Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge

Completed · Phase 3

Conditions studied: Analgesia After ED Discharge for Extremity Injuries

In brief

There will be 3 randomized, double-blinded clinical trials to help determine which of commonly prescribed oral opioid combination is most effective in managing acute extremity pain after discharge from the adult emergency department. The first trial compares hydrocodone 5mg / acetaminophen 500mg to codeine 30mg/acetaminophen 300mg. The second trial compares oxycodone 5mg/acetaminophen 325mg to codeine 30mg/acetaminophen 300mg. The third trial compares oxycodone 5mg/acetaminophen 325 mg to hydrocodone 5mg/acetaminophen 325 mg.

Key facts

Study ID

NCT01402375

Run by

Montefiore Medical Center

People needed

720

Starts

2012-01-01

Expected to finish

2014-11-01

Last updated by the study team

2018-05-01

Who can join

Age: 21 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patient has complaint of acute extremity pain (less than 7 days duration)
• clinician plans to discharge on oral pain medication

You may not qualify if…

• patients on methadone
• chronic pain condition such as sickle cell anemia or fibromyalgia
• history of adverse reaction to one of the study medications
• taken prescribed opioids in the past 24 hrs
• have a medical condition that might alter the metabolism of one of the study medications (i.e. hepatitis, renal insufficiency, thyroid disease, Adrenal disease)
• Take a medication that might interact with one of the study medications

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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