Comparison of two pain management regimens in cases of mutiple extremity fractures
Phase 4
- Conditions
- Health Condition 1: T07- Unspecified multiple injuries
- Registration Number
- CTRI/2020/09/027666
- Lead Sponsor
- udhiana Mediways
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All adult patients (aged >= 18 years) with periarticular or multiple shaft fractures who underwent operation will be eligible for enrollment in the study.
Exclusion Criteria
The patients with pathological fracture, Pregnant females, Breast feeding females ,Substantial injury outside the skeletal system like head injury, chest or abdomen injury requiring operative intervention, liver or renal dysfunction, pelvic or spine injuries, Fracture of small bones like clavicle, hand or foot, subjects who require additional opioid or other pain relieving medication after two days in hospital stay will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The aim of this study is to assess the satisfaction with pain relief in cases recovering from periarticular or multiple extremity fractures treated operatively who will be randomized to receive either combination of acetaminophen nefopam and tramadol (Group A)or acetaminophen and tramadol (Group B) . The primary objective of the study will be to ascertain noninferority in pain relief of drug combination of acetaminophen with nefopam to that of acetaminophen with tramadol.Timepoint: 24 hours, two weeks
- Secondary Outcome Measures
Name Time Method The aim of this study is to assess the satisfaction with pain relief in cases recovering from periarticular or multiple extremity fractures treated operatively who will be randomized to receive either combination of acetaminophen nefopam and tramadol (Group A)or acetaminophen and tramadol (Group B) . The primary objective of the study will be to ascertain noninferority in pain relief of drug combination of acetaminophen with nefopam to that of acetaminophen with tramadol.Timepoint: 24 hours, two weeks