Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED)
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Emergencies
Intervention: oxycodone/APAP; hydrocodone/APAP; codeine/APAP; 400 ibuprofen/APAP; 800 ibuprofen/APAP
Intervention description: Oxycodone/acetaminophen 5 mg-325 mg oral tablet; Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet; Codeine/acetaminophen 30 mg-300mg oral tablet; ibuprofen/acetaminophen 400 mg-1000mg oral tablet; ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
Intervention MeSH terms: Acetaminophen; Ibuprofen; Oxycodone; Hydrocodone; Codeine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: A pharmacist working in an area inaccessible to ED staff will ensure blinding of the study by masking the medication and inserting it into identical unmarked gel capsules, filling any void with small amounts of lactose. Randomization will be performed in blocks of 10 determined by a sequence generated at http://www.randomization.com. The pharmacist will make up numbered research packets based on the random allocation list, each with 5 tablets containing the masked investigational medication. Research packets will be removed sequentially by the nurse from the Pyxis automated medical dispensing system and administered to the study patients in the ED.
Enrollment: 600.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: acute pain; musculoskeletal pain; emergency medicine; Emergency Service, Hospital; analgesics; Acetaminophen; Ibuprofen; oxycodone; hydrocodone; codeine; adult

Summary:

      This study compares 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 who present to the Emergency
      Department (ED).
    

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