Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge
Condition: Analgesia After ED Discharge for Extremity Injuries
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      Eligible patients are those between the ages of 21 and 64 who present to the Emergency
      Department (ED) with a complaint of acute extremity pain of less than seven days duration in
      one or more extremities and for whom the clinician plans to discharge on an oral opioid for
      pain management. Patients will be excluded if they have ever taken methadone; have a chronic
      condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or
      any neuropathy; report a history of an adverse reaction to any of the study medications; if
      they have taken prescribed opioids in the past 24 hours or if they report having ever taken
      recreational narcotics; if they have a medical condition that might affect their metabolism
      of opioid analgesics or acetaminophen; or if they take any medicine that might interact with
      one of the study medications. Patients will be referred by the attending physician or
      clinician and consent as well as the initial and follow-up data collections will be obtained
      by our team of trained bilingual (Spanish and English) salaried research associates who staff
      the ED 24 hours a day and 7 days a week.

      In the first study, patients will be randomized to one of two experimental groups:
      hydrocodone 5mg / acetaminophen 500mg or codeine 30mg / acetaminophen 300mg. Randomization
      will be performed in blocks of 10 and determined by a sequence generated at
      http://www.randomization.com. The pharmacist working in an area inaccessible to ED staff will
      ensure proper blinding of the study by masking the medication and inserting it into unmarked
      gel capsules and filling any void with small amounts of lactose. A three-day supply (18
      doses) of the blinded medications will be dispensed by the ED staff to the patient in the
      order determined by randomization accompanied by instructions to use one tablet of the
      medication every 4 hours as needed for pain and to avoid use of any other analgesics.

      Using a power of 80%, a significance criterion of 0.5, and an estimated delta of 1.3 NRS
      units, a sample size of 85 patients per group. In order to account for those that do not end
      up taking the medicine, it is estimated that 120 patients per group will have to be enrolled.

      Data will be collected on a standardized data collection instrument, entered by a trained
      data clerk, and reviewed and audited for accuracy and completeness. The investigators will
      calculate descriptive statistics for all variables: frequencies, means and standard
      deviations, medians and IQR, and proportions. Chi-square tests will be used to test
      differences between dichotomous variables, t-tests will be used to test mean differences.
      Multivariate models will be used if there are background variables that are unevenly
      distributed between the two groups. Variables associated with group membership with
      probability of 0.20 or less will be included in OLS multivariate regression or logistic
      regression models in order to test the role of group membership while accounting for chance
      baseline disparities. Interaction terms will be tested and dropped from the models if they
      were not statically significant at the 0.05 level. SPSS version 17 (Chicago, IL.) will be
      used to conduct all data analyses.

      The second trial will be identical to the first trial with the exception of one of the study
      drugs, which will be oxycodone 5mg / acetaminophen 325 mg which will be compared to codeine
      30mg / acetaminophen 300mg.

      The third trial will be identical to the first and second trials with the exception of study
      drugs. This study will use oxycodone 5 mg/acetaminophen 325mg and hydrocodone
      5mg/acetaminophen 325mg.
    

Intervention name(s): Hydrocodone (first trial); Codeine (first trial); Oxycodone (for second trial); Codeine (for second trial); Oxycodone (third trial); Hydrocodone (third trial)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain; Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain; Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain; Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain; Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain; Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.
Other intervention name(s): Vicodin (Hydrocodone 5mg / Acetaminophen 500mg); Tylenol # 3 (Codeine 30 mg/Acetaminophen 300 mg); Percocet (Oxycodone 5mg/Acetaminophen 325 mg); Tylenol # 3 (Codeine 30 mg/Acetaminophen 300 mg); Oxycodone 5mg / Acetaminophen 325 mg; Hydrocodone 5mg / Acetaminophen 325 mg
Intervention MeSH terms: Acetaminophen; Oxycodone; Hydrocodone; Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Pain Management; Emergency Medicine; Extremity Injuries