Upper Extremity Fractures, Analgesia Post Fracture
Conditions
Keywords
fracture, pediatric, oral morphine, ibuprofen
Brief summary
Children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for the first 24 hours following discharge from the emergency department. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in greater pain relief than ibuprofen.
Interventions
DRUGOral morphine
oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours
DRUGIbuprofen
Ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) for 24 hours following discharge from the emergency department
Sponsors
Naveen Poonai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
Yes
Exclusion criteria
* patients with known hypersensitivity to either ibuprofen or morphine * chronic users of NSAIDS or opioids * fractures requiring operative management * associated injuries requiring analgesia * poor English fluency * pregnancy Inclusion Criteria: * All patients aged 5 to 17 years with a non-operative forearm or distal radius fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Faces Pain scale - revised | 30 minutes post intervention compared to baseline | The primary outcome variable is the pre-post intervention difference in pain scores as measured by self-reported Faces Pain Scale - Revised (FPS-R) for the first 24 hours post-fracture management following the as needed administration of the study drugs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acetaminophen doses | 24 hours | The secondary outcome variable is the number of breakthrough acetaminophen doses required/taken by the participant for the first 24 hours post-fracture management |
Countries
Canada
Outcome results
None listed