Pain, Acute, Wrist Fracture, Wrist Injuries
Conditions
Brief summary
Randomized clinical trial comparing SAM aluminium splint vs pain relief as usual in patients seeking emergency department care for suspected wrist fractures.
Detailed description
Randomized controlled trial of suspected wrist fractures in patients seeking emergency department care. Comparison of pain relief. Randomized to standard care or standard care + aluminium splint. Primary outcome: Numeric rating scale (NRS) pain rating at 1 hour. Secondary outcomes: Pain medication usage between groups. Negative impact on radiology results. Safety endpoint: Reported side effects
Interventions
DEVICESAM splint
Splint vs no splint in paitents awaiting X-ray in the ER.
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SAM wrist splint
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* NRS 5-10 * Suspected distal fracture of radius
Exclusion criteria
* No X-ray veriefied fracture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | 60 minutes | Self assessed pain according to NRS (numeric rating scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief medication | 24 hours from enrollment. | Between-group comparison of analgesia provided by nursing staff up to 24 hours after presentation at ER. |
| Negative impact on radiology | 24 hours from enrollment in study. | Splint artefacts on radiological exam. |
| Adverse events | 24 from enrollment in ER. | Side effects from splint |
Countries
Sweden
Outcome results
None listed