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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 21 Years and 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized controlled trial
Primary Purpose
Treatment
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.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
oxycodone/acetaminophen (APAP) 		5 mg oxycodone + 325 mg acetaminophen
  • Drug: oxycodone/APAP
    Oxycodone/acetaminophen 5 mg-325 mg oral tablet
    Other names:
    • Percocet
Active Comparator
hydrocodone/APAP 		5 mg hydrocodone + 300 mg acetaminophen
  • Drug: hydrocodone/APAP
    Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
    Other names:
    • Vicodin
Active Comparator
codeine/APAP 		30 mg codeine + 300 mg acetaminophen
  • Drug: codeine/APAP
    Codeine/acetaminophen 30 mg-300mg oral tablet
    Other names:
    • Tylenol # 3
Active Comparator
400 ibuprofen/APAP 		400 mg ibuprofen + 1000 mg acetaminophen
  • Drug: 400 ibuprofen/APAP
    ibuprofen/acetaminophen 400 mg-1000mg oral tablet
    Other names:
    • Motrin, Tylenol
Active Comparator
800 ibuprofen/APAP 		800 mg ibuprofen + 1000 mg acetaminophen
  • Drug: 800 ibuprofen/APAP
    ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
    Other names:
    • Motrin, Tylenol

More Details

Status
Completed
Sponsor
Albert Einstein College of Medicine

Study Contact

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.