Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT03173456
Eligibility Criteria:
Inclusion Criteria:
* Patients ages 21 through 64 years of age
* Complaint of acute musculoskeletal pain in one or more extremity, defined as distal to and including the shoulder or hip joints.
* Pain of less than seven days duration
* Patient speaks Spanish or English
* The clinician plans to treat the patient in the ED with oral analgesics and is willing to treat the patient with opioid analgesics or up to 800 mg ibuprofen and 1000 mg acetaminophen
* Patient is going to receive imaging of the painful extremity
* Clinician judges patient to have capacity to provide informed consent
Exclusion Criteria:
* Patient does not have cell phone or cannot receive a verification phone call on their cell phone while in the ED
* Any use of methadone currently or previously
* Chronic condition requiring frequent pain management such as arthritis, sickle cell disease, fibromyalgia, or any neuropathy
* History of an adverse reaction to any of the study medications
* Opioids taken in the past 24 hours
* Ibuprofen or acetaminophen taken in past 24 hours
* Any other prescribed or over the counter topical or oral analgesics taken in past 24 hrs
* Pregnancy by either urine or serum human chorionic gonadotropin testing
* Breastfeeding per patient report
* History of peptic ulcer disease
* Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's, or Cushing's disease
* Lacerations,
* Multiple injuries
* Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritonavir, terbinafine, or St John's Wort
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
64 Years
Study:
NCT03173456
Study Brief:
Protocol Section:
NCT03173456