Adverse Reactions Following First-Dose Administration of Co-Crystal of Tramadol-Celecoxib Versus Tramadol Alone for Moderate-To-Severe Acute Pain.

研究概要

Three hundred sixty-seven patients with moderate-to-severe acute postoperative pain following first metatarsal osteotomy were analyzed after receiving a first dose of CTC 200 mg (n=183) or tramadol 50 mg (n=183). The pupose was to provide a descriptive snapshot of first-dose tolerability. The primary outcome of interest for this post-hoc analysis was the prevalence of study drug–related, opioid-associated adverse reactions (somnolence, nausea, dizziness, vomiting) at 2, 4, and 6 hours after the first dose; no formal inferential testing was planned. Outcomes were assessed up to 6 hours (just prior to the second dose). Overall, the results revealed similar proportions of these adverse reactions at each timepoint between CTC and tramadol despite the higher tramadol content in CTC (88 mg vs 50 mg). These findings suggest first-dose tolerability of CTC is comparable to tramadol 50 mg in this setting.