Opioid Analgesic
Oxycodone Acetaminophen for Pain
Saint Louis University, Saint Louis, MO
Targeting 5 different conditionsOxycodone Acetaminophen +6 morePhase 3RecruitingLed by David Greenberg, MDResearch Sponsored by St. Louis UniversityEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Plan to undergo prophylactic intramedullary nailing of one or both femurs
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to six weeks post-op
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 10 Other Conditions
Study Summary
This trial looks at the effects of post-operative pain medication on patients who have had a prophylactic intramedullary femoral nail placed.
Eligible Conditions
- Pain
- Lymphoma
- Multiple Myeloma
- Opioid Use Disorder
- Bone Metastases
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are planning to have a medical procedure called prophylactic intramedullary nailing on one or both of your thigh bones.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to six weeks post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to six weeks post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Milligram Morphine Equivalent (MME) of Opioid Medications Utilized
Secondary outcome measures
Numerical Rating Scale (NRS)
Patient Reported Outcomes Measurement System (PROMIS) Pain Intensity Scale
Single Assessment Numerical Evaluation (SANE)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental ArmExperimental Treatment6 Interventions
For the first 24 hours following surgery, patients younger than 65 years old will be administered a maximum of 120 mg/day bolus IV ketorolac (30 mg every 6 hours). Patients older than 65 years old or with history of advanced renal impairment will receive a maximum of 60 mg/day bolus IV ketorolac (15 mg every 6 hours). All patients may also be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate- severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. At discharge, they will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours, quantity 50. Those with preexisting liver disease will be prescribed the equivalent in oxycodone and will not receive acetaminophen for mild pain.
Group II: ControlPlacebo Group6 Interventions
Following surgery, patients will be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate-severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. They will also be given a placebo injection of normal saline every 6 hours for the first 24 hours following surgery. At discharge, patients will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours PRN quantity 50, unless they have preexisting liver disease, in which case they will be prescribed the equivalent in oxycodone. They will not receive a nerve block.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxycodone
FDA approved
Hydrocodone
FDA approved
Ketorolac
FDA approved
Morphine
FDA approved
Acetaminophen
FDA approved
Oxycodone
FDA approved
Find a site
Who is running the clinical trial?
St. Louis UniversityLead Sponsor
192 Previous Clinical Trials
43,607 Total Patients Enrolled
David Greenberg, MDPrincipal Investigator - St. Louis University
St. Louis University Hospital
Georgetown University School Of Medicine (Medical School)
University Mo-Columbia School Medicine (Residency)
1 Previous Clinical Trials
38 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there harmful effects of Oxycodone Acetaminophen if misused?
"There is some efficacy data and multiple rounds of safety data, making Oxycodone Acetaminophen a 3 on our safety scale."
Answered by AI
What other scholarly papers have been published on Oxycodone Acetaminophen?
"As of now, there are a total of 199 ongoing trials for Oxycodone Acetaminophen with 51 of those trials being in Phase 3. Boston, Massachusetts has a significant amount of these studies, but in total, there are 1189 locations running these trials."
Answered by AI
How many participants are recruited for this clinical trial?
"That is correct. The information available on clinicaltrials.gov supports that this research study is still actively looking for patients. The details of the posting indicate that the trial was first advertised on February 20th, 2019 and was last updated on December 2nd, 2021. They are seeking a total of 60 individuals from 1 location."
Answered by AI
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