IV Tramadol – A New Treatment Option for Management of Post-Operative Pain in the US: An Open-Label, Single-Arm, Safety Trial Including Various Types of Surgery
| Autor: | Neil Singla, Scott A Reines, David A. Leiman, Mark Harnett, Michael Ryan, Lucy Lu, Harold S. Minkowitz |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
business.industry Schedule II opioid Vital signs Treatment options real-world study 03 medical and health sciences 0302 clinical medicine Anesthesiology and Pain Medicine Patient satisfaction Opioid Tolerability Clinical Trial Report 030202 anesthesiology Anesthesia Orthopedic surgery medicine multimodal analgesia Tramadol abuse risk business Adverse effect 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Journal of Pain Research |
| ISSN: | 1178-7090 |
| DOI: | 10.2147/jpr.s251175 |
| Popis: | Purpose There is a need to reduce exposure to Schedule II opioids in the United States (US) due to the ongoing opioid epidemic. Schedule II opioids have higher potential for abuse and misuse than Schedule IV opioids. This Phase 3, multicenter, single-arm, open-label, multiple-dose US trial evaluated the safety and tolerability of intravenous tramadol 50 mg, a Schedule IV opioid, in the management of postoperative pain in a real-world setting, where intravenous tramadol is not yet approved for use. Patients and methods Patients undergoing a range of soft-tissue and orthopedic surgeries were enrolled. Intravenous tramadol 50 mg was given at hours 0, 2, 4, and every 4 h thereafter through up to 7 days of treatment. Non-opioid medications per treating physicians' discretion were allowed if additional pain relief was needed. Endpoints included treatment -emergent adverse events (TEAEs), laboratories, vital signs, electrocardiograms (ECGs), and patient global assessment (PGA) of effectiveness. Results A total of 251 patients were enrolled, with 4% discontinuing due to TEAE; no patient discontinued due to a lack of efficacy. Patients averaged 13 doses, resulting in average 48 h of exposure. Intravenous tramadol was well tolerated, with TEAEs consistent with known tramadol pharmacology. No unexpected findings were observed, with 95% of patients reporting study medication was good, very good, or excellent for controlling pain. Conclusion Outcomes from this real world use study demonstrated intravenous tramadol 50 mg was safe and well tolerated in the management of postoperative pain where intravenous conventional opioids are often used. Intravenous tramadol alone or coadministered with non-opioid medication (when needed) as a multimodal combination analgesia approach resulted in high patient satisfaction with their pain relief. In light of the US opioid epidemic, reduc ing the exposure to conventional opioids in these patients via use of IV tramadol may be possible. |
| Databáze: | OpenAIRE |
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