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Clinical Trials/CTRI/2008/091/000216
CTRI/2008/091/000216
Completed
Phase 4

A randomised comparative study evaluating the efficacy and tolerability of injection Diclofenac sodium 75mg/1ml given intradeltoid with injection Diclofenac sodium 75mg/3ml given intragluteal in the management of post operative pain.

Troikaa Pharmaceuticals Limited0 sites250 target enrollmentTBD
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ConditionsHealth Condition 1: null- Post Operative Pain

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- Post Operative Pain
Sponsor
Troikaa Pharmaceuticals Limited
Enrollment
250
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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\)

Exclusion Criteria

  • •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\)

Outcomes

Primary Outcomes

Not specified

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