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Analgesia After ED Discharge for Extremity Injuries | Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge

Analgesia After ED Discharge for Extremity Injuries research study

What is the primary objective of this study?

There will be 2 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 while the second trial compares oxycodone 5mg/acetaminophen 325mg to codeine 30mg/acetaminophen 300mg.

Who is eligible to participate?

Inclusion Criteria: - patient has complaint of acute extremity pain (less than 7 days duration) - clinician plans to discharge on oral pain medication Exclusion Criteria: - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Analgesia After ED Discharge for Extremity Injuries

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Oral Opioid Pain MedicineIn the first trial, patients will take 1 dose of either Hydrocodone or Codeine combined with Acetaminophen every 4 hours as needed for pain. In the second trial, patients will take 1 dose of either oxycodone or Codeine combined with Acetaminophen every 4 hours as needed for pain.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

HydrocodoneHydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

CodeineCodeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

OxycodoneOxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Codeine (for second trial)Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Study Status

Completed

Start Date: January 2012

Completed Date: January 2014

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Difference in pain score before and after last dose.

Secondary Outcome: Overall Satisfaction with the pain medicine

Study sponsors, principal investigator, and references

Principal Investigator: Andrew Chang, MD

Lead Sponsor: Montefiore Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01402375

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