To determine the efficacy and safety of Inj Diclofenac 75mg/ml given intradeltoid with Injection Diclofenac 75mg/3ml given intragluteal in the management of postoperative pain in obese patients.
- Conditions
- Health Condition 1: null- Post Operative Pain
- Registration Number
- CTRI/2009/091/000108
- Lead Sponsor
- Troikaa Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Patients in the age group of 18 to 65 years
Patients of both sexes
Patients with BMI greater or equal to 25
Patients undergoing operative procedures requiring hospitalization for at least 48 hours
Patients with moderate to severe pain at baseline VAS 4 to10
1.Patients below 18 years and above 65 years of age
2.Patients with BMI < or = 25
3.OPD patients/ patients requiring hospitalization less than 48 hours
4.Patients with compromised renal function
5.Pregnant and lactating women
6.Patients with history of bronchial asthma, peptic ulceration, bronchitis
7.Patients with coagulation disorders, especially bleeding disorders
8.Mentally retarded patients
9.Unwilling patients
10.Patients with known hypersensitivity to propylene glycol, diclofenac sodium any other NSAIDs or any component of either of the study formulations
11.Patients with a baseline VAS score of 3 or less than 3
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Degree of pain relief, as assessed by a 5- point scale by patientsTimepoint: At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.;Degree of pain relief, as assessed by a 5- point scale by patientsTimepoint: At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.;Degree of pain relief, as assessed by a 5- point scale by patientsTimepoint: 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<br>;Systemic Adverse Reactions and Rescue MedicationTimepoint: Upto 48 hours.