Pain Research and Management / 2017 / Article / Tab 5 / Clinical Study
Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery Safety set Group Subjects, Number of events, Incidence, (%) 95% CI (lower, upper) valueAdverse events (AE) BTDS 69 31 18 (26.1) (15.7, 36.5) 0.4037 TA 65 22 13 (20.0) (10.3, 29.7) Total 134 53 31 (23.1) (16.0, 30.3) Serious adverse event (SAE) BTDS 69 3 3 (4.4) (0.0, 9.2) 0.2450 TA 65 0 0 (0) — Total 134 3 3 (2.2) (0.0, 4,7) Adverse drug reaction (ADR) BTDS 69 19 14 (20.3) (10.8, 29.8) 0.6171 TA 65 13 11 (16.9) (7.8, 26.0) Total 134 32 25 (18.7) (12.1, 25.3) Withdrawals due to AE BTDS 69 5 4 (5.8) (0.3, 11.3) 0.1201 TA 65 0 0 (0) — Total 134 5 4 (3.0) (0.1, 5.9)
-square test; test; BTDS: buprenorphine transdermal system; TA: tramadol/acetaminophen.