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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
324
Patients will be assigned to the placebo (e.g., unmedicated sugar pill) or experimental group (e.g., Arnica 1M pellets) via a randomization chart from that only the research pharmacist will have access to. Subjects assigned to the experimental group will take the recommended doses of Arnica 1M coated sugar pellets (i.e., 2 pills to be taken every 4 waking hours over a 24 hours period), and will track their pain scores, swelling measurements, sleep rate, ibuprofen doses, adverse reactions, further ED visits, and the number of days/activities the patient has missed for 3 days following their enrollment in the study.
Sugar pill placebo
Children's Minnesota
Minneapolis, Minnesota, United States
RECRUITINGChildren's Minnesota
Saint Paul, Minnesota, United States
RECRUITINGIbuprofen Dose
Amount of Ibuprofen the patient consumed during the three full days after discharge
Time frame: Initial Emergency Department Visit to three full days after discharge
Swelling
Swelling Measurement (cm)
Time frame: Initial Emergency Department Visit to three full days after discharge
Pain Score
Patient's Pain Score on a 1-10 scale where 1 is the lowest
Time frame: Initial Emergency Department Visit to three full days after discharge
Arnica Dosage
The amount of Arnica doses (e.g., 2 pills) that were consumed; ranging from 1 to 4.
Time frame: Within the first 24 hours of discharge
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