A clinical trial to study the effects of flupirtine maleate as compared to ibuprofen on pain relief in gynaecological day care surgeries.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Females 18-70 years Gynecological ambulatory surgeries ranging up to 60 minutesHealth Condition 2: N958- Other specified menopausal and perimenopausal disorders
- Registration Number
- CTRI/2013/02/003392
- Lead Sponsor
- Department of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
18-70 years
Body Mass Index 25-30 kg/m2
Gynecological ambulatory surgeries ranging up to 60 minutes
American Society of Anaesthesiologist I-II
Exclusion Criteria
History of intake of any analgesics in past three days
Known hypersensitivity to any of the drug under study
Hepatic insufficiency
Patient with impaired renal function
Gastritis
Coagulopathy
Previous cerebral vascular accident history
History of uncontrolled cardiopulmonary disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Verbal categorical rating Pain scaleTimepoint: At 0, 2,4,6,8,12,24,48 hours after surgery (0 hour being the time of admission to post anaesthesia care unit(PACU) when the first pain measurement will be taken).
- Secondary Outcome Measures
Name Time Method Effect of flupirtine maleate versus ibuprofen on patient sedation score patient satisfaction score requirement of rescue analgesics and any adverse effectsTimepoint: one year