Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet)
Condition: Pain Management
Study type: Interventional
Phase: Phase 2

Summary: 
      Oxycodone and Hydrocodone are the most commonly used oral opioid analgesics in the emergency
      department and in outpatient settings. Both medications have a very high potential for abuse
      due to the prominence of the euphoric effect (abuse liability) and relative lack of "bad "or
      "negative" effects (likeability). The highly addictive properties of these medications lead
      to recurrent ED visits for repetitive dosing and prescribing that may lead to abuse, misuse,
      development of dependence and addiction, and, most importantly, death due to overdose. In
      contrast, several research papers demonstrated that administration of MSIR results in similar
      analgesic efficacy to Oxycodone and Hydrocodone but with significantly less euphoric and
      rewarding associated effects. In addition, consumption of large doses of MSIR leads to
      dysphoria, vomiting and sedation ("negative effects"). To the investigators' knowledge, there
      are no randomized controlled trials in the ED that directly compared analgesic efficacy of
      MSIR to Percocet
    

Detailed description: 
      The investigators' hypothesis is that MSIR coupled with acetaminophen will have similar if
      not better analgesic efficacy at 30 minutes and 1 hour than oxycodone coupled with
      acetaminophen for acute painful conditions in the emergency department.

      This study will be a double-blind randomized clinical trial evaluation analgesic efficacy of
      orally administered MISIR+acetaminophen in comparison to Oxycodone+acetaminophen for treating
      pain. Patients will be enrolled from a single ED in a tertiary academic center.

      Patients based on inclusion criteria will be randomized to receive either 1 tablet of 15mg PO
      morphine sulfate immediate release combined with 650mg of Acetaminophen or 1 tablet 10mg
      Oxycodone combined with 650 mg Acetaminophen. All drugs will be crushed and given to the
      subjects in blinded fashion. Patients, physicians, nurses and research assistants will be
      blinded to drug assignment throughout the study. Medication will be prepared by on site
      pharmacist.

      Pain will be reassessed at both 30 minutes, 45 minutes and 1 hour with the primary outcome of
      reduction in pain score by 1.3 points at 60 minutes. Assuming a 1.7 pain difference is
      minimally significant clinically with standard deviation of 3.0 (based on a previous study of
      morphine analgesia), a minimum of 50 patients per group will be needed for 80% power with
      alpha equal to 0.05.

      Secondary outcomes will include any reported adverse effects; the requirement of additional
      analgesia.

      Generalized likability and chance of repeated use will be reported by using a visual analogue
      scale with following questions:

      "Do you feel any DRUG EFFECT?" "Do you LIKE the drug?" "How HIGH are you?" "Does the drug
      have any GOOD EFFECTS?" "Does the drug have any BAD EFFECTS?" "How much do you DESIRE the
      medication?" " Does the drug make you have UNPLEASANT THOUGHTS?" "Does the drug make you have
      UNPLEASANT BODILY SENSATIONS?" "Does the drug make you feel IRRITATED?" "Does the drug make
      it DIFFICULT TO CONCENTRATE?"

      The patients will respond by positioning an arrow along a 100-point line labeled with "not at
      all" at one end and "extremely" at the other.

      Data will be analyzed by intention to treat and will include frequency distributions, and
      Student's T-test to assess a difference in pain scores and vital signs. The chi-square test
      will assess the presence or absence of side effects between the two groups. Statistical
      analyses will be conducted by the research manager and the hospital senior biostatistician
      who will be independent of all data collection.
    

Intervention name(s): Morphine Sulfate; Oxycodone; Acetaminophen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15mg PO morphine sulfate; 10mg Oxycodone; 650 mg Acetaminophen
Intervention MeSH terms: Acetaminophen; Morphine; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment