronchitis
6.Patients with bleeding disorders
7.Mentally retarded patients
8.Unwilling patients
9.Patients with known hypersensitivity to diclofenac sodium any other NSAIDs or any component of either of the study formulations
10.Patients with mild baseline pain (1-3)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intensity of post operative pain as assessed by visual analogue scale (VAS)Timepoint: At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.;Intensity of post operative pain as assessed by visual analogue scale (VAS)Timepoint: At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.
- Secondary Outcome Measures
Name Time Method Global efficacy by patients and investigator.Timepoint: End of Study (After 48 hrs);Pain at the site of injection as assessed by visual analogue scale (VAS)Timepoint: At 1 hour and 12 hours after each dose.;Physicians evaluation of swelling, redness and induration at the site of injectionTimepoint: After each dose;Systemic Adverse Reactions and Rescue MedicationTimepoint: Upto 48 hours.