Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet)

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 1.3 pain difference is
minimally significant clinically with standard deviation of 3.0 (based on a previous study of
morphine analgesia), a minimum of 90 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.

Inclusion Criteria:

- ages 18-64,

- present to the Emergency department with moderate-to-severe acute pain that warrants
an oral opioid analgesic.

- pain score is above 5 and are deemed to require oral opioid at the discretion of the
attending physician.

- Painful conditions will include but will not be limited to acute
traumatic/non-traumatic musculoskeletal pain, renal colic pain, dental pain.

Exclusion Criteria:

- age <18, age >64,

- subjects who received long acting opioids within 24 hours of presenting to ED

- received short acting analgesics within 4 hours,

- chronic pain,

- pregnant patients,

- patient refusal,

- altered mental status,

- known allergy to either morphine or oxycodone or acetaminophen,

- history of substance and opioid abuse,

- unstable vital signs, acute psychosis or incarceration.

- subjects who received long acting opioids within 24 hours of presenting to ED;

- chronic pain"