Pain, Acute Clinical Trial
Official title:
Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries
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 a favorable choice for the treatment, but studies have shown concern for delayed healing activity associated with NSAIDs like Ibuprofen. Homeopathic Arnica Montana is a well-established complimentary medicine and may provide a good alternative for managing acute pain from musculoskeletal injuries, especially in children, given the palatability and rarity of side effects. This study aims to compare usual care vs. usual care plus Arnica 1M* (oral) or the placebo for management of pain in acute musculoskeletal extremity injuries without fracture by utilizing a double-blind clinical trial design. The primary outcome is to determine if subjects use less ibuprofen when given Arnica 1M.
Status | Recruiting |
Enrollment | 324 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 11 Years to 18 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Minnesota | Minneapolis | Minnesota |
United States | Children's Minnesota | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Children's Hospitals and Clinics of Minnesota |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Routine Change | The number of days the family's usual routine has been changed or disrupted following discharge | Three full days after discharge | |
Other | Days of School/Work family members missed | The number of days of school and/or work days the patient's family missed after discharge | Three full days after discharge | |
Other | Days of School/Activities that a patient has missed | The number of days of school and/or activities the patient missed after discharge | Three full days after discharge | |
Primary | Ibuprofen Dose | Amount of Ibuprofen the patient consumed during the three full days after discharge | Initial Emergency Department Visit to three full days after discharge | |
Secondary | Swelling | Swelling Measurement (cm) | Initial Emergency Department Visit to three full days after discharge | |
Secondary | Pain Score | Patient's Pain Score on a 1-10 scale where 1 is the lowest | Initial Emergency Department Visit to three full days after discharge | |
Secondary | Arnica Dosage | The amount of Arnica doses (e.g., 2 pills) that were consumed; ranging from 1 to 4. | Within the first 24 hours of discharge |
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