long bone fracture. Superficial injury of upper and lower limb
Conditions
Interventions
Intervention 1: Intervention group: Ketorolac. Intervention 2: Control group: Morphine.
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: All patients with long bone (Femur, Tibia, Humorous, Ulnar, Radius) fracture, who need analgesic for pain control
Exclusion criteria
Exclusion criteria: History of substance use disorder (drug addiction)Body weight less than 50 kg, Pregnancy, Breastfeeding, Decreased level of consciousness at the time of presentation, Any evidence of active bleeding, History of hypersensitivity or allergic reaction to ketorolac and/or morphine, History of coagulation disorders or platelet dysfunction, History of peptic ulcer disease, History of liver disease, Presence of fractures involving more than one long bone, Lack of patient cooperation or inability to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain reduction comparison, 2. Assessment of adverse events, 3. Need for additional or rescue medication, 4. Patient satisfaction. Timepoint: 15, 30 and 60 minutes. Method of measurement: Numberings Rating Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve adequate pain relief, Time required for patients to achieve at least a 2-point reduction in NRS pain score. Duration of analgesic effect: Evaluation of how long the analgesic effect of the drug lasts until pain returns to an intolerable level. Follow-up of delayed adverse events: assessment of delayed adverse events up to 48 hours after study drug administration, including gastrointestinal bleeding, liver dysfunction, or other systemic complications. Frequency of additional or rescue medication use within 48 hours: number of times patients in each group require additional doses or rescue analgesics. Secondary clinical safety indicators: changes in blood pressure, heart rate, level of consciousness, and other vital clinical parameters within 6 hours after administration. Timepoint: within 48 hours. Method of measurement: Time to pain relief: Time (minutes) to =2-point reduction in NRS. Duration of drug effect: Time (hours) from pain relief to return of severe pain. Delayed adverse events: Monitoring for up to 48 hours post-drug administration. Need for additional medication: Number of times rescue analgesia is required within 48 hours. Clinical safety indicators: Blood pressure, heart rate, and level of consciousness up to 6 hours post-drug. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Elnaz Vafadar Moradi
Mashhad University of Medical Sciences
Outcome results
None listed