Status:
UNKNOWN
Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries
Lead Sponsor:
Children's Hospitals and Clinics of Minnesota
Conditions:
Pain, Muscle
Pain, Acute
Eligibility:
All Genders
11-18 years
Phase:
PHASE2
PHASE3
Brief Summary
In the Emergency Department, there is no standard of care for pain medication distribution for children with an acute musculoskeletal injury when there is no fracture present. Currently, ibuprofen is ...
Eligibility Criteria
Inclusion
- Patient presents to the Emergency Department with an acute, soft tissue ankle or forearm injury
- ED Provider orders an X-ray for evaluation of injury
- Patient's initial pain score is of a 4 or higher
- Patient has noticeable swelling at the site of the injury
Exclusion
- Patient is diagnosed with a fracture
- Patient has an allergy to ibuprofen
- Patient is already on a NSAID, acetaminophen, anticoagulant or oral corticosteroid therapy for chronic pain treatment (a NSAID given in triage or use for the current injury is allowed)
- Use of other concurrent complementary medicine therapy, e.g. massage, acupuncture, physical therapy
- Patient has been treated for this injury in the past
- Patient has a bleeding/bruising disorder
- Patient is pregnant or is lactating
- Patient has a liver or kidney disease, malignancy, infection, immunodeficiency or metabolic syndrome
- Patient is allergic to the Asteraceae family of plants (arnica, ragweed, chrysanthemum, marigold, or daisy are the most common)
- Patient is nonverbal, and thus unable to give a pain score
- Patient does not have a working telephone (required for follow-up call)
- Family requires foreign language interpreter during their ED visit
Key Trial Info
Start Date :
July 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT05283434
Start Date
July 15 2021
End Date
June 30 2023
Last Update
March 17 2022
Active Locations (2)
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1
Children's Minnesota
Minneapolis, Minnesota, United States, 55404
2
Children's Minnesota
Saint Paul, Minnesota, United States, 55102