Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03088826|
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain Management||Drug: Morphine Sulfate Drug: Oxycodone Drug: Acetaminophen||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Analgesic Efficacy of Morphine Sulfate Immediate Release (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet) for Acute Pain in Emergency Department Patients|
|Actual Study Start Date :||August 18, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Active Comparator: MSIR and Acetaminophen Group
The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen
Drug: Morphine Sulfate
15mg PO morphine sulfate
650 mg Acetaminophen
Active Comparator: Oxycodone and Acetaminophen Group
The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen
650 mg Acetaminophen
- Pain Reduction at 60 minutes [ Time Frame: 60 minutes ]The reduction of pain at 60 minutes from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088826
|Contact: Antonios Likourezos, MA, MPHfirstname.lastname@example.org|
|Contact: Christian Fromm, MDemail@example.com|
|United States, New York|
|Maimonides Medical Center||Recruiting|
|Brooklyn, New York, United States, 11219|
|Contact: Antonios Likourezos, MA, MPH 718-283-6896 firstname.lastname@example.org|
|Contact: Christian Fromm, MD 718-283-6391 email@example.com|
|Principal Investigator: Sergey Motov, MD|
|Principal Investigator:||Sergey Motov, MD||Maimonides Medical Center|