Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED)

Albert Einstein College of Medicine

Status and phase: Completed; Phase 2

Conditions: Musculoskeletal Pain

Treatments: Drug: codeine/APAP; Drug: hydrocodone/APAP; Drug: 400 ibuprofen/APAP; Drug: oxycodone/APAP; Drug: 800 ibuprofen/APAP

Study type: Interventional

Funder types: Other

Identifiers

NCT03173456

2016-7322

Details and patient eligibility

About

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).

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 21 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 5 patient groups

oxycodone/acetaminophen (APAP)

Active Comparator group

Description:

5 mg oxycodone + 325 mg acetaminophen

Treatment:

Drug: oxycodone/APAP

hydrocodone/APAP

Active Comparator group

Description:

5 mg hydrocodone + 300 mg acetaminophen

Treatment:

Drug: hydrocodone/APAP

codeine/APAP

Active Comparator group

Description:

30 mg codeine + 300 mg acetaminophen

Treatment:

Drug: codeine/APAP

400 ibuprofen/APAP

Active Comparator group

Description:

400 mg ibuprofen + 1000 mg acetaminophen

Treatment:

Drug: 400 ibuprofen/APAP

800 ibuprofen/APAP

Active Comparator group

Description:

800 mg ibuprofen + 1000 mg acetaminophen

Treatment:

Drug: 800 ibuprofen/APAP