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Comparison of two pain management regimens in cases of mutiple extremity fractures

Pain management with nefopam in operatively treated Periarticular and Multiple extremity fractures : A non-inferiority Randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027666
Enrollment
360
Registered
2020-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: T07- Unspecified multiple injuries

Interventions

Intervention1: Nefopam: Nefopam shall be administered in patients with multiple extremity injuries.After 48 hours of operative procedure, the patients were switched to oral medication for two weeks.

Sponsors

Ludhiana Mediways
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactDeepak Bansal

Ludhiana Mediways

deepakbansal1400@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026