Kampe, S., Wolter, K., Warm, M., Dagtekin, O., Shaheen, S., & Landwehr, S. (2009). Clinical equivalence of controlled-release oxycodone 20 mg and controlled-release tramadol 200 mg after surgery for breast cancer. Pharmacology, 84(5), 276–281.

DOI Link

Study Purpose

To assess clinical equivalence pain at rest of 20 mg controlled-release oxycodone and 200 mg controlled-release tramadol over 24 hours

Intervention Characteristics/Basic Study Process

Patients were premedicated with midazolam 7.5 mg and continuous-release oxycodone 20 mg or tramadol 200 mg. Patients received the same medication 12 hours later. After surgery, patients had access to rescue medications (paracetamol [acetaminophen]). Postoperative assessments were performed at 8, 16, and 24 hours after premedication.

Sample Characteristics

  • The sample was composed of 53 patients.
  • In the oxycodone group, mean patient age was 56.3 years; in the tramadol group, 54.9 years.
  • All the patients were female.
  • All patients underwent surgery for breast cancer ASA I–III.

Setting

  • One site
  • Inpatient
  • University of Cologne, Germany

Study Design

Randomized double-blinded study

Measurement Instruments/Methods

  • Measures of blood pressure, heart rate, respiration rate, sedation, and adverse effects
  • Visual analog scale (VAS), 100 mm, to assess pain
  • Measure of patient satisfaction

Results

There was no significant difference between treatment groups with regard to adverse effects. The cumulative amount of IV paracetamol given during the first 24 hours after the operation did not differ significantly between the two groups. Postoperative pain management and patient satisfaction were equal in both groups.

Conclusions

There were no significant differences in pain control or incidence of adverse effects between the two groups.

Limitations

  • The study had a small sample size, with fewer than 100 patients.
  • Pre-emptive analgesia may have confounded results.

Nursing Implications

Findings suggest effectiveness of continuous-release tramadol for the treatment of acute pain.