Comparative Efficacy of 4 Oral Analgesics

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Hydrocodone/acetaminophen; Drug: Codeine/acetaminophen; Drug: Oxycodone/acetaminophen; Drug: Ibuprofen/acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT02455518

2014-4156

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 416 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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416 participants in 4 patient groups

Oxycodone/acetaminophen

Active Comparator group

Description:

Oxycodone/acetaminophen (5 mg/325 mg)

Treatment:

Drug: Oxycodone/acetaminophen

Hydrocodone/acetaminophen

Active Comparator group

Description:

Hydrocodone/acetaminophen (5 mg/300 mg)

Treatment:

Drug: Hydrocodone/acetaminophen

Codeine/acetaminophen

Active Comparator group

Description:

Codeine/acetaminophen (30 mg/300 mg)

Treatment:

Drug: Codeine/acetaminophen

Ibuprofen/acetaminophen

Active Comparator group

Description:

Ibuprofen/acetaminophen (400 mg/1000 mg)

Treatment:

Drug: Ibuprofen/acetaminophen