Acute lower limb injury. Superficial injury of hip and thigh, Fracture of femur, Dislocation, sprain and strain of joint and ligaments of hip, Injury of muscle and tendon at hip and thigh level, Crushing injury of hip and thigh, Traumatic amputation of hip and thigh, Superficial
Conditions
Interventions
5 milligrams single dose
in intervention group. Intervention 2: Placebo (distilled water)
manufactured in Daroupakhsh
single dose
Intervention 1: Oxycodone hydrochloride
manufactured by SOHA company
in intervention group. Intervention 3: Morphine sulfate
in control group. Intervention 4: Placebo
in control group.
Treatment - Drugs
Sponsors
Vice Chancellor for Research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
14 Years to 90 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: acute lower limb trauma Exclusion criteria: Patients younger than 14 or older than 90 years old, recent use of opioid, advanced liver/respiratory/renal diseases, head trauma, altered mental state, allergy to opioid, pregnancy
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain severity. Timepoint: 0, 30 and 60 minutes after administration of analgesic. Method of measurement: asking patients, using NRS score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects. Timepoint: 0, 30 and 60 minute after administration of analgesic. Method of measurement: asking patient, using questionnaire.;Blood pressure. Timepoint: Zero, 30, and 60 minutes after administration of analgesic. Method of measurement: Checking blood pressure, using appropriate cuff.;Nausea and vomiting. Timepoint: Zero, 30 and 60 minutes after administration of analgesic. Method of measurement: Asking patient, using questionnaire.;Drowsiness. Timepoint: Zero, 30 and 60 minutes after administration of analgesic. Method of measurement: Asking patient, using questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Jalili
Tehran University of Medical Sciences
Outcome results
None listed