Rodriguez, R.F., Castillo, J.M., Castillo, M.P., Montoya, O., Daza, P., Rodriguez, M.F., . . . Angel, A.M. (2008). Hydrocodone/acetaminophen and tramadol chlorhydrate combination tablets for the management of chronic cancer pain: A double-blind comparative trial. The Clinical Journal of Pain, 24(1), 1–4.

DOI Link

Study Purpose

To compare the efficacy of hydrocodone-acetaminophen with that of tramadol in the management of cancer pain; to compare the tolerability of hydrocodone-acetaminophen and tramadol used to relieve cancer pain

Intervention Characteristics/Basic Study Process

Patients were assigned to receive either hydrocodone-acetaminophen (25 mg hydrocodone, 2,500 acetaminophen) or tramadol (200 mg) for 21 days. Patients rated pain intensity at the beginning of the study, two days after the beginning of the study, and once weekly for three weeks. Patients were to note all adverse events.

Sample Characteristics

  • The sample was composed of 118 patients.
  • In the hydrocodone-acetaminophen group, mean patient age was 62 years. In the tramadol group, mean patient age was 57.1 years.
  • In the hydrocodone-acetaminophen group, 35.5% were female and 64.5% were male. In the tramadol group, 62.5% were female and 37.5% were male.
  • In the entire sample, 13.5% of patients had pain due to gastric cancer; 12%, to breast cancer; 13.5%, to prostate cancer; and 89%, to lung cancer.

Setting

  • Multisite
  • Outpatient
  • Colombia

Study Design

Randomized double-blind comparative trial

Measurement Instruments/Methods

  • Visual analog scale, 100 mm, to measure pain intensity
  • Scale of adverse events (none = 0, mild = 1, moderate = 2, severe = 3)

Results

  • The difference in pain relief between the groups was not significant. Tramadol caused significantly more nausea (P = 0.03), vomiting (P = 0.02), dizziness (P = 0.03), loss of appetite (P = 0.02), and weakness (P = 0.019) than did hydrocodone-acetaminophen.
  • Authors noted no significant differences between groups in regard to dry mouth or constipation.

Conclusions

In this study, tramadol and hydrocodone-acetaminophen were equally efficacious in relieving cancer pain. Patients taking hydrocodone-acetaminophen experienced fewer side effects than did patients who took tramadol.

Limitations

All analgesics, except medications for neuropathic pain, were discontinued. Note that the group that took tramadol contained significantly more women than did the group that took hydrocodone-acetaminophen. This difference may relate to the differing side-effect profiles.

Nursing Implications

This study showed that hydrocodone-acetaminophen and tramadol were equally effective at treating cancer pain; however, tramadol was associated with more adverse effects. Nurses should keep this in mind and provide patients with anticipatory guidance as appropriate.