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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.
J Pain Res. 2020; 13:1155-1162.JP

Abstract

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, reducing the exposure to conventional opioids in these patients via use of IV tramadol may be possible.

Authors+Show Affiliations

Clinical Research, HD Research, Bellaire, TX, USA.Clinical Research, HD Research, Bellaire, TX, USA.Clinical Operations, Avenue Therapeutics, New York, NY, USA.Clinical Operations, Avenue Therapeutics, New York, NY, USA.Clinical Operations, Avenue Therapeutics, New York, NY, USA.Clinical Operations, Avenue Therapeutics, New York, NY, USA.Clinical Research, Lotus Clinical Research, Pasadena, CA, USA.

Pub Type(s)

Case Reports

Language

eng

PubMed ID

32547178

Citation

Minkowitz, Harold, et al. "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." Journal of Pain Research, vol. 13, 2020, pp. 1155-1162.
Minkowitz H, Leiman D, Lu L, et al. 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. J Pain Res. 2020;13:1155-1162.
Minkowitz, H., Leiman, D., Lu, L., Reines, S., Ryan, M., Harnett, M., & Singla, N. (2020). 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. Journal of Pain Research, 13, 1155-1162. https://doi.org/10.2147/JPR.S251175
Minkowitz H, et al. 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. J Pain Res. 2020;13:1155-1162. PubMed PMID: 32547178.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Minkowitz,Harold, AU - Leiman,David, AU - Lu,Lucy, AU - Reines,Scott, AU - Ryan,Michael, AU - Harnett,Mark, AU - Singla,Neil, Y1 - 2020/05/22/ PY - 2020/03/03/received PY - 2020/04/28/accepted PY - 2020/6/18/entrez PY - 2020/6/18/pubmed PY - 2020/6/18/medline KW - abuse risk KW - multimodal analgesia KW - real-world study KW - Schedule II opioid SP - 1155 EP - 1162 JF - Journal of pain research JO - J Pain Res VL - 13 N2 - 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, reducing the exposure to conventional opioids in these patients via use of IV tramadol may be possible. SN - 1178-7090 UR - https://www.unboundmedicine.com/medline/citation/32547178/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 L2 - https://dx.doi.org/10.2147/JPR.S251175 DB - PRIME DP - Unbound Medicine ER -
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