Comparing Five Oral Analgesics for Treatment of Acute Pain in the ED

The optimal treatment of musculoskeletal extremity pain in the ED not known. The study is a
randomized controlled trial designed to compare the efficacy of five oral analgesics: 5 mg
oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine +
300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000
mg acetaminophen for the treatment of patients with acute musculoskeletal pain. The primary
outcome is the between treatment group difference in change in patients' rating of pain
intensity one hour after ingestion of the study medication. Secondary outcomes include: 1)
the between treatment group difference in change in patients' rating of pain intensity two
hours after ingestion of the study medication; 2) difference in proportion of patients who
receive rescue medication; 3) difference in proportion of patients who would choose to take
the study medication again if they returned to the ED with similar pain; 4) difference in
proportion of patients who experience side effects.

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 HCG 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, ritanovir, terbinafine, or St John's Wort