Clinical Equivalence of Controlled-Release Oxycodone 20 mg and Controlled-Release Tramadol 200 mg after Surgery for Breast Cancer

Abstract

Aims: To assess clinical equivalence of 20 mg controlled-release oxycodone (Oxygesic®; Mundipharma, Limburg, Germany) and 200 mg controlled-release tramadol (Tramal long®; Grünenthal, Aachen, Germany) on a 12-hour dosing schedule in a randomized, double-blinded study of 54 ASA I–III physical status (American Society of Anesthesiologists classification of physical status) patients undergoing surgery for breast cancer. Methods: General anesthesia using remifentanil and propofol was performed for surgery. Patients were randomly allocated to 2 groups, receiving either 20 mg controlled-release oxycodone (Oxy group) or 200 mg controlled-release tramadol (Trama group) with the premedication (7.5 mg midazolam) and again 12 hours later. All patients had access to rescue medication (i.v. paracetamol). The primary variables for clinical equivalence were the differences between the mean values for pain scores at rest and pain scores on coughing over 24 hours after operation. The equivalence margin was determined as ±10 on the visual analogue scale. Results: Fifty-four patients were enrolled. Regarding pain scores at rest, the 90% CI of the mean differences between the treatment groups over 24 hours after operation was found to be within the predefined equivalence margin [–4.5 to +1.7], and the CI values for pain scores on coughing [–6.2 to +1.7] were similar. Cumulative paracetamol given over the 24-hour observation period did not differ significantly between the Oxy group (1.32 ±1.9 g) and the Trama group (1.61 ± 1.1 g; p = 0.32). There were no significant differences between the treatment groups regarding adverse events such as nausea (p = 0.13), vomiting (p = 0.24) and itching (p = 0.77). Also, no differences were found concerning patient satisfaction scores (p = 0.8) or patients’ general perception of postoperative pain management (p = 0.71). Conclusion: 20 mg controlled-release oxycodone is clinically equivalent to 200 mg controlled-release tramadol for postoperative analgesia after surgery for breast cancer.

Safety and tolerability of controlled-release oxycodone on postoperative pain in patients submitted to the oncologic head and neck surgery

“…The rates of patient satisfaction on the overall perception of the treatment of postoperative pain found in the study by Kampe et al 22 is similar to the opinion of the investigator on the treatment used in this study.…”

Liver Cancer: Effects, Safety, and Cost-effectiveness of Controlled-Release Oxycodone for Pain Control after TACE

“…In a dosing survey study of CRO for chronic pain, Marcus et al (23) reported the effective dosage of CRO as 60-120 mg daily. The majority of studies on pain relief suggested that doses of 10-30 mg twice daily are sufficient for management of variable pain (13,16,25). In our study, we compared doses of 20 and 10 mg of CRO, and the results were mixed.…”

Oral Oxycodone for Acute Postoperative Pain: A Review of Clinical Trials

“…The occurrence of PONV associated with oral oxycodone was comparable to that of placebo (laparoscopic cholecystectomy [23], gynecological laparoscopic surgery [24], and breast surgery [22]), intravenous piritramide (caesarean section [39]), oral tramadol (breast surgery [37]) and naproxen (knee arthroscopy or inguinal hernia repair surgery [31]).…”

“…Patient satisfaction with postsurgical analgesia was generally high and comparable between treatments in most of the trials (22,24,25,31,37,39). However, the quality of pain management for oxycodone treatment was rated higher by patients undergoing spine surgery (versus placebo) (21) and retinal surgery (versus tramadol) (43), as was the quality of pain management for a multimodal regimen involving oxycodone in the setting of knee arthroplasty (versus intravenous hydromorphone) (30) and spine surgery (versus intravenous morphine or hydromorphone) (36).…”

“…The study endpoints reported were lower amounts of rescue medication/total opioid use (20,23,30,33,36,40), fewer patients requiring rescue medications (33)(34)(35), and/or a reduction in time to first rescue analgesic dose (33) in the oxycodone treatment group versus the comparator group. Few studies reported comparable rescue analgesic use between treatment groups (24,28,37,39). Demand for rescue analgesia was greater with oral oxycodone treatment compared with intrathecal morphine (caesarean section [41]) and rofecoxib (dental surgery [44]).…”