Last updated: March 7, 2022
Sponsor: Children's Hospitals and Clinics of Minnesota
Overall Status: Active - Recruiting
Phase
2/3
Condition
Acute Pain
Pain
Muscle Pain
Treatment
N/AClinical Study ID
NCT05283434
1812-139
Ages 11-18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient presents to the Emergency Department with an acute, soft tissue ankle orforearm 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
Exclusion Criteria:
- Patient is diagnosed with a fracture
- Patient has an allergy to ibuprofen
- Patient is already on a NSAID, acetaminophen, anticoagulant or oral corticosteroidtherapy for chronic pain treatment (a NSAID given in triage or use for the currentinjury 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 ormetabolic 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
Study Design
Total Participants: 324
Study Start date:
July 15, 2021
Estimated Completion Date:
June 30, 2023
Connect with a study center
Children's Minnesota
Minneapolis, Minnesota 55404
United StatesActive - Recruiting
Children's Minnesota
Saint Paul, Minnesota 55102
United StatesActive - Recruiting
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