Abstract: AIM: To evaluate the safety and efficacy of oral oxycodone/acetaminophen or tramadol in early postoperative patients undergoing laparoscopic gynecological operations.METHODS: 120 gynecologic patients receiving laparoscopy operation were enrolled in a randomized, double-blind, placebo-controlled, multi-center clinical trial with early oral analgesics if the vasual analgesia scores (VAS)was scored higher than 3.0.All patients were randomly received a single dose of oral analgesic: oxycodone/acetaminophen, tramadol or placebo, respectively.For rescue medication, PCA pump was provided in all three groups with a dose of 1mg morphine and lockout of 5 minutes.The VAS scores, pain relief, PCA morphine consumption and side effects were evaluated at the following occasions of 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12 and 24 h throughout the study.RESULTS: The VAS scores and pain relief were significantly different in three groups at 0.75, 1, 2, 4, 6, 8 and 12 h.The VAS scores and PCA morphine consumption was significantly lower in oxycodone/acetaminophen and tramadol groups than those in placebo group.Pain relief in oxycodone/acetaminophen and tramadol groups was better than those in placebo group.The incidence of side effects such as nausea and vomiting significantly increased in tramadol group at 24 h compared with those in the other two groups. CONCLUSION: Early oral administration of oxycodone/acetaminophen or tramadol can provide surgical patients with good and safe postoperative analgesia after laparoscopy gynecologic operation.The incidence of side effects in oxycodone/acetaminophen group is lower than that in tramadol group in this clinical trial.

Key words: oral analgesic, oxycodone/acetaminophen, tramadol, postoperative analgeisa