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

• Status: Completed
• Trial end date: 2019-11-14
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine, Inc.
• Treatments: Acetaminophen; Analgesics; Codeine; Hydrocodone; Ibuprofen; Oxycodone

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 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