Oliceridine for Major Surgery
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: The Cleveland Clinic
Must not be taking: Gabapentin, Pregabalin, others
Disqualifiers: Dementia, Chronic opioid use, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
The investigator will evaluate the side effects of oliceridine.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are expected to receive certain pain medications like gabapentin or pregabalin.
Eligibility Criteria
This trial is for adults over 18 who are in stable physical condition and scheduled for major noncardiac surgery that requires a hospital stay. They should need significant pain relief post-surgery but can't be chronic opioid users, have certain health conditions, or be unable to consent.Inclusion Criteria
My health is good enough for surgery, but I may have serious health problems.
I need strong pain medication equivalent to 20 mg of morphine or more.
I am scheduled for surgery with general or spinal anesthesia.
See 4 more
Exclusion Criteria
Are known to be pregnant or breastfeeding
Have language, vision, or hearing impairments that may compromise continuous ventilation monitoring
I use oxygen at home.
See 12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Oliceridine for pain control and are monitored for respiratory compromise
48 hours
Continuous monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Oliceridine (Opioid Analgesic)
Trial OverviewThe study is testing the side effects of Oliceridine, an intravenous medication given to manage pain after major surgeries. It's focused on how well it works and what adverse reactions patients might experience.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: OliceridineExperimental Treatment1 Intervention
Patients receive Oliceridine for pain control.
Oliceridine is already approved in United States for the following indications:
🇺🇸 Approved in United States as Olinvyk for:
- Management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland Clinic Fairview HospitalCleveland, OH
Wake Forest Bapist Medical CenterWinston-Salem, NC
Cleveland Clinic Main CampusCleveland, OH
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Who Is Running the Clinical Trial?
The Cleveland ClinicLead Sponsor
References
MetaADEDB 2.0: a comprehensive database on adverse drug events. [2021]MetaADEDB is an online database we developed to integrate comprehensive information on adverse drug events (ADEs). The first version of MetaADEDB was released in 2013 and has been widely used by researchers. However, it has not been updated for more than seven years. Here, we reported its second version by collecting more and newer data from the U.S. FDA Adverse Event Reporting System (FAERS) and Canada Vigilance Adverse Reaction Online Database, in addition to the original three sources. The new version consists of 744 709 drug-ADE associations between 8498 drugs and 13 193 ADEs, which has an over 40% increase in drug-ADE associations compared to the previous version. Meanwhile, we developed a new and user-friendly web interface for data search and analysis. We hope that MetaADEDB 2.0 could provide a useful tool for drug safety assessment and related studies in drug discovery and development.
Characteristics of adverse event reporting of Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to the US Food and Drug Administration. [2023]BACKGROUND: On September 9, 2021, the US Food and Drug Administration (FDA) issued a drug safety communication and required revisions to the Boxed Warning for Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib) to include information about the risk of serious heart-related events, cancer, blood clots, and death. The Boxed Warning was based on a large safety randomized clinical trial of tofacitinib, but neither baricitinib nor upadacitinib has been studied in similar large safety clinical trials. OBJECTIVE: To evaluate characteristics of adverse event (AE) reporting of tofacitinib/XR, baricitinib, and upadacitinib to the FDA. METHODS: We analyzed the public FDA's Adverse Event Reporting System data to examine reported AEs that were related to any of the 3 drugs between January 1, 2019, and September 30, 2021. Both brand and generic names of these drugs were used to identify these AEs. Frequencies of AE reports were evaluated by patient demographics (age and sex), type of reporter, reporter region, seriousness, and reactions related to death, cardiovascular, cancer, and blood clots. Chi-square tests were used to compare the proportion of characteristics of AEs between these drugs at P < 0.05. RESULTS: We identified 56,833 AE reports of tofacitinib/XR, 2,318 reports of baricitinib, and 5,359 reports of upadacitinib. Higher proportions of patients reporting AEs for tofacitinib/XR were older and female than for baricitinib and upadacitinib. Higher proportions of tofacitinib/XR and baricitinib AEs were reported by health professionals than for upadacitinib. Higher proportions of upadacitinib AEs were in the United States and more serious than those of tofacitinib/XR and baricitinib AEs (all group and paired comparisons at P < 0.05). Regarding reactions, baricitinib AEs had highest proportions of death (7.2%) and cancer-related (4.1%) events, whereas tofacitinib/XR AEs had the highest proportions of cardiovascular-related (14.1%) and blood clot-related (14.8%) events. CONCLUSIONS: Although baricitinib and upadacitinib are in the same drug class as tofacitinib/XR, their risk of serious cardiovascular events, cancer, blood clots, and death might not be similar. Findings from this hypothesis-generating study suggest that there may be differential AEs between Janus kinase inhibitors, and therefore, future research for robust comparative safety is warranted.
Retrospective Analysis of the Safety and Efficacy of Sugammadex Versus Neostigmine for the Reversal of Neuromuscular Blockade in Children. [2020]Sugammadex, with its novel mechanism of action of encapsulation and noncompetitive binding of aminosteroid neuromuscular-blocking agents (rocuronium and vecuronium), may offer distinct advantage to pediatric patients where residual neuromuscular blockade may be poorly tolerated. Data describing its use in the pediatric population are limited, and no large-scale studies are available evaluating the occurrence of adverse event across the full spectrum of ages. We sought to measure the occurrence of adverse events, assess the severity and clinical significance of the events, and quantify a surrogate measure of efficacy of sugammadex compared to neostigmine in a large population and in the full age range of children.
OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications. [2022]Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs.
Adverse events related to radium-223 treatment: "real-life" data from the Eudra-Vigilance database. [2021]The aim of our study was to analyze adverse events (AEs) associated with radium-223 using real life data from Eudra-Vigilance (EV) database.