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Clinical Trials/NCT07553000
NCT07553000
Recruiting
Not Applicable

The Additional Pain Relieving Benefit of Using a Splint in Suspected Wrist Fractures in Adult Patients at an Emergency Department - a Randomized Controlled Trial.

Region Skane1 site in 1 country120 target enrollmentStarted: December 14, 2022Last updated:
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ConditionsWrist InjuriesWrist FracturePain, Acute
InterventionsSAM splint

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
120
Locations
1
Primary Endpoint
Pain assessment
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Suspected distal fracture of radius

Exclusion Criteria

  • •No X-ray veriefied fracture.

Arms & Interventions

SAM splint

Active Comparator

Recieves SAM splint for pain relief

Intervention: SAM splint (Device)

Control

No Intervention

Treatment as usual

Outcomes

Primary Outcomes

Pain assessment

Time Frame: 60 minutes

Self assessed pain according to NRS (numeric rating scale)

Secondary Outcomes

  • Negative impact on radiology(24 hours from enrollment in study.)
  • Pain relief medication(24 hours from enrollment.)
  • Adverse events(24 from enrollment in ER.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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