Comparative Efficacy of 4 Oral Analgesics

Study Overview
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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.

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: Oxycodone/acetaminophen (5/325) Hydrocodone/acetaminophen (5/325) Codeine/acetaminophen (30/300) Ibuprofen/acetaminophen (400/1000)

Official Title
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Comparative Efficacy of 4 Oral Analgesics for the Initial Management of Acute Musculoskeletal Extremity Pain

Conditions
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Pain

Intervention / Treatment
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* Drug: Oxycodone/acetaminophen
* Drug: Hydrocodone/acetaminophen
* Drug: Codeine/acetaminophen
* Drug: Ibuprofen/acetaminophen


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxycodone/acetaminophen<br>Oxycodone/acetaminophen (5 mg/325 mg) | Drug: Oxycodone/acetaminophen<br> <br> * Other names: Percocet;|
| Active Comparator: Hydrocodone/acetaminophen<br>Hydrocodone/acetaminophen (5 mg/300 mg) | Drug: Hydrocodone/acetaminophen<br> <br> * Other names: Norco;|
| Active Comparator: Codeine/acetaminophen<br>Codeine/acetaminophen (30 mg/300 mg) | Drug: Codeine/acetaminophen<br> <br> * Other names: Tylenol with codeine;|
| Active Comparator: Ibuprofen/acetaminophen<br>Ibuprofen/acetaminophen (400 mg/1000 mg) | Drug: Ibuprofen/acetaminophen<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible) | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores | Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible) | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain