Comparative Efficacy of 4 Oral Analgesics

Phase 4

Completed

Interventions: Drug: Oxycodone/acetaminophen
Drug: Hydrocodone/acetaminophen
Drug: Codeine/acetaminophen
Drug: Ibuprofen/acetaminophen

Brief Summary: 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: 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)

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Oxycodone/acetaminophen	Oxycodone/acetaminophen	Oxycodone/acetaminophen (5 mg/325 mg)
Hydrocodone/acetaminophen	Hydrocodone/acetaminophen	Hydrocodone/acetaminophen (5 mg/300 mg)
Codeine/acetaminophen	Codeine/acetaminophen	Codeine/acetaminophen (30 mg/300 mg)
Ibuprofen/acetaminophen	Ibuprofen/acetaminophen	Ibuprofen/acetaminophen (400 mg/1000 mg)

Primary Outcome Measures

Name	Time	Method
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores	2 hours	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)

Secondary Outcome Measures

Name	Time	Method
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores	1 hour	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)