limb fracture
Conditions
Interventions
Control group:Receive oral pills containing oxycodone (5 mg)/acetaminophen (325 mg), as needed
Intervention group:Receive oral pills containing acetaminophen (325 mg) only, as needed
Sponsors
Shanghai Jiaotong University Affiliated Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 100 years old, male or female is not limited; 2. Diagnosis of acute limb fracture less than one day after injury; location of fractures including foot, ankle, tibia, fibula, knee, femur, hip, hand, wrist, forearm, elbow, humerus, shoulder and clavicle; 3. Indicated for nonoperative treatment; 4. Willing to participated in this study.
Exclusion criteria
Exclusion criteria: 1. With other non-limb fractures; multiple fractures involved more than one site; 2. With vascular, nerve or tendon injuries; 3. Open fractures; 4. Chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy; 5. Have taken methadone ever; 6. Report of an adverse reaction to any of the study medications; 7. Allergic to any of the study medications or contraindications such as peptic ulcer disease; 8. Report of any prior use of recreational narcotics; 9. Medical condition that might affect metabolism of opioid analgesics, acetaminophen, such as hepatitis, renal insufficiency or failure, hypo- or hyperthyroidism, Addisons or Cushings disease; 10. Taking any medicine that might interact with any of the study medications, such as anticholinergic drugs, oral contraceptives, loop diuretic, probenecid or liver enzyme inducer; 11. History of mental disorders, unable to communicate properly and answer questions such as dementia etc; 12. Physically handicapped people with mobility problems; No fixed address and easily lost to visitors; 13. Pregnancy by either urine or serum HCG testing; 14. Unwilling or unable to cooperate with data collectors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 11-point Numeric Rating Scale (NRS) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| 11-point Numeric Rating Scale (NRS) score;European Quality of Life 5-Dimensions 5-Levels (EQ-5D-5L) health questionnaire visual analogue scale (EQ-VAS) ;patient-reported overall satisfaction on pain management (on VAS scale, higher scores indicating more satisfaction);Pittsburgh Sleep Quality Index (PSQI);Number of study medications used;Duration that analgesics were taken; | — |
Countries
China
Contacts
Public ContactXianyou Zheng
Shanghai Jiaotong University Affiliated Sixth People's Hospital
Outcome results
None listed