Comparative Efficacy of 4 Oral Analgesics

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-10-04

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No