traumatic amputation
Conditions
Interventions
Intervention group:oral oxycodone (10 mg) and acetaminophen (650 mg)
Control group:acetaminophen (650 mg) only
Sponsors
Shanghai Jiaotong University Affiliated Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 100 years, male or female is not limited; 2. Diagnosis of acute limb fracture less than one day after injury; 3. Location of fractures including foot, ankle, tibia, fibula, knee, femur, hip, hand, wrist, forearm, elbow, humerus, shoulder and clavicle; 4. Indicated for nonoperative treatment; 5. And willing to participated in this study.
Exclusion criteria
Exclusion criteria: 1. Patients with non-limb fractures; 2. Patients who have multiple fractures involving more than one site; Patients patients with vascular, nerve, or tendon injuries; 3. Open fractures; 4. Patients with a pre-injury chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy; 5. Patients who have taken methadone at any time in their life; 6. Patients who report any adverse reaction; 7. Patients who are allergic to any of the study medications; Patients who have contraindications, such as peptic ulcer disease, or who report any prior use of recreational narcotics; 8. Medical conditions that might affect metabolism of opioid analgesics or acetaminophen, such as hepatitis, renal insufficiency or failure, hypo- or hyperthyroidism, and Addisons or Cushings disease; 9. Taking any medicine that might interact with any of the study medications, such as anticholinergic drugs, oral contraceptives, loop diuretics, probenecid, or liver enzyme inducers; 10. Unable to communicate properly and answer questions (e.g., patients with a diagnosis of dementia); 11. Physically handicapped people with mobility problems; 12. People with no fixed domicile and short-term visitors who cannot be easily located; 13. Patients who are pregnant, verified by urine or serum HCG testing; 14. People unwilling or unable to cooperate with data collectors or researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| SAS score;SDS score;EQ-5d;the patient’s satisfaction with the medication (0-10);change in the quality and duration of sleep;number of study medications used;duration that analgesics were taken;adverse events; | — |
Countries
China
Contacts
Public ContactXianyou Zheng
Shanghai Jiaotong University Affiliated Sixth People's Hospital
Outcome results
None listed