Bronx, New York 10467


Purpose:

The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED.


Study summary:

To perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED. The 4 groups are as follows: 1. Oxycodone/acetaminophen (5/325) 2. Hydrocodone/acetaminophen (5/325) 3. Codeine/acetaminophen (30/300) 4. Ibuprofen/acetaminophen (400/1000)


Criteria:

Inclusion Criteria: - Complaint of acute pain of < 7 days duration - Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities; - Radiologic evaluation is planned Exclusion Criteria: - Inability to confirm reliable means of phone followup. - Past use of methadone - Chronic condition requiring frequent pain management such as 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 8 hours - Pregnancy by either urine or serum HCG testing - Breastfeeding per patient report - History of peptic ulcer disease - Report of any prior use of recreational narcotics - 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 - 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.


NCT ID:

NCT02455518


Primary Contact:

Andrew Chang, MD
Phone: 718-920-2606
Email: achang3@yahoo.com


Backup Contact:

N/A


Location Contact:

Bronx, New York 10467
United States

Andrew Chang, MD
Phone: 718-920-6626
Email: achang3@yahoo.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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