Pain Clinical Trial
Official title:
A Study Comparing Recurrent Use of Morphine Sulfate Immediate Release, Oxycodone/Acetaminophen (Percocet), and Hydrocodone/Acetaminophen (Vicodin) at Discharge From the ED in Opioid-naïve Adult Patients With Moderate to Severe Pain.
This is a prospective randomized, clinical trial comparing recurrent use of Morphine Sulfate Immediate Release (MSIR), Oxycodone/Acetaminophen (Percocet), and Hydrocodone/Acetaminophen (Vicodin) at discharge from the emergency department for opioid-naive adult patients presenting with moderate-to-severe pain. At discharge, patients will be randomized to receive either 5 mg of Oxycodone/Acetaminophen (Percocet) tablet 4 times a day for 5 days, 5 mg of Hydrocodone/Acetaminophen (Vicodin) tablet 4 times a day for 5 days, or 15 mg Morphine Sulfate Immediate Release (MSIR) tablet 4 times a day for 5 days. At 1 month, 3 months, and 6 months patients' prescription's history will be accessed by using the DoctorFirst Drug Database to determine the recurrent use that will serve as a surrogate marker of likeability and abuse liability of each prescribed opioid.
Purpose:
The purpose of this study is to evaluate and compare rates of recurrent use (surrogate for
abuse liability and likeability) of Morphine Sulfate Immediate Release,
Oxycodone/Acetaminophen (Percocet), and Hydrocodone/Acetaminophen (Vicodin) at discharge from
the ED (by comparing a percentage of patients in each group at 1 month, 3 months and 6 months
that are still using the same opioid analgesics for presumably non-medical use.
Objective and Hypothesis:
The outcome of the study is to evaluate and compare the rates of recurrent use of prescribed
opioids at discharge from the ED by comparing a percentage of patients in each group at 1
month, 3 months and 6 months that are still using the same opioid analgesics for presumably
non-medical use that will be used as a surrogate for comparison of abuse liability and
likeability. Our goal is to prove that MSIR will have the lowest recurrent use rates at
specified time periods than Percocet and Vicodin and that MSIR should be considered as the
opioid of choice at discharge from the ED. Our hypothesis is that MSIR is associated with
lower number of patients with recurrent use at specified time periods than Percocet and
Vicodin due to the lesser abuse liability and likeability.
Methodology:
This is a prospective randomized, clinical trial comparing recurrent use of Morphine Sulfate
Immediate Release (MSIR), Oxycodone/Acetaminophen (Percocet), and Hydrocodone/Acetaminophen
(Vicodin) at discharge from the ED for opioid-naive adult patients presenting with
moderate-to-severe pain. At discharge, patients will be randomized to receive either 5 mg of
Oxycodone/Acetaminophen (Percocet) tablet 4 times a day for 5 days, 5 mg of
Hydrocodone/Acetaminophen (Vicodin) tablet 4 times a day for 5 days, or 15 mg Morphine
Sulfate Immediate Release (MSIR) tablet 4 times a day for 5 days. At 1 month, 3 months, and 6
months patients' prescription's history will be accessed by using the DoctorFirst Drug
Database to determine the recurrent use that will serve as a surrogate marker of likeability
and abuse liability of each prescribed opioid.
Statistical Analyses:
The nominal variables will be presented as percentages with confidence intervals (CIs), and
continuous variables will be presented as means with SDs, or medians with interquartile
ranges when appropriate. The odds ratios of recurrent use will be compared with logistic
regression to adjust for age, sex, race, chief complaint, and opioid prescription filling. In
addition, to test for proportional difference with respect to recurrent opioid use, we will
use a Pearson Chi-square test.
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